China’s Center for Drug Evaluation (CDE) has unveiled a draft set of “Application Material Requirements” aimed at streamlining the market approval process for drugs that are either listed overseas and subsequently transferred to domestic production or are therapeutic biologic products. The draft, which is open for public consultation for a period of one month, provides clarity on the technical specifications required for market approval filings under the current registration classification of Class 3.4.
The document impacts the current “M4: Human Drugs Registration Common Technical Document (CTD)” framework, detailing the specific requirements for the five modules of application materials. It outlines the overall principles and proposes simplified application prerequisites for the application of biological products using such application paths and classified registration.
Furthermore, the document stipulates that only drugs with regular approvals, not conditional approvals, are eligible for domestic production filings. It also states that drugs within the same group, under the same quality management system, and meeting relevant technical requirements, can be used as originator reference drugs.- Fineline.com
