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CFDA Updates: China Joins ICH


ich logoICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new Observer.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is global organization, with the mission of bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

“CFDA’s joining ICH is a historic event that marks an important milestone where China’s drug and medical device industry is going to further open to the world.”, commented by Mr Lin YUAN, CDFA’s deputy minister on international collaboration affairs.

ICH is an international organization founded by drug administrators and industry associations of US, EU and Japan in 1990. The mission of ICH is to directing and coordinating drug and medtech regulations at the global level for the purpose of setting up international standards and rules for drug and medical device safety, efficacy and quality, and become the common basis for member countries’ regulatory and registration policies that should reduce the R&D and commercialization costs and push for patients to benefit from new drugs and new technologies at an earlier time. After 20+ years, the technical guidelines issued by ICH have become the foundation for drug and device regulatory and registration among all major countries around the globe.

“By joining ICH, China’s CFDA, drug and medical device industry, and research organizations are going to switch to and adopt the highest level of technical standards and guidelines in the world. China will be also actively participating in the making of these standards and enable faster China entry of foreign drugs and medical devices.” said Mr Lin YUAN. “From now on, CFDA will be able to more widely accepting international data in its regulatory and registration process.”

After joining ICH, CDFA is expected to accelerte its pace in regulatory reform that it has started.

China Med Device, LLC, specializing in providing turn-key solutions for medtech companies entry into China, brings you up to date information on CFDA. If you have any feedback, please email us atinfo@ChinaMedDevice.comor visit us

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