Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

This post was written by Jay Yan, Mao Rong, Zack Dong, Gordon Schatz, and Katherine Yang.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during December include:

• SFDA Issues Catalogue of Class II Medical Devices Exempted from Submitting Clinical Trial Materials
• SFDA Issues Notice Concerning Circulation of Guiding Principles of Phase I Clinical Trial Management of Drugs
• SFDA Issues Notice on Soliciting Comments on Revisions of the Good Supply Practice for Pharmaceutical Products
• China Adopts Drug Safety Plan: All Drugs to be Qualified by 2015
• NDRC Issues Rules on Drug Price Parity to Prevent Disguised Price Hikes
• Guangdong Issues Drug Price Adjustment Program: 307 Western Drugs’ Price have a 22 percent Reduction in Average
• Shenzhen Public Hospitals to Revoke Drug Price Addition by the End of 2012

To read the full briefing by Reed Smith China team members, click here.

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This post was written by Jay Yan, Mao Rong, Zack Dong, Zhao Hong, Gordon Schatz, Dr. David Kan and Katherine Yang.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during November include:

• Beijing Hospital Requirements: Overuse of Antibiotics
• SFDA Issues Second Batch of Class II Medical Devices, For Which Distributors Do Not Need to Apply for Medical Devices Distribution License
• Interim Measures on Appraisal of Traditional Chinese Medicine Hospitals: Request for Comments 
• Two Pharmaceutical Companies Fined for Monopolizing Compound Reserpine API
• China to Build ADR Monitoring System
• NDRC to Investigate Ex-factory Prices of Drugs
• China Finalizes Healthcare Reform 12th FYP
• China to Launch Massive Survey on TCM Resources
• Notice Concerning Circulation of the 12th Five-year Plan of Biotechnology Development

To read the full briefing by Reed Smith China team members, click here.

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This post was written by Jay Yan, Mao Rong, Zack Dong, Zhao Hong, Gordon Schatz, Dr. David Kan and Katherine Yang.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during October include:

• SFDA Issues 2010 Annual Report on Drug Registration and Approval
• CCTV to Restrict Advertisement of Alcohol, Medical Institutions
• MOH Requires Improvement of the Reward and Penalty System for Antibacterial Drug Administration
• Draft Mental Health Law Submitted to NPC Standing Committee for First Deliberation
• SFDA: All Drugs on Market to Have E-ID by End of 2015
• SFDA Releases 3rd Batch of Illegal Drugs, Medical Devices and Health Food Advertisements in 2011
• SFDA issues Notice on Release and Delivery of GMP Certification Announcement
• SFDA issues Notice concerning Circulation of the Administrative Measures on Drug Supervision in Medical Institutions
• Detailed Summary of SFDA 2010 Annual Report on Drug Registration and Approval

To read the full briefing by Reed Smith China team members, click here.

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This post was written by Jay Yan, Mao Rong, Zack Dong, Zhao Hong, and Gordon Schatz.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during September include:

• SFDA Circulates Guidelines for Monitoring Adverse Events Involving Medical Devices
• SFDA Issues Letter Soliciting Public Comments on Communication Methods for Responsible Food and Drug Safety
• Swiss Drugmaker Novartis Expands in China
• China to Divide Emergency Patients into Four Classes for Medical Treatment
• China’s Biopharmaceutical Industry to Accelerate Internationalization
• MOH surveys Clinical Application of Antimicrobials
• Medtronic Opens Orthopedic R&D Center with Weigao
• DHL Establishes Second Life Science and Health Care Logistics Center in Beijing

To read the full briefing by Reed Smith China team members, click here.

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This post was written by Jay Yan, Mao Rong, Gordon Schatz and Abraham Sorock.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Food & Health Care Industries.
Some important developments during June include:

• Chinese drug company to build production and training center in U.S.
• Drug company challenged for environmental contamination in China
• China's national biomedical plan to be released soon
• Issuance of administrative measures for device recalls
• Designation of four professional associations to examine Class III medical technology
• Extension of Drug GMP certificates
• Recall of an antibiotic

To read the full briefing by Reed Smith China team members, click here.

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The Food and Drug Law Institute (FDLI) has an interesting upcoming conference on June 13-14 in Beijing, China that will address current legal, regulatory and economic issues regarding food, cosmetics, dietary supplements, pharmaceuticals and medical devices in China and the United States. Speakers are top government officials and internationally renowned experts who will discuss the issues in both countries.  They include Dr. Margaret A. Hamburg (Commissioner of Food and Drugs, US Food and Drug Administration), Wu Zhen (Deputy Commissioner of China's State Food and Drug Administration), Ralph Tyler (Chief Counsel, US Food and Drug Administration), Rosemary Gallant (Principal Commercial Officer Beijing, US Embassy Beijing, Commercial Section), Ding Jianhua (Deputy Director-General, Department of International Cooperation, SFDA), Wang Lanming (Supervisor-General, Department of Medical Devices Supervision, SFDA), Lin Wei (Deputy Director-General, Bureau of Import-Export Food Safety, AQSIQ) and Jinjing Zhang (Deputy Director General, Department of Food Licensing, SFDA).  Reed Smith partner Gordon Schatz will be speaking on the panel "Innovation and Access: Key Success Factors in China."

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China's long-awaited Tort Liability Law, passed on December 26, 2009 by the Standing Committee of the National People’s Congress of China, will take effect on July 1, 2010. The law, which serves to provide a stronger basis for the development of tort law and practice in China, offers standard guidance on issues ranging from product liability, environmental pollution, medical malpractice to employee-related liabilities. For example, prior to the enactment of the law, defective product recall obligations were only applied to a limited number of products, including medicine, food, toys and automotive products. The new law, however, expands the recall system to cover all products manufactured or sold in China.

Reed Smith Beijing Counsel Mao Rong and Michael H. Dardzinski and Consultant Joyce Sun recently drafted a brief summary of China's new tort law provisions regarding product liability, medical-related damages and environmental pollution. Read the full summary here.

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