In mid-February, China’s Center of Drug Evaluation (CDE) under the NMPA promulgated two new guidelines. The first guideline was titled – The Guideline for Acceptance and Review of Chemical Drug Registration (trial) – which will begin on March 10 of this year. This new chemical drug guideline includes a new specific direction on document requirements, acceptance benchmarks, important review points, etc. Updates were also made for reference drug information, clinical trial data, a self-inspection checklist, etc.
On the same date, and beginning also on March 10, the CDE issued its second guideline titled – The Guideline for Acceptance and Review of Biological Product Registration (draft). This new biological guideline discusses the registration of biological products, as well as therapeutic and preventative biologics, and IVD reagents that are considered biologics. Other updates include new electronic submission requirements, various routes for emerging therapies, enhanced manufacturing control requirements, etc. The goal of these two draft guidelines is to more closely align with international standards, simplify the drug registration process in China, and explain how to better utilize electronic submissions, among others.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.