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 Areta L. Kupchyk and Kevin M. Madagan.

On July 14, 2011, the Food and Drug Administration (“FDA”) proposed to permit wholesale distributors to document the chain of custody (also known as a drug “pedigree”) of prescription drug products only back to the last authorized distributor of record (“ADR”), instead of all the way back to the manufacturer. As explained in our client alert, FDA’s proposal (if implemented) will not impact the current operations of wholesale drug distributors, and it does absolutely nothing to address a more pressing problem facing the industry – an increasingly complex patchwork of diverse state pedigree requirements.

To read the full alert, 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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This post was written by Joseph W. Metro and  David E. Dopf .

The New Jersey Department of Human Services (“Department”) has sent letters to numerous pharmaceutical manufacturers demanding rebate payments under the Work First New Jersey General Public Assistance/Medicare Part D Wraparound Drug Rebate Program (“GA Rebate Program”). The Department is seeking to collect payments from manufacturers that have chosen not to participate in the GA Rebate Program and thus never entered into a GA Rebate Program agreement with the Department (“Rebate Agreement”). In addition, for some manufacturers that have entered into Rebate Agreements, the Department is now seeking payments for time periods prior to the effective dates of those Rebate Agreements.

The Department’s demand letters have uniformly provided the manufacturers with the option of requesting, within twenty (20) days from their receipt of the letter, either a pre-hearing conference for purposes of trying to resolve the payment dispute or a formal hearing before the New Jersey Office of Administrative Law (“OAL”). Manufacturers choosing to pursue a pre-hearing conference can still request a hearing before the OAL within twenty (20) days from the date of the pre-hearing conference if the dispute is not resolved.

We believe there are very strong arguments in support of the position that a manufacturer cannot be liable for payments under the GA Rebate Program in the absence of a Rebate Agreement covering the time period for which the payments relate. Please contact Joe Metro or David Dopf if you have any questions regarding the Department’s actions or would like assistance challenging the Department’s demand for payment.
 

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