Regulations for Registration of Medicinal Products Article 45

The stability studies, required for the application of post-approval changes, should comply with the following regulations of execution and data submission:1.For any changes in drugs subject to the submission of the stability study report, the applicant needs to conduct 6-month accelerated stability studies on a batch of changed products, as well as a long-term stability study that tests through the expiration date. Data of at least 3-month accelerated stability studies should be submitted when applying for post-approval changes. The manufacturer should retain the documentation of operational details and test figures of other accelerated studies and long-term studies.2.For changes in drug expiration date, manufacturers should conduct long-term stability studies on 3 marketed batches of drugs that tests through the expiration date, and analyze the results. For drugs applied for registration before 1 January 2001, manufacturers can decide whether to conduct storage tests or long-term tests based on the Guidelines on Stability Studies. Manufacturers should retain historical documentations of the operational details and original testing results and other related data for inspection; however the applications for post-approval expiration date changes would not be required.For the documents that should be retained by manufacturers as mentioned above, the applicant has the obligation to provide relevant information upon the central health competent authority’s request. If the authority finds any discrepancy in the information, the applicant has to recall all products from the market and receive punishment according to the related regulations in the Act.