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China and U.S. Agencies Met to Further Their Drug Medical Device Regulatory Cooperation


China and U.S. Agencies Met to Further  Their Drug Medical Device Regulatory Cooperation

Recently, CFDA’s International Cooperation Bureau in conjunction with the Center for Drug Evaluation, the Verification Center, and other CFDA department heads met with visiting U.S. FDA Representatives, Office of International Programs (OIP), Senior Advisor, Carl Sciacchitano, the Associate Commissioner for IP, Senior Advisor, Leigh Verbois, Director for the OIP’s China Office, Julio Salazar, and Deputy Director, Irene Chan.

The two sides held a special discussion on the intention and plan for continued cooperation in the field of drug supervision between China and the United States. The two sides agreed that in recent years, China and the United States food and drug regulatory departments have carried out fruitful cooperation on the basis of the cooperation documents (“on drugs, medical devices security agreement” and “on the implementation schedule about regulators related cooperation mechanisms”). The two sides agreed that the future will continue to deepen cooperation on the aspects of drug approval and drug inspection pragmatic exchanges, promote the establishment of a modern drug approval system and inspection system, and open a new chapter of drug regulatory cooperation between China and the U.S.

China Med Device believes continued collaboration between the FDA and the CFDA should certainly help U.S. and other overseas medical device companies with their efforts to enter the increasingly important Chinese market.

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