China Pharmaceutical Industry

News & Analysis as of

Alert: China Piloting Drug Marketing Authorization Holder System

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

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

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

SEC, Bristol-Myers Settle FCPA Charges

FCPA procedures, internal controls and travel, entertainment and gifts were at the center of the SEC’s latest FCPA action. The action names as a Respondent Bristol-Myers Squibb Company and focuses on its efforts to sell...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

Manufacturing Outlook - July 2015 - 2015 Q3

Welcome to the 2015q3 Manufacturing Outlook report in partnership with DLA Piper. It has been an eventful summer in the world economy; while not quite four seasons in one day, we’ve seen the future of the eurozone on the...more

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

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 FDA Solicits Comments on Resolving the Backlog of Drug Applications

The China Food and Drug Administration (“CFDA”) recently published a draft circular to address the backlog of drug applications. The Circular Regarding Several Draft Policy Opinions to Accelerate the Resolution of the Backlog...more

China Tightens Advertising Rules for Life Sciences Companies

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

Rejection of Gilead Patent Raises Issues for Companies Seeking Pharmaceutical Patent Protection in China

Chinese patent prosecution recently made worldwide headlines when the press announced that the Chinese Patent Office (SIPO) rejected a Gilead Sovaldi prodrug patent. Sovaldi (sofosbuvir) is a breakthrough drug used to treat...more

China Removes Price Ceilings from Most Drugs

Chinese consumers have long complained about high drug prices. To address this problem, in 2000 the Chinese government adopted a price ceiling system for drugs. At that time, the medical insurance system and the drug bidding...more

NDRC Issued Opinions and Notice on Drug Price Reform

On May 4, 2015, the National Development and Reform Commission (“NDRC”) and seven agencies including the National Health and Family Planning Commission and the Ministry of Human Resources and Social Security jointly published...more

China Regulatory Enforcement Quarterly - Q1 – 2015 |

Inside This Issue: - Executive Summary - PRC Legal and Regulatory Updates - Major Enforcement News - China Communist Party Titles 101 - AIC Penalties Increase Risk of Dual Enforcement Actions - Frequently Asked...more

China Liberalizes Drug Pricing Control

Beginning June 1, 2015, the vast majority drugs in China, except for narcotic and Type 1 psychotropic drugs, will be free from government-set pricing. This reform on drug pricing policy was announced by the central pricing...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Chinese Legislature Adopts Amendments to Drug Administration Law

China’s top legislature, the Standing Committee of National People’s Congress, recently approved the amendments (the “Amendments”) to the Drug Administration Law. The Amendments, effective as of April 24, 2015, cover the...more

The Ropes Recap: Mergers & Acquisitions Law News - First Quarter 2015

In this issue: - News from the Courts - Chancery Court Denies Enforcement of Drag-Along Right in Transaction Where Notice to Minority Stockholders Improperly Provided After Majority Stockholder Approval...more

China Announces Final Biosimilars Guideline

The Center for Drug Evaluation (the “CDE”) under the China Food and Drug Administration published final biosimilars guidance on February 28 with immediate effect. Officially titled the Technical Guideline for the Research,...more

China Announces Revised Good Clinical Practices for Public Comments

The China Food and Drug Administration (“CFDA”) recently released its proposed revisions to Good Clinical Practices (“GCP”) for pharmaceutical clinical studies for public comments. The proposed revisions, if eventually...more

China Regulatory Enforcement Quarterly - Noteworthy developments and insights from the fourth quarter of 2014

In This Issue: - Executive Summary - PRC Legal and Regulatory Updates - Major Enforcement News - The Pharmaceutical Blacklist: A Look Back - After One Year - PRC Anti-Corruption 101 - Frequently Asked...more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Back in the game: The rise of US M&A

US M&A is bouncing back - After a tough few years, acquisitions in the United States have seen a remarkable resurgence - The first half of 2014 saw a great dealmaking revival in the United States. Deal values...more

Red Notice Newsletter - October 2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

Leading Pharmaceutical Company Fined $491 Million for Bribery

A Chinese court convicted a large British pharmaceutical company of corruption and bribery while doing business in China. As a result, the company must pay a record-breaking fine of $491 million while each of the implicated...more

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