CFDA

News & Analysis as of

Using Social Media to Fight Graft and Governmental Mismanagement

It's not easy to be a whistleblower. It's even harder to be a whistleblower if you are a Chinese high-level official calling out another high-level official, and doing it on social media. Thousands of Chinese swarmed...more

China Unveils Detailed Rules to Implement the Core Device Regulation

The amended Regulation for the Supervision and Administration of Medical Devices (the “Regulation,” also known as the State Council Order No. 650), which came into force on June 1, 2014, set the new framework for China’s...more

Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No....

China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the “New Regulation”). The State Council...more

China Introduces Major Changes to Medical Device Regulations

On March 31, 2014, China’s State Council released the amended Regulations on the Supervision and Administration of Medical Devices (the “Regulations”), effective as of June 1, 2014. A series of implementing rules are expected...more

China Tightens Supervision and Enforcement in the Medical Device Sector

On March 13, 2014, the China Food and Drug Administration (the “CFDA”) announced an action plan titled “Rectifications of Five Common Types of Noncompliance Concerning Medical Devices” (the “Five Rectifications Campaign”). A...more

China Solicits Comments on Good Supply Practices for Medical Devices

The China Food and Drug Administration recently published a draft regulation setting minimum standards for medical device distribution. The regulation sets forth requirements for procurement, delivery acceptance, storage,...more

China Releases Fast Track Approval Process for Innovative Medical Devices

On February 7, 2014, the China Food and Drug Administration (“CFDA”) promulgated a notice titled The Fast Track Approval Process for Innovative Medical Device (Tentative), effective as of March 1, 2014. Unlike the draft...more

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

In late December, China’s National Health and Family Planning Commission ("NHFPC"), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013...more

China Expects Major Changes in Drug Registration and Contract Manufacturing Rules

The China Food and Drug Administration (“CFDA”) recently announced several draft rules, most notably, the Draft Amendment of the Provisions for Drug Registration (also known as the Drug Registration Rules, DRR) and the Draft...more

China Releases Vaccine Good Clinical Practices

On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more

China Tightens Food Safety Administration

The Chinese State Council recently announced the draft amendment of the Food Safety Law (“Draft Amendment”) for public comments through November 29, 2013. A high priority initiative on the Chinese government’s agenda to...more

China Solicits Comments on Post-Market Study Guidelines

The Center for Drug Evaluation (“CDE”) in China recently published the draft Guidelines for the Administration of Post-Market Studies on Chemical Drugs and Therapeutic Biologics (“Draft Guidelines”) for public comments...more

China Solicits Comments on New Drug Technical Review Guidelines

The Center of Drug Evaluation (“CDE”) of the China Food and Drug Administration (“CFDA”) recently announced the Draft Guidelines for Clinical Evaluation of NDA/BLA Applications (“Draft Technical Review Guidelines”) for public...more

United States v. Vilar: new limits on extraterritorial securities enforcement

In United States v. Vilar, the Second Circuit Court of Appeals has offered another data point in the federal courts’ ongoing efforts to define the extraterritorial reach of the federal securities laws. Although we...more

China Life Sciences Health Industry Client Briefing – May/June 2013 (July 12, 2013)

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - .. Medical Devices Regulations and News - Provincial FDAs to Approve Certain Changes to Medical Device Registration Certificates – June 21,...more

China Business, Trade and Competition Bulletin - June 2013: China Renames Regulatory Agency: What’s in Store for the Cosmetics...

In March 2013, the National People’s Congress of China formally changed the name of the State Food and Drug Administration (SFDA) to the China Food and Drug Administration (CFDA), elevating it back to a ministerial-level...more

16 Results
|
View per page
Page: of 1