IPEC Digesting Implications of China’s Ending of Separate Excipient Approval Process

The International Pharmaceutical Excipients Council (IPEC) is working with its members and China’s Center for Drug Evaluation [CDE] to digest and manage the implications of the decision in China to switch from a separate approval process for pharmaceutical excipients to submission and review of an excipient dossier together with a drug application.

China’s FDA announced at the end of November 2017 that it was ending its separate approval process for excipients as well as APIs and drug packaging materials, and developing a platform for their review as part of drug approval.

In June 2018, CDE issued for comment a draft of its excipient registration dossier requirements. Given the short comment period, IPEC quickly pulled together a group of experts to feed comments back to CDE through its IPEC China affiliate. The comments that went in at the end of June discussed general principles and contained specific suggestions for amending language in the CDE draft.

General support was expressed for the principle of well-defined dossier documentation requirements that are internationally harmonized, and IPEC pointed to several places where CDE was requesting detailed information on excipient manufacturing, safety evaluation and drug product usage not in line with international norms.

The council highlighted China’s new membership in ICH and the importance of aligning its quality, safety and efficacy information requirements with the common format provided in ICH M4 in facilitating the objective of global harmonization. Tables mapping the M4 list of contents versus those proposed by CDE were included.

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