CFDA Updates

November 7, 2017

China’s State Council: Official Opinions On Deepening the Review and Approval Policies Reform and Encouraging Drug And Medical Device Innovations

On October 8, in a government news conference in Beijing, the State Council issued the “Opinion on Encouraging the Innovation of Drugs and Medical Devices by Deepening the Reform of […]
November 2, 2017

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, […]
October 19, 2017

China to Speed Up Approvals Of New Drugs and Medical Devices By Accepting Overseas Trial Data

China is looking to speed up approvals for new drugs and devices and plans to accept data from clinical trials carried out overseas, a potential huge benefit  for both international […]
October 10, 2017

CFDA Gives Approval To China’s First Domestically Produced Pacemaker By a China-Overseas Joint Venture

China Approves the Rega™ Line of Pacemakers CFDA said YES to the Rega™ line of pacemakers, China’s first domestically manufactured pacemakers that meet international standards. This product is manufactured in […]
October 6, 2017

CFDA Issued 7 New Technical Review Guidelines

CFDA has issued 7 new guidelines from September 13rd to September 21st. Even though they are called guidelines, once they are released, you are expected to comply with them whether your […]