Cystinosis Global Clinical Trials Review, H2, 2015, New Report Launched

Cystinosis Global Clinical Trials Review, H2, 2015 report provides an overview of Cystinosis clinical trials scenario. This report provides top line data relating to the clinical trials on Cystinosis. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.

Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). Global Data Clinical Trial Reports are generated using Global Data’s proprietary database – Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.

The report enhances the decision making capabilities and helps to create an effective counter strategies to gain competitive advantage.

Scope

  • The report provides a snapshot of the global clinical trials landscape
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
  • The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
  • The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
  • The Report provides enrollment trends for the past five years
  • Report provides latest news for the past three months

Reasons to buy

  • Assists in formulating key business strategies with regards to investment
  • Helps in identifying prominent locations for conducting clinical trials which saves time and cost
  • Provides top level analysis of Global Clinical Trials Market which helps in identifying key business opportunities
  • Supports understanding of trials count and enrollment trends by country in global therapeutics market
  • Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
  • Facilitates clinical trial assessment of the indication on a global, regional and country level

Spanning over 69 pages Cystinosis Global Clinical Trials Review, H2, 2015” report covers Introduction, Clinical Trials by Region, Clinical Trial Profiles, Appendix. This report Covered 3 Companies – Raptor Pharmaceuticals Corp., Sigma-Tau S.p.A., ICON Plc.

For further information on this report, please visit- http://mrr.cm/opd

Related Reports are:

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2nd – Proteinuria Global Clinical Trials Review, H2, 2015 – Visit at – http://mrr.cm/opW

3rd – Renal Stones/Calculi Global Clinical Trials Review, H2, 2015 – Visit at – http://mrr.cm/opm

About Market Research Reports, Inc.

Market Research Reports, Inc. is the world’s leading source for market research reports and market data. We provide you with the latest market research reports on global markets, key industries, leading companies, new products and latest industry analysis & trends.

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China; New Report Launched

China’s healthcare market is indispensable for overseas and multinational pharmaceutical companies, but Chinese regulations on pharmaceutical clinical trials are undergoing sharp changes. This is first time in history, Chinese pharmaceutical authorities officially issued a guidance on international multi-center clinical trials of drugs in China, which has begun to be implemented on March 1, 2015. To enter into Chinese lucrative drug market, the overseas and multinational pharmaceutical manufacturers must be compliance with this latest regulations. How do respond such challenges? The overseas and multinational pharmaceutical anufacturers and their senior executive officers engaging in regulatory affairs must have a comprehensive and thorough knowledge of the Guidance on Chinese international multi-center clinical trials of drugs, and must be compliance with the latest regulations.

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China provided a comprehensive and thorough knowledge of the Guidance on international multi-center clinical trials of drugs in China and guide you use the Chinese trial venues to keep drug development lean and to smoothly operate in China step by step.

The organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of the Chinese regulatory authorities — China Food and Drug Administration (CFDA) being responsible for application and approval for international multi-center clinical trials of drug registration to give the direction of gateway for application for approval of clinical trial of imported overseas drug registration. Chapter 3 elaborates the background of promulgating Guidance. Chapter 4 introduces the applicable scope of Guidance. Chapter 5 introduces the general requirements of international multi-center clinical trials of drugs in China. Chapter 6 elaborates a series of scientific issues that Guidance requires sponsors to be considered. Chapter 7 elaborates a series of compliance issues that Guidance requires sponsors to be considered. Chapter 8 elaborates the clinical trial protocol amendment. Chapter 9 introduces the requirements for using the data from international multi-center clinical trials to support the application for drug registration in China. Chapter 10 introduces the authority, objects, contents, scope and requirements of Chinese drug regulatory authorities implementing inspection and verification on clinical trial sites. Chapter 11 provides a comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step. Chapter 12 provides a comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges. Chapter 13 Appendices provide a complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include “Application Form of Drug Registration”, “Application Form for Special Examination and Approval of New Drug Registration”, and “Application Form for Communication of Special Examination and Approval of New Drug Registration”.

The audiences of this guidebook are overseas pharmaceutical manufacturers wishing to enter into the Chinese drug market, and multinational pharmaceutical companies have penetrated into the Chinese drug market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for international multi-center clinical trials and registration of their pharmaceutical products in China, how to comply with the latest guidance on international multi-center clinical trials of drugs in China.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest guidance on international multi-center clinical trials of drugs in China but also the practical operation how to comply with the latest guidance on international multi-center clinical trials of drugs in China. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug market, and smoothly operate their products in China.

Report Highlights

  • An overview of organizational structure of Chinese regulatory authorities — China Food and Drug Administration (CFDA) for approval for international multi-center clinical trials in China to give the direction of gateway for clinical trials of imported drugs.
  • The background of promulgating Guidance.
  • The applicable scope of Guidance.
  • The general requirements of international multi-center clinical trials of drugs in China.
  • A series of scientific issues that overseas sponsors must be considered.
  • A series of compliance issues that overseas sponsors must be considered.
  • The detailed requirements for using the data from international multi-center clinical trials to support the application for imported overseas drug registration in China.
  • Chinese drug regulatory authorities how to implement the inspection and verification on clinical trial sites.
  • A comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step.
  • An entrie process of application and approval procedures for international multi-center clinical trials of drugs in China.
  • The detailed regulations on registration and information disclosure for international multi-center clinical trials of drugs in China.
  • A comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges.
  • A complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include “Application Form of Drug Registration”, “Application Form for Special Examination and Approval of New Drug Registration”, and “Application Form for Communication of Special Examination and Approval of New Drug Registration”.
  • Scope
  • Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China provided a comprehensive and thorough knowledge of the Guidance on international multi-center clinical trials of drugs in China and guide you use the Chinese trial venues to keep drug development lean and to smoothly operate in China step by step.

Reasons to Buy

China’s healthcare market is indispensable for overseas and multinational pharmaceutical companies, but Chinese regulations on pharmaceutical clinical trials are undergoing sharp changes. This is first time in history, Chinese pharmaceutical authorities officially issued a guidance on international multi-center clinical trials of drugs in China, which has begun to be implemented on March 1, 2015. To enter into Chinese lucrative drug market, the overseas and multinational pharmaceutical manufacturers must be compliance with this latest regulations. How do respond such challenges?  The overseas and multinational pharmaceutical anufacturers and their senior executive officers engaging in regulatory affairs must have a comprehensive and thorough knowledge of the Guidance on Chinese international multi-center clinical trials of drugs, and must be compliance with the latest regulations.To understand the latest guidance on international multi-center clinical trials of drugs in China, you must read the Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China.

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China provided a comprehensive and thorough knowledge of the Guidance on international multi-center clinical trials of drugs in China and guide you use the Chinese trial venues to keep drug development lean and to smoothly operate in China step by step.

Key Highlights

  • An overview of organizational structure of Chinese regulatory authorities — China Food and Drug Administration (CFDA) for approval for international multi-center clinical trials in China to give the direction of gateway for clinical trials of imported drugs.
  • The background of promulgating Guidance.
  • The applicable scope of Guidance.
  • The general requirements of international multi-center clinical trials of drugs in China.
  • A series of scientific issues that overseas sponsors must be considered.
  • A series of compliance issues that overseas sponsors must be considered.
  • The detailed requirements for using the data from international multi-center clinical trials to support the application for imported overseas drug registration in China.
  • Chinese drug regulatory authorities how to implement the inspection and verification on clinical trial sites.
  • A comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step.
  • An entrie process of application and approval procedures for international multi-center clinical trials of drugs in China.
  • The detailed regulations on registration and information disclosure for international multi-center clinical trials of drugs in China.
  • A comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges.
  • A complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include “Application Form of Drug Registration”, “Application Form for Special Examination and Approval of New Drug Registration”, and “Application Form for Communication of Special Examination and Approval of New Drug Registration”.

Spanning over 101 pages, Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China” report covers the Executive Summary, An Overview of Chinese Regulatory Authorities for Drug Clinical Trials, Background, Applicable Scope, General Requirements, Consideration for Scientific Issues, Consideration for Compliance Issues, Clinical Trial Protocol Amendment, Application for Drug Registration, Inspection and Verification on Sites, Practical Guidance for Application and Approval of Pharmaceutical International Multi-Center Clinical Trials in China, A Comprehensive Analysis, Appendices.

For more information see –  http://mrr.cm/4xU

Find all Clinical Trials Reports at: http://www.marketresearchreports.com/clinical-trials

About Market Research Reports, Inc.

Market Research Reports, Inc. is the world’s leading source for market research reports and market data. We provide you with the latest market research reports on global markets, key industries, leading companies, new products and latest industry analysis & trends.

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition), New Report Launched

China’s regulatory framework for medical devices is undergoing radical changes. The country’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, which has come into force as of June 1, 2014. Before long, China Food and Drug Administration (hereafter called as CFDA) issued the latest “Measures for the Administration of Medical Device Registration”, which has come into force as of October 1, 2014.The overseas medical devices exporting into China market are subject to administration of overall new regulations on medical device registration since October 1, 2014.

In 2009, the Chinese government vigorously launched “China’s Health-Care Reform”, developed an ambitious blueprint, in which health care system covered about 1.2 billion people by 2011. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare market has reached 179 billion RMB (about 29 billion US dollars). Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. On the Chinese medical device market, imported medical devices made by overseas and multinational medical device manufacturers account for about a half, in which the high-tech and high-valued medical devices, such as magnetic resonance imaging, CT are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 57 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States. The Chinese medical device market is one of segment market of the most growth potentiality, which is attracting more and more overseas medical device manufacturers and producers to penetrate such market.

China’s radical change of regulatory framework for medical devices brings overseas and multinational medical device manufacturers the maximum challenges and opportunities. Those overseas medical devices have not been granted the certificate of marketing authorization of medical device issued by the government authorities of the country or region of origin have been intercepted outside the door of Chinese clinical trial market not only, and be blocked outside the door of Chinese medical device market also. Nonetheless, Chinese authorities relaxed the admittance license of overseas medical devices. The overseas medical device manufacturer exporting Class I medical devices into China only need to file the archives and the certificate of marketing authorization of the government authorities of the country or region of origin to the CFDA for recordation. The overseas medical device manufacturer exporting Class II and Class III medical devices into China should be subject to be examined and approved by the CFDA. The Chinese authorities will strengthen the supervision and administration for medical devices, including their registration, production, distribution and use. How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How do you conduct the clinical evaluation and clinical trial for your products exporting into the Chinese market?

The Chinese concept of clinical evaluation and clinical trial for medical device registration is unique, which is distinct from the clinical trial in U.S. and EU countries.

In China, the process of application and approval for clinical evaluation and clinical trial of imported medical device registration is very complex, because the Chinese medical device authorities administer and control this process by exorbitant administrative measures and regulations, even the guidances. Moreover, these exorbitant administrative measures and regulations, and the guidances are variable and lack of transparency. In addition, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational medical device manufacturers and producers.

To enter such a lucrative medical device market, overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device clinical evaluation and clinical trial. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

Scope of the report:

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical evaluation and clinical trial for imported medical device registration but also introduced the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep medical device development lean and achieve a successful approval for your products entry into the Chinese medical device market.

The organizations of this guidebook are arranged as follows.

Chapter 2 introduces the framework of the latest Chinese applicable regulations for clinical evaluation and clinical trial of medical device registration to provide a comprehensive and thorough knowledge of the latest Chinese regulations for clinical evaluation and clinical trial of medical device registration.

Chapter 3 provides a comprehensive comparative analysis to tell overseas medical device manufacturer what Chinese regulations on medical device registration are undergoing radical changes, from what Chinese regulations on imported medical device registration are undergoing radical changes to what overseas medical devices need to conduct the clinical evaluation or clinical trial for imported medical device registration.

Chapter 4 provides an overview of the Chinese regulatory authorities — China Food and Drug Administration (CFDA) being responsible for application and approval for clinical evaluation and clinical trial of imported medical device registration to give the direction of gateway for application for approval of clinical trial of imported overseas medical device registration.

Chapter 5 elaborates the knowledge preparation before consucting the clinical evaluation and clinical trial for imported medical device registration to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration and lay the knowledge foundation for the practical operation.

Chapter 6 elaborates the medical device classification to let overseas medical device manufacturer understand the Chinese medical device classification, because the imported overseas medical device registration must be in compliance with such classification of medical devices.

Chapter 7 introduces the rights of human subjects and every party’s responsibilities in clinical trials for imported overseas medical devices in China.

Chapter 8 introduces the unique Chinese regulations for clinical evaluation and clinical trial of imported medical device registration to help overseas medical device manufacturers to remove their confusion.

Chapter 9 provides the practical guidance for applying for clinical trials of imported overseas medical device registration, from what imported overseas medical devices need to conduct clinical trial and approval within chinese territory, how to apply for clinical trial of imported overseas medical device registration, how to compile the product technical requirements, how to compile application documents to how to acquire the approval document for clinical trial of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.

Chapter 10 provides the practical guidance for conducting clinical evaluation of imported overseas medical device registration, also from what imported overseas medical devices need to conduct clinical evaluation of imported overseas medical device registration, what requirements are for conducting clinical evaluation of imported overseas medical device registration, how to conduct the clinical evaluation of imported overseas medical device registration to how to compile application documents to smoothly navigate complex regulatory requirements step by step.

Chapter 11 Appendices provide a complete set of full text in English of the latest Chinese applicable regulations for medical device clinical evaluation and clinical trial of imported overseas medical device registration, which include “Regulations for the Supervision and Administration of Medical Devices (2014 Edition)”, “Measures for the Administration of Medical Device Registration (2014 Edition)”, “Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)”, “Rules for Medical Device Classification (2014 Edition)” , “Provisions for Clinical Trials of Medical Devices” and “Technical Guidance Principles for Clinical Evaluation of Medical Devices”.

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to smoothly conduct clinical evaluation and clinical trial for their medical device product registration in China, and how to comply with the Chinese GCP.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of latest Chinese regulations on clinical evaluation and clinical trial for imported overseas medical device registration but also the practical operation how to comply with the Chinese GCP, how to conduct the clinical evaluation and clinical trial for imported overseas medical device registration. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate laws and regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate the clinical evaluation and the clinical trial for their products in China.

See this report at – http://mrr.cm/ZKW

Report Highlights:

  • An overview of the latest Chinese applicable regulations for clinical evaluation and clinical trial of medical device registration.
  • A comprehensive comparative analysis —- what Chinese regulations on medical device registration are undergoing radical changes.
  • An overview of organizational structure of Chinese regulatory authorities for clinical evaluation and clinical trial of imported overseas medical devices registration to give the direction of gateway for application for approval of clinical trial for imported overseas medical device registration.
  • The knowledge preparation before consucting the clinical evaluation and clinical trial for imported overseas medical device registration to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration and lay the knowledge foundation for the practical operation.
  • The detailed Chinese classification for medical devices.
  • The rights of human subjects and every party’s responsibilities in clinical trials for imported overseas medical device registration in China.
  • The unique Chinese regulations for clinical evaluation and clinical trial of imported overseas medical device registration to help overseas medical device manufacturers to remove their confusion.
  • The practical guidance for applying for clinical trials of imported overseas medical device registration, from what imported overseas medical devices need to conduct clinical trial and approval within Chinese territory, how to apply for clinical trial of imported overseas medical device registration, how to compile the product technical requirements, how to compile application documents to how to acquire the approval document for clinical trial of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.
  • The practical guidance for conducting clinical evaluation of imported overseas medical device registration, also from what imported overseas medical devices need to conduct clinical evaluation of imported overseas medical device registration, what requirements are for conducting clinical evaluation of imported overseas medical device registration, how to conduct the clinical evaluation of imported overseas medical device registration to how to compile application documents to smoothly navigate complex regulatory requirements step by step.
  • A complete set of full text in English of the latest Chinese applicable regulations for medical device clinical evaluation and clinical trial of imported overseas medical device registration, which include “Regulations for the Supervision and Administration of Medical Devices (2014 Edition)”, “Measures for the Administration of Medical Device Registration (2014 Edition)”, “Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)”, “Rules for Medical Device Classification (2014 Edition)” , “Provisions for Clinical Trials of Medical Devices” and “Technical Guidance Principles for Clinical Evaluation of Medical Devices”.

Reasons to Buy:

China’s regulatory framework for medical devices is undergoing radical changes. The country’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, which has come into force as of June 1, 2014. Before long, China Food and Drug Administration (hereafter called as CFDA) issued the latest “Measures for the Administration of Medical Device Registration”, which has come into force as of October 1, 2014.The overseas medical devices exporting into China market are subject to administration of overall new regulations on medical device registration since October 1, 2014.

The Chinese concept of clinical evaluation and clinical trial for medical device registration is unique, which is distinct from the clinical trial in U.S. and EU countries. How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How do you conduct the clinical evaluation and clinical trial for your products exporting into the Chinese market?

To enter such a lucrative medical device market, overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device clinical evaluation and clinical trial. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical evaluation and clinical trial for imported medical device registration but also introduced the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep medical device development lean and achieve a successful approval for your products entry into the Chinese medical device market.

The overseas medical device manufacturers wishing to enter into the Chinese medical device market, the multinational medical device manufacturers have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs for clinical evaluation and clinical trial of exporting overseas medical device into Chinese lucrative medical device market, senior executive officers engaging in applying for approval of exporting overseas medical device registration in China need to understand these latest Chinese registrations and the practical operation. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget, and cause trouble for your business smoothly in China.

Know more about this report at – http://mrr.cm/ZKW

Find all Medical Devices Report at: – http://www.marketresearchreports.com/medical-devices

About Market Research Reports, Inc.

Market Research Reports, Inc. is the world’s leading source for market research reports and market data. We provide you with the latest market research reports on global markets, key industries, leading companies, new products and latest industry analysis & trends.

Thrombosis Global Clinical Trials Review, H2, 2014, New Report Launched

Thrombosis Global Clinical Trials Review, H2, 2014 report provides data on the Thrombosis clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Thrombosis. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Thrombosis. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

Scope

  • Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations
  • Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type
  • Listings of discontinued trials (suspended, withdrawn and terminated)

Reasons to buy

  • Understand the dynamics of a particular indication in a condensed manner
  • Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more
  • Obtain discontinued trial listing for trials across the globe
  • Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies

Spanning over 154 pages, “Thrombosis Global Clinical Trials Review, H2, 2014” report covering the Introduction, Report Guidance, Clinical Trials by Region, Clinical Trials by Phase, Clinical Trial Profiles, Appendix.

Know more about this report at – http://mrr.cm/Zze

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1st – Unstable Angina Global Clinical Trials Review, H2, 2014 – visit at: http://mrr.cm/Zzn

2nd – Vascular Calcification Global Clinical Trials Review, H2, 2014 – visit at: http://mrr.cm/Zzh

3rd – Vasospastic Angina Global Clinical Trials Review, H2, 2014 – visit at: http://mrr.cm/Zz7

About Market Research Reports, Inc.

Market Research Reports, Inc. is the world’s leading source for market research reports and market data. We provide you with the latest market research reports on global markets, key industries, leading companies, new products and latest industry analysis & trends.

Clinical Trials Market in India 2014, New Report Launched

Clinical Trials Market in India 2014 report analyses how India is a potential global hub for conducting clinical trials by Indian as well as global pharmaceutical companies. Clinical trials are conducted on humans to examine the efficacy and safety of new drugs, treatments, therapies and new medical devices before launching them in the market. It is a necessary and final step for the completion of the drug development process. The market is divided into four phases – Phase I, Phase II, Phase III and Phase IV. Contract Research Organizations (CROs) are responsible for designing, monitoring, and managing clinical trials. The market is dominated by private players and foreign pharmaceutical companies.

The clinical research market in India has comparative advantage in conducting clinical trials regarding cost efficiency and a vast population suffering from acute chronic diseases. Government regulations regarding the compensation rule and approval time are hampering the market at present, but the situation is expected to improve soon. Apart from the pharma companies there are several research institutes involved in R&D of clinical trials. Increasing partnerships and changes in the regulatory environment are crucial future driving factors for this market.

Spanning over 77 pages, “Clinical Trials Market in India 2014” report covering the Executive Summary, Introduction, Market Overview, Drivers & Challenges, Government Participation, Competitive Landscape, Clinical Research Institutes, Recent Developments, Strategic Recommendations, Appendix. This report Covered 18 Companies – Clininvent Research Pvt. Ltd., SIRO Clinpharm Pvt. Ltd., Sristek Clinical Research Solutions Ltd., Synchron Research Services Pvt. Ltd., Clintech Research India Pvt. Ltd., ICON Clinical Research India Pvt. Ltd., PAREXEL International (India) Pvt. Ltd., Quintiles Research (India) Pvt. Ltd., Advanced Centre for Treatment, Research and Education in Cancer, Central Drug Research Institute (CDRI), Institute of Cytology & Preventive Oncology, National AIDS Research Institute, National Brain Research Center, National Institute of Cholera and Enteric Diseases, National Institute of Immunology, National Institute of Nutrition, National Institute of Virology (NIV), Tuberculosis Research Centre (TRC).

Know more about this report at – http://mrr.cm/ZuE

Find all Clinical Trials Reports at: http://www.marketresearchreports.com/clinical-trials

About Market Research Reports, Inc.

Market Research Reports, Inc. is the world’s leading source for market research reports and market data. We provide you with the latest market research reports on global markets, key industries, leading companies, new products and latest industry analysis & trends.

Chronic Heart Failure Global Clinical Trials Review, H2, 2014, New Report Launched

Chronic Heart Failure Global Clinical Trials Review, H2, 2014” provides data on the Chronic Heart Failure clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Chronic Heart Failure. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Chronic Heart Failure. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

  • Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations
  • Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type
  • Listings of discontinued trials (suspended, withdrawn and terminated)

Reasons to buy

  • Understand the dynamics of a particular indication in a condensed manner
  • Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more
  • Obtain discontinued trial listing for trials across the globe
  • Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies

Spanning over 102 pages, “Chronic Heart Failure Global Clinical Trials Review, H2, 2014” report covering the Introduction, Report Guidance, Clinical Trials and Average Enrollment by Country, Clinical Trial Profiles, Appendix.

Know more about this report at – http://mrr.cm/Z6u

Related reports;

1st – Chronic Thromboembolic Pulmonary Hypertension Global Clinical Trials Review, H2, 2014 – visit at: http://mrr.cm/Z6L

2nd- Coronary Artery Disease (CAD) (Ischemic Heart Disease) Global Clinical Trials Review, H2, 2014 – visit at: http://mrr.cm/Z6b

About Market Research Reports, Inc.

Market Research Reports, Inc. is the world’s leading source for market research reports and market data. We provide you with the latest market research reports on global markets, key industries, leading companies, new products and latest industry analysis & trends.

Acute Respiratory Distress Syndrome Global Clinical Trials Review, H2, 2014, New Report Launched

Acute Respiratory Distress Syndrome Global Clinical Trials Review, H2, 2014” provides data on the Acute Respiratory Distress Syndrome clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Acute Respiratory Distress Syndrome. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Acute Respiratory Distress Syndrome. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

  • Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations
  • Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type
  • Listings of discontinued trials (suspended, withdrawn and terminated)

Reasons to buy

  • Understand the dynamics of a particular indication in a condensed manner
  • Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more
  • Obtain discontinued trial listing for trials across the globe
  • Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies

Spanning over 80 pages, “Acute Respiratory Distress Syndrome Global Clinical Trials Review, H2, 2014” report covering the Introduction, Acute Respiratory Distress Syndrome, Report Guidance, Clinical Trial Profiles, Appendix.

Know more about this report at – http://mrr.cm/Z6E

Related reports;

1st – Adult Respiratory Distress Syndrome Global Clinical Trials Review, H2, 2014 – visit at: http://mrr.cm/Z6a

2nd- Neonatal Respiratory Distress Syndrome Global Clinical Trials Review, H2, 2014 – visit at: http://mrr.cm/Z6R

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Healthcare, Regulatory and Reimbursement Landscape – Poland, New Report Launched

Factors such as the growing elderly population, increasing availability of affordable medicines, and transparent regulatory guidelines will provide the necessary impetus for the growth of the Polish pharmaceutical market, but a decrease in mark-up prices and the country’s stringent drug reimbursement budget will hinder growth

The pharmaceutical industry plays a key role in Poland’s healthcare system and economy. It was valued at $8.6 billion in 2013 and is projected to reach $15 billion in 2020 at a Compound Annual Growth Rate (CAGR) of 8.3% (AESGP, 2014). The pharmaceutical market had decreased from $8.8 billion in 2011 to $7.1 billion in 2012 due to the implementation of the new Reimbursement Act by Poland government in 2012, but has since partially recovered. According to the new act, the prices of the reimbursed drugs were decreased and the profit margins for wholesalers and retailers were also reduced, which impacted the pharmaceutical market negatively. The highest mark-up possible for reimbursed medicines was reduced from 9.78% in 2011 to 7% in 2012 and then to 6% in 2013. The VAT on pharmaceuticals and medical devices was 8% (ISPOR, 2013; EC, 2014). In 2013, the pharmaceutical market recovered and reached $8.6 billion due to an increase in demand for and consumption of pharmaceuticals (ISPOR, 2013).

Generic drugs have a dominant position in the pharmaceutical market. In 2012, the share of generic drugs was 66% of the pharmaceutical market, which increased from 62.2% of the total pharmaceutical market in 2011.

The prices of pharmaceuticals are lower in Poland than in other European Union (EU) member countries. These low prices enhance the affordability of pharmaceuticals, boosting the pharmaceutical market.

The cap on the reimbursement budget for drugs was decreased from 21% in 2010 to 17% in 2011 of the National Health Fund (Narodowy Fundusz Zdrowia, NFZ), so patients now have to pay more for their treatment. The NFZ administers funding and contracts providers to provide healthcare services, both for prophylaxis and therapy. The majority of resources are allotted to in-patient treatment, followed by reimbursement of medications, out-patient general care and specialized out-patient care. The value of the NFZ’s total drugs reimbursement decreased from PLN8.8 billion ($3 billion) in 2011 to PLN6.9 billion ($2.1 billion) in 2012. The decrease in the reimbursement budget would negatively affect the overall pharmaceutical market.

In Poland, the government has taken steps to increase R&D expenditure. In 2013, the expenditure on research in healthcare has been estimated at $633.5m, from $300.8m in 2008. The healthcare R&D increased at a CAGR of 22.6% over the 2008-2013 period (CSO, 2014c).

The major multi-national pharmaceutical companies in Poland are Sanofi, Novartis, GlaxoSmithKline (GSK), and Roche. Polpharma is the major local player in Poland. In Poland, imports of pharmaceuticals accounted for $4.9 billion of the total pharmaceutical market in 2013.

The medical device market was worth $2.2 billion in 2013 and is projected to reach $2.8 billion by 2020, at a projected CAGR of 3.6%. In Vitro Diagnostics (IVD) (20.3%), ophthalmic devices (18.3%), and cardiovascular devices (13.4%) were the major segments in the medical device market in 2013. With a rapidly growing elderly population and awareness of chronic diseases rising, the medical care and diagnostic markets are expected to see strong growth in the future.

Poland’s regulatory authorities provide a transparent and efficient regulatory system which facilitates the approval of pharmaceutical products and medical devices, positively influencing the market’s growth prospects

The main regulatory authority for pharmaceutical products is the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Rzeczpospolitej Polskiej (URPL)), which works under the guidance of the Ministry of Health (MoH). Obtaining Marketing Authorization (MA) for a new drug requires the execution of Good Laboratory Practice (GLP) and satisfactory compliance reviews for safety, efficacy and quality by the URPL and the MoH. It takes the URPL 210 days from the date of application to approve a new drug, and authorization is valid for five years (MPI, 2009).

The MA process for pharmaceuticals in Poland is aligned with the EU process of registration, which increases the transparency in the regulatory process.

The Agency for Health Technology Assessment (AHTA) was established as an advisory body to the MoH. AHTA opinion is said to be crucial for the MoH to give the final decision in the approval process.

Universal healthcare coverage, access to healthcare facilities and affordable pharmaceuticals are the distinguishing features of the Polish healthcare system

The healthcare system in Poland is financed mainly by health insurance contributions from state and local government budgets. The percentage of Gross Domestic Product (GDP) spent on health was estimated at 6.7% in 2013 (World Bank, 2014i).

The MoH offers universal access to healthcare, covering the entire population. The public healthcare insurance system is provided by the NFZ under the MoH. The NFZ is responsible for negotiating with regional healthcare service providers and supplying health services to the Polish population, but is not permitted to operate or own healthcare institutions. It is supervised by the Fund Council, and covers health services such as primary healthcare, out-patient specialized medical procedures, dental care, in-patient care, mental healthcare and long-term medical care.

Private health insurance is not well-developed in Poland, but is gaining popularity as a supplementary service alongside public insurance. Private insurance companies provide extra services not covered by public health insurance bodies, but at an additional cost.

The prices of pharmaceuticals are lower in Poland compared to other European Union (EU) countries, which enable increase in access of medicines to people (Simoens, 2009).

Government healthcare policies in support from the EU member countries, contributing to growing efficiency of healthcare system

The Operational Program Infrastructure and Environment, financed by the European Regional Development Fund (ERDF) and the Cohesion Fund (CF) during 2007-2013, aims at increasing Poland’s investment attractiveness.

The ERDF has allotted $105.5m for improving the quality of healthcare services and for the development of life-saving drugs. Approximately 350 healthcare projects were supported, including the construction/renovation of landing grounds for helicopters, modernization of hospital rescue wards and the purchase of modern medical equipment (MoH, 2014). The government gave priority to education. In 2010, in Poland, public spending on education was 5.2% of GDP (World Bank, 2014q).

Government initiatives and an increase in funding from the EU will drive economic growth

Poland has a stable system of democratic government, and offers a safe environment for economic activity and long-term planning due to its stable prices and consistent GDP growth. In order to attract foreign investors, the government has established a number of Special Economic Zones (SEZ) for the operation of businesses on preferential terms, providing tax exemptions, including for income and property tax. The exemption from taxes granted in the SEZ is regarded as publicly funded regional aid, which serves to boost the development of the most poorly developed regions by supporting new investments and creating new workplaces (PAIZ, 2014c).

The inflow of funds from the EU to Poland has increased in recent years and is set to grow further. In November 2013, the EU allocated $139.7 billion, including $96.2 billion as part of a cohesion policy and $36.7 billion as part of agricultural policy payments for the 2014-2020 period (MSP, 2014a). The majority of the funds will be invested in areas such as scientific research and its commercialization, the development of key road connections including motorways and expressways, business development, the creation of environmentally friendly transport systems, digitization initiatives such as broadband internet access programs and the introduction of government e-services, and for the inclusion of social and professional development activities (PAIZ, 2014a).

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Latest Guidebook for Conducting Pharma Clinical Trials in China – From Regulations to Practice (2014 Edition), New Report Launched

China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an aging population, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. By 2013, total value of drugs on Chinese healthcare market has reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. It is estimated that total value of drugs on Chinese healthcare market will be likely to be more than RMB 1450 billion by 2015, and will surpass Japan to become the second largest drug market following the United States.

The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market. Many overseas and multinational pharmaceutical manufacturers are ardently conducting clinical trials for their drugs in China to seize a larger part of such drug market. However, the Chinese approach to GCP compliance is unique, from the application and approval process, the requirements for ethics committees, sponsors and investigators to the application dossiers. To enter such a lucrative drug market, overseas and multinational pharmaceutical manufacturers and producers must have a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introdued the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep drug development lean and agile in the “post-patent-cliff” world step by step.

Target Audience:

  • Overseas pharmaceutical companies wishing to enter into the Chinese drug market.
  • Multinational pharmaceutical companies have penetrated into the Chinese drug market.
  • Companies interested in understanding the latest Chinese laws and regulations for pharmaceutical product clinical trials.
  • Senior executive officers engaging in regulatory affairs for imported drugs into Chinese lucrative drug market.
  • Senior executive officers engaging in conducting clinical trials for imported drugs in China.

Report Highlights:

  • An overview of the Chinese applicable laws and regulations for drug clinical trials.
  • An overview of organizational structure of Chinese regulatory authorities for drug clinical trials to give the direction of gateway for clinical trials of imported drugs.
  • The Chinese definitions of some basic terms used in application and approval process of drug clinical trials for drug registration, and the Chinese unique classification of drug registration, from the chemical drugs, biological products, natural medicines to traditional Chinese medicines (TCMs).
  • Chinese unique every party’s responsibilities in clinical trials for imported drug registration.
  • An entire process of application and approval procedures for clinical trials of imported drug registration.
  • The full text in English of Drug Registration Application Form for Imported Drug.
  • The practical guidance for clinical trials of imported chemical drug registration, from the general and special regulations on clinical trials for imported chemical drug registration, the requirements for data and materials of application for approval of clinical trials for imported chemical drugs to the data and materials submission of application for approval of clinical trials for imported chemical drugs to smoothly navigate complex regulatory requirements step by step.
  • The practical guidance for clinical trials of imported biological product registration, also from the general and special regulations on clinical trials for imported biological product registration, the requirements for data and materials of application for approval of clinical trials for imported biological products to the data and materials submission of application for approval of clinical trials for imported biological products to smoothly navigate complex regulatory requirements step by step.
  • The practical guidance for clinical trials of imported natural medicine and traditional Chinese medicine registration, again from the general and special regulations on clinical trials for imported natural medicine and traditional Chinese medicine registration, the requirements for data and materials of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to the data and materials submission of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to smoothly navigate complex regulatory requirements step by step.
  • A set of full text in English of Chinese laws and regulations for pharmaceutical product clinical trials.

Spanning Over 191 pages, Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)” report covering the Chinese Applicable Laws and Regulations for Drug Clinical Trials, An Overview of Chinese Authorities for Drug Clinical Trials, Knowledge Preparation before conducting Imported Drug Clinical Trials, General Regulations on Application and Approval for Clinical Trials of Imported Drug Registration, Every Party’s Responsibilities in Clinical Trials for Imported Drug Registration, Application and Approval Procedures for Clinical Trials of Imported Drug Registration, Application Form for Imported Drug Registration, Practical Guidance for Clinical Trials of Imported Chemical Drug Registration, Practical Guidance for Clinical Trials of Imported Biological Product Registration, Practical Guidance for Clinical Trials of Imported Natural Medicine and Traditional Chinese Medicine Registration, Appendices.

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Philippines’ Pharmaceutical Market Value to Reach $8 Billion by 2020, Reveals New Report

The Philippines’ pharmaceutical market value will increase from $4.3 billion in 2013 to $8 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 9.4%, thanks to the country’s high medicine prices, says research and consulting firm by Publisher.

According to the CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Philippine, the Philippines have the third largest pharma market among the countries in the Association of Southeast Asian Nations (ASEAN), just after Indonesia and Thailand.

According to Publisher’s Team, says: “Although an increasing disease burden, coupled with prevailing high pharmaceutical prices, are providing the necessary investment incentives for the healthcare market in the Philippines, limited access to healthcare facilities and governmental cuts could yet impede further growth in the future.”

Furthermore, public health insurance provider Philippine Health Insurance Corporation does not cover the country’s entire population, resulting in the majority of people being unable to afford medicines.

According to Publisher’s Team continues: “The government has taken a number of measures to control the high drug prices to very little effect, thanks to the large amount of imported therapies and the demand for costly branded drugs.”

Additionally, high spending to overcome basic economic concerns, such as poverty, dependence on imports and high external debt, have left the Philippines’ government with insufficient funds to finance the development of healthcare infrastructure, according to Publisher.

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Philippines report provides information and analysis on the healthcare, regulatory and reimbursement landscape in the Philippines. It identifies key trends in the Philippines’ healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and healthcare infrastructure.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by Publisher’s team of industry experts.

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