The Center for Medical Device Evaluation (the “CMDE”) recently clarified its requirements on supplementary information for medical device evaluation in connection with the registration of domestic Class III medical devices...more
5/28/2013
- China FDA Medical Devices Supplemental Information
Following its recent re-elevation to the ministry level and the appointment of a new Commissioner in March, Mr. Yong Zhang, former Director of the Food Safety Office under the State Council of China, the China Food and Drug...more
5/21/2013
- Administrative Appointments China FDA Restructuring
The China Food and Drug Administration (previously known as the State Food and Drug Administration) (the “CFDA”) has published drafts of two tentative measures, Fast Track Approval Process of Innovative Medical Devices and...more
3/26/2013
- Approval China Medical Devices
The Chinese State Food and Drug Administration (“SFDA”) created a fast track review and approval process for novel drugs in its Drug Registration Rules issued in 2007. The fast track approval process is available for (1)...more
3/13/2013
- Biologics China Pharmaceutical Prescription Drugs SFDA
To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more
3/4/2013
- China Drug Manufacturers Licenses Pharmaceutical SFDA
The State Food and Drug Administration (“SFDA”) recently announced a set of technical guidelines for switching prescription drugs to over-the-counter drugs (“Rx-OTC Switch Guidelines”). The Rx-OTC Switch Guidelines include...more
12/5/2012
- Rx-OTC Switch Guidelines SFDA
The State Food and Drug Administration (“SFDA”) in China published a draft of the Tentative Measures for the Administration of the Registration of Re-Packaging In-Vitro Devices (IVDs) (“Draft Measures”) on November 2 for...more
11/15/2012
