The National Medical Products Administration (NMPA) recently issued the Principles and Protocols for Exploratory Research in Drug Sampling Inspections (hereinafter referred to as the "Document").
The Document primarily applies to exploratory research conducted as per the protocols during drug sampling inspections, as well as the related analysis based on inspection and exploratory research outcomes to assess the quality status of sampled drugs. The Document specifies that, except for special regulatory requirements, the selection of drugs for exploratory research should refer to Article 11 of the Administrative Measures for Drug Quality Sampling and Inspection, and that drug regulatory authorities organizing sampling inspections should study the types of drugs intended for exploratory research, including determining the minimum number of sampled batches, processes subject to sampling, coverage rates of enterprises, and coverage rates of drug approval document IDs. The Document explicitly states that exploratory research should focus on key factors affecting drug quality, such as major or significant defects existing in formulation processes or current standards and quality, and issues found in standards compliance inspections. In general, it should not repeat the content covered in pre-clinical research and Phase I clinical trials conducted for new drugs.