China Pharmaceutical Industry

News & Analysis as of

Your Daily Dose of Financial News

A new trading link dropping next week will give international investors access to more than 800 stocks listed on China’s Shenzhen stock market, the boom/bust venue best known for its “rampant speculation”....more

Top Ten International Anti-Corruption Developments for October 2016

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

Your Daily Dose of Financial News

The CFTC’s reportedly investigating the interest rate swap activities of Citigroup and others. Swaps allow companies to “hedge against a rise or fall in interest rates on the debt that they issue or hold, with banks usually...more

Top Ten International Anti-Corruption Developments for September 2016

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 tightens regulations for vaccine distribution and issues new product registration measures

In the wake of a case of illegal trading of vaccines that implicated more than 300 people, ranging from businesses operating without proper licenses to hospital personnel, China's State Council has released amendments to the...more

GSK Settles SEC FCPA Case for $20 Million

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

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

Donations and Grants in China: Compliance Controls Beyond T&E

While travel and entertainment expenses have presented significant compliance challenges for life sciences companies operating in China, donations and grants can also pose notable compliance risks. China’s escalated...more

Second Circuit: “C” is for Comity; Price Fixing Judgement Against Chinese Vitamin C Sellers Reversed

Last week, in In re Vitamin C Antitrust Litigation, the US Court of Appeals for the Second Circuit (“Second Circuit”) vacated a $147 million jury award against Chinese vitamin C sellers Hebei Welcome Pharmaceutical Co. and...more

Top Ten International Anti-Corruption Developments for August 2016

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

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Your daily dose of financial news - The Brief - 9.2.16

Turns out that the Anbang Insurance Group—the powerful Chinese insurer that’s made plenty of Brief appearances for its massive bids on US hotels, among others—really does live up to its air of mystery, with many of its...more

China FDA Clarifies Legal Consequences of Clinical Trial Data Inspections

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. On...more

Your daily dose of financial news - The Brief – 8.23.16

The 2d Circuit has refused the DOJ’s motion for reconsideration of the panel’s May decision overturning a jury verdict and accompanying $1.27 billion fine against Bank of America over its “Hustle” mortgage generation program....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

CFDA Solicits Comments on Drug Registration Rules

The China Food and Drug Administration (“CFDA”) recently published long-awaited and comprehensive revisions (“Revisions”) to the Drug Registration Rules (“DRR”). The Revisions are now open to public comments until August 26,...more

Top Ten International Anti-Corruption Developments for June 2016

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

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

Your daily dose of financial news - The Brief – 6.16.16

As expected, the Fed announced yesterday that it was holding current interest rates steady and would be slow to push rates up while the economy tiptoes toward stability. Much more from Chair Yellen and economists’ reaction...more

China Announces a Detailed Pilot Plan for the Marketing Authorization Holder System for Drugs in Selected Regions

China’s State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System (“MAH”) for drugs in 10 provinces in China (the “Plan”). The three-year pilot program was initiated in...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

Q1 2016 IPO Market Review

The first quarter of 2016 produced a meager eight IPOs with gross proceeds of $667 million. Only once over the prior 12 years has the first quarter produced a lower tally—there were only two new offerings in the glum...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Ken Adam and the Imagination of Reality – Corporate Governance

Ken Adam died earlier this month. If you are anything close to a James Bond aficionado, his name is well known to you for his creation of the fabulous sets on all the movies from Dr. No to Moonraker. I still marvel at the...more

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