SFDA

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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

China FDA Announces Key Appointments and Restructuring Plan

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

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more

China Clarifies Fast Track Approval Eligibility for Novel Biologics

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

China Life Sciences Health Industry Client Briefing – February 2013 (March 11, 2013)

In This Issue: New Drug GSP Issued: Supervision on Drug Distribution to be Enhanced (China Securities Journal 2013-02-20) – February 20, 2013; China to Encourage Innovative Drug Development (Xinhua News Agency...more

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

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

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more

Chinese FDA Unveils Plan for Regulatory Reform

The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more

Chinese FDA Released Guidelines for Rx-OTC Switch

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

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