From July 2 to 3, 2025 “Training Course on Post-approval Change Management of Chemical Drugs (7th Session)” hosted by National Medical Products Administration Institute of Executive Development (NMPAIED) was successfully held in Guangzhou. The training attracted hundreds of professionals from drug regulatory agencies, pharmaceutical companies and R&D institutes across the country, and provided authoritative guidance to the industry through in-depth exchanges on the scientific management, regulatory requirements and practical cases of post-approval changes of chemical drugs. Dr. Yinbo Li, a senior drug registration expert, brought to the participants in this training a wonderful sharing on two topics: “Preparation of Change Information and Communication Strategy of Listed Chemical Drugs” and “Statistical Analysis, Case Sharing and Implementation Strategy of Recent Changes of Listed Chemical APIs in China”, focusing on the following contents:
1) Preparation of post-approval change application dossier of drug products and APIs:
Show online filling in the supplementary application form, the latest supplementary application document structure with a large number of examples, and take domestic traditional Chinese medicine supplementary application, imported preparation medium change filing, imported API supplementary application as examples to explain the preparation of different types of application dossier and document preparation tips.
2) Sharing of experience in the preparation and submission of e-application dossier in China:
Share the experience in the preparation of e-application dossier of listed drugs, as well as the advantages, disadvantages and precautions of network transmission and CD-ROM submission according to the requirements of the latest announcement of CDE on July 2.
3) Suggestions on communication strategies for the study of changes in listed drugs:
Analyze the ideas of the study of changes in listed drugs, introduce the communication ways of CDE, the Centre of the Greater Bay Area, and the Beijing Municipal Bureau, so as to guide companies to pay more attention to the communication with authorities from the perspectives of pharmaceutical companies and drug regulatory authorities.
4) Analysis of recent change filing data of listed drugs and APIs in China:
In about 2,000 retrievable change records from October 2024 to June 2025, analyze domestic and foreign pharmaceutical companies' change requests, share good change cases, and present the experience of several cases in which the filings were withdrawn, and the supplemental applications were not approved.
Dr. Li's courses are presented in a way that combines theory with cases, making them easy to understand, and are highly praised by the participants.
Post-approval change management is a critical part of the whole life cycle of drugs and a key capability for high-quality development of enterprises. The training provides valuable experience for the industry through policy interpretation, technical guidance and case sharing. In the future, we will continue to pay attention to the industry's needs and build more professional exchange platforms to help enterprises improve their compliance level and promote industrial innovation and upgrading.
