Regulations for Registration of Medicinal Products｜第 54 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
The following documents are required for changes in indications: 1.Application form for post-approval changes; 2.The original copy of drug license; 3.Two copies of complete clinical trial report or related references of the claimed indications; 4.For locally manufactured drugs, an official reference book recording the new indications is needed. For imported drugs, approval of new indications issued by the central health competent authority of the country of origin and authenticated by the R.O.C foreign affairs offices is needed. If these documents are not available at the time of filing, the applicant shall provide the required documents before approval. The authentication requirement is waived for documents issued by A10 countries or the EMA. The above-mentioned documents can be replaced with the approval information on the A10 countries highest health competent authority or the EMA’s official website and approval letter of new indications issued by the of A10 countries or the EMA; 5.An original approved copy of the form with labels and package inserts attached along with the central health competent authority’s stamp on the seams. The above-mentioned documents can be exempted when the original copy was approved via the electronic submission platform; 6.Two actual packaging materials (or color photos) or drafts of package inserts, labels, outer boxes, and aluminum blister foil sheets. For imported drugs, two copies of package inserts in the original foreign language are needed; 7.For imported drugs, the notification letter of post-approval changes issued by the original manufacturer is needed. 8.The comparison table of changes of package inserts or drafts of package inserts with tracking revisions and comments. If there is evidence from clinical trials conducted in Taiwan to justify that the drug is effective and safe for the new indication, then the first applicant applying for the addition of the new indication can be exempt from the requirement described in Item 4 in the preceding paragraph. The first applicant of the addition of a new indication (including changes of indications and addition of indications) may decide whether or not to conduct local clinical trials. If a local clinical trial has been conducted by the first applicant to justify the drug is effective and safe for the new indication, then during the following 5 years, other applications filed by other manufacturers of drugs with the same ingredients, dosage form and dose, either for licensing the new indication or for extending an existing license, should also provide local clinical trial reports up to the standard conducted by the first successful applicant in addition to all the required documents set out in Paragraph 1 Item 1, 2 and 5-7. If the first successful applicant of a new indication (including changes of indications and addition of indications) did not conduct local clinical trials; or the approval was issued more than 5 years ago, then any other applications of drugs with the same ingredients, dosage form and dose, either for licensing the new indication or for adding the new indication to an existing license, should provide all the required documents set out in Paragraph 1 Item 1, 2 and 5-7. If labels and package inserts are revised according to the indications announced by the central health competent authority, the license holder should submit the application form for post-approval changes and the original copy of drug license when applying for post-approval changes of indications.