As drug registration applications grow dramatically in China, so will the CDE audits of drug manufacturing facilities according to the Center for Drug Evaluation (CDE). Earlier this year, the CDE set up a 3-tier system for audits of drug factories including low, medium, and high risk. Audits will primarily focus on high-risk facilities for all biologics, reconfigured new drugs, and new chemical drugs. China GMP compliance will be required as well as the quality of the research data. Given limited auditing resources, the CDE will do audits at all high-risk factories, and a lot less inspection on medium to low-risk situations. If during the technical review, there are quality issues or inaccurate information, then the factory will be considered high risk for an additional 5 years. In addition, the accuracy and adherence to the GCP will also be more strictly watched for both CROs and drug companies.
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.
Source used in the article: https://globalforum.diaglobal.org/issue/february-2023/chinas-nmpa-takes-action-to-participate-in-pic-s/