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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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