《药品注册检验工作程序和技术要求规范》（2025年修订版）政策解读

Group 1: Purpose and Significance of the Revision - The revision of the "Regulations" aims to further standardize drug registration inspection work, effectively support drug review and approval, and serve the pharmaceutical industry [1] - The revision is in response to new policies and requirements aimed at fostering high-quality development in the pharmaceutical industry, as outlined in the State Council's opinions issued in December 2024 [1] Group 2: Revision Approach - The revision process adopted a problem-oriented approach, collecting nearly 700 feedbacks from various stakeholders, including regulatory bodies and industry associations, to incorporate reasonable suggestions into specific provisions [2] - The revision maintains effective content from the trial version while modifying or removing outdated elements to better align with actual requirements [2] - The revised version introduces measures such as allowing supplementary applications for pre-registration inspections and compressing inspection timelines to enhance efficiency [2] Group 3: Measures to Facilitate Enterprises - The scope of pre-registration inspections has been expanded to include supplementary applications, improving the efficiency of review and approval for post-marketing changes [3] - The required sample quantity for registration inspections has been reduced from three times the inspection amount to two times, and for rare disease drugs, from nine times to two times [3] - Inspection timelines have been shortened, with priority review drugs seeing a reduction of 10 working days, and for urgently needed rare disease drugs, a reduction of 20 working days [3] Group 4: Changes in Sample Requirements - The packaging specifications for samples have been optimized, allowing for submission of either overseas market packaging or proposed domestic market packaging [4] - The requirements for the remaining validity period of samples have been relaxed, allowing for negotiation with inspection agencies if the remaining validity does not meet the standard [4] - The process for filing standard material raw materials has been streamlined, with online submission and a clear timeline of five working days for issuing filing certificates [4] Group 5: Pre-registration Inspection Policy Utilization - The revised regulations clarify the requirements for pre-registration inspections related to supplementary applications, encouraging applicants to assess their submissions against technical guidelines [6] - Applicants are encouraged to utilize pre-registration inspections, especially for priority review drugs, to ensure timely completion of inspection reports [6] Group 6: Changes in Inspection Timelines - The trial version set the inspection timeline for individual sample inspections at 60 days and for combined standard reviews at 90 days, which have now been shortened for priority review drugs [7] - For urgently needed rare disease drugs, the inspection timeline has been reduced by 20 working days, enhancing the speed of the review process [7] Group 7: Changes in Sample Quantity for Registration Inspection - The sample quantity for registration inspection has been reduced from three times the required amount to two times, with specific adjustments for rare disease drugs to alleviate the burden on enterprises [8] - The revised regulations allow for a single batch of samples for rare disease drugs, significantly reducing the cost and encouraging research and development [8] Group 8: Use of Initial Inspection Samples - The revised regulations allow for the use of initial inspection samples if they meet the necessary requirements, reducing the burden on applicants for resampling [9] Group 9: Changes in Sample Submission Timelines - The revised regulations no longer impose a strict 30-working-day timeline for sample submission after receiving inspection notifications, allowing for more flexibility [10][11]