China Requirements for MAH Holders that Outsource Manufacturing in China Becoming Stricter

According to China’s Drug Administration Law, Chinese Marketing Authorization Holders (MAHs) have the right to outsource drug manufacturing to contract manufacturers. Recently, China issued a draft notice to MAHs to increase the quality of drugs made by third parties. Specifically, provincial NMPA offices will need to agree to this outsourced activity, oversee GMP, and meet other requirements.

MAHs will need to have set up an operation with enough qualified people to meet QMS requirements for the drug subcontractor. Additionally, MAH drug representatives will need to do annual face-to-face audits of drug material suppliers. A quality agreement between the MAH and the contract manufacturer will require sampling of material batches, inspections of APIs, excipients, and packaging materials.

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.

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