News & Analysis as of

Medical Devices Pharmaceutical Industry China

CFDA’s New Draft Policy Introduces the Chinese Version of Patent Linkage

by Allen & Overy LLP on

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more

China FDA Calls for Comments on Key Policy Proposals

by Ropes & Gray LLP on

On May 11-12, 2017, the China FDA (CFDA) issued four new draft policies for public comments, proposing further reforms in the current drug and medical device regulatory regime. The four draft policies aim to accelerate the...more

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

GSK Settles SEC FCPA Case for $20 Million

by Michael Volkov on

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

The Oscar Meyer Wiener Theme and Revisiting GSK in China

by Thomas Fox on

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

Business Litigation Report - July 2016

Article: Increase in Vertical Price Restraint Enforcement in China - In recent months, Chinese anti-monopoly enforcement actions scrutinizing and penalizing pricing-related issues have noticeably increased. A growing...more

Top Ten International Anti-Corruption Developments for June 2016

by Morrison & Foerster LLP on

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

China FDA Solicits Comments on Priority Review Designation Procedure for Devices

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently proposed a draft circular to address the priority review designation issue for medical devices, namely the Circular Regarding Soliciting Comments Regarding Priority...more

China FDA Announces Good Clinical Practices for Medical Devices

by Ropes & Gray LLP on

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

Drug and Medical Device Corruption Risks in China

by Michael Volkov on

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

Alert: China Piloting Drug Marketing Authorization Holder System

by Cooley LLP on

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

by Michael Volkov on

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

China’s State Council Announces Reform on the Drug and Device Approval System

by Ropes & Gray LLP on

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

China Tightens Advertising Rules for Life Sciences Companies

by Ropes & Gray LLP on

This year China’s Advertising Law will see its first amendment in two decades. The amendment, which will be implemented on September 1, 2015, reflects the central government’s efforts to strengthen consumer protection and to...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

by K&L Gates LLP on

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

China Introduces New Health Care Sector Anti-Corruption Regulations

by Benesch on

China Introduces New Health Care Sector Anti-Corruption Regulations As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and Family Planning...more

What Hath GSK Wrought? More Compliance Lessons From China

by Thomas Fox on

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

Ten Required Steps To Ensure Effective Compliance Programs By Pharmaceutical And Medical Device Companies (Part III Of III)

by Michael Volkov on

In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more

Astros Swept Again – Is A China Sweep Coming Next?

by Thomas Fox on

What is a sweep? It is certainly a well-known and relevant term in the sporting world....more

Pharmaceutical And Medical Device Companies: Taking It On The Chin (Part II Of III)

by Michael Volkov on

As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring. ...more

Bad News For The Drug And Device Industries: Glaxo’s Systemic Breakdown In China (Part I Of III)

by Michael Volkov on

Mark Twain, one of my favorite authors, always said it best – “Do the right thing. It will gratify some people and astonish the rest.” - For drug and device companies, Mark Twain’s observation is becoming the industry...more

Chinese Detain Pharmaceutical Company Managers in Economic Crime Probe

This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential “economic crimes.” The...more

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Reed Smith on

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

by Reed Smith on

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more

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