Regulations for Registration of Medicinal Products｜第 64 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 三 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
Applications for registration of pharmaceutical toll-manufacturing shall comply with the Regulations on Pharmaceutical Toll-Manufacturing and Contract Analysis and shall submit the following documents: 1. Application form for toll-manufacturing; 2. A photocopy of toll-manufacturing contracts, therein stating the details about the management of toll-manufacturing; 3. Application form for post-approval changes; 4. Original drug license; 5. A list of all drug licenses categorized by dosage forms, but it is exempted for toll-manufacturing only one drug license; 6. A description of each toll-manufacturing process. This requirement can be exempted, if a complete manufacturing process is commissioned to the toll-manufacturers; 7. Standard Manufacturing and Control Procedures and the amount of all components in the batch record or the batch record of the same lot as the finished product. This document can be exempted if the local manufacturers have no intention to start the manufacture yet. The certificates should be noted with the phrase: “Manufacturing is not allowed”. Manufacturers are required to submit the Standard Manufacturing and Control Procedures and obtain approval from the central competent health authority prior to production; 8. A photocopy of the contract giver’s company license; 9. A photocopy of each of the contract acceptor’s factory registration license and drug manufacturing permit. For imported drugs, those documents can be replaced with a photocopy of the acceptor’s GMP compliance certificate. If the holder of the GMP compliance certificate is not the applicant, then this document can be replaced by a letter of authorization issued by the original manufacturer or the local drug company who holds the certificate, therein specifying the approval number of the original certificate. 10. The testing specifications and methods of the finished products issued by the contract acceptor; 11. Documents of rescission with previous acceptors. Those entering into a toll-manufacturing contract for the first time can be exempted from this requirement; 12. If the imported drugs were toll-manufactured, a notification letter of post-approval changes issued by the original manufacturer and the CPP from the country of origin shall be submitted. For the imported drug substances, the CPP can be exempt. However, the relevant technical documents for changing toll-manufacture, specified in Appendix 12, are required. Drug license holder should comply with Article 46 when applying for pharmaceutical toll-manufacturing or changing the original pharmaceutical toll-manufacturing. The change of the licenses mentioned in Paragraph 1 will be processed by noting the original license rather than issuing another one. However, in situations where the assessment results show that an import permit is required to change into a manufacturing permit, a new license has to be issued. Under such circumstances, the applicant shall complete the checklist for toll-manufacturing dossiers, and provide all relevant documents, as well as the application form for drug registration and the Declaration (A). After the application is approved, the applicant shall, of their own accord, modify the labels, package inserts, outer boxes, aluminum blister foil, etc. Those materials should be submitted upon request for inspection.