Regulations for Registration of Medicinal Products｜第 9 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
The testing specifications, methods and certificate of analysis of raw materials mentioned in this Chapter refer to those for active pharmaceutical ingredients (API) and every substance of the formula (including auxiliary materials and coloring agents added during the manufacturing process). The testing specifications, methods and certificate of analysis of raw materials said in the preceding paragraph should comply with the following regulations: 1.If using a pharmacopoeia as a reference for raw materials, the applicant should indicate the pharmacopoeia’s titles, publication year and editions. The pharmacopoeia is restricted to the Chinese Pharmacopoeia, pharmacopoeias published by the A10 countries, or pharmacopoeias approved by the central health competent authority. The cited edition should be the latest from the date of application. This requirement also applies to any post-approval change of raw materials except excipients. 2. New chemical entities (NCE) are subject to the regulations set by the manufacturers. 3. The reference standards for tests should be indicated whether they are Primary Standard or Working Standard. For Primary Standard, the source should be specified. For Working Standard, the source, batch number, labelled content (or potency), testing specifications, certificate of analysis and calibration procedures should be specified. 4. For coloring agents, testing specifications and methods should be indicated. Testing specifications are not required for aromatics. 5. The certificate of analysis justifying every formulation substance should be the certificates about the substances of the same lot as the finished products. 6. Raw materials should be tested against each specification item. Documented operational procedures of items exempted from tests should be submitted, along with the certificates of analysis of the batch subject to full tests. 7. If test results are in numerical figures, then keep the original data in the document; if the test is a comparison with reference standard, then use “pass” to indicate a satisfactory result.