Regulations for Registration of Medicinal Products - Chapter - Laws & Regulations Database of The Republic of China (Taiwan)

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Chapter Law Content

Title：	Regulations for Registration of Medicinal Products CH
Category：	Ministry of Health and Welfare（衛生福利部）
Attachment：	Appendix1：Maximum Drug Package Size Dosage.pdf Appendix 1-1：Prescription Drug’s Package Insert Format.pdf Appendix 2：Documents for the Application forDrug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths.pdf Appendix 3：Technical Documents for the Application for Drug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths.pdf Appendix 4：Documents for the Application for Drug Review and Registration of Generics.pdf Appendix 5：Technical Documents for the Application for Drug Review and Registration of Generics in the Dosage Forms of Liposome or Transdermal Absorption.pdf Appendix 6：Documents for the Application for Drug Review and Registration of Bio-Pharmaceutical Products.pdf Appendix 7：Technical Documents for the Application of Drug Review and Registration of Bio-Pharmaceutical Products.pdf Appendix 8：Documents for the Application of Drug Review and Registration of API.pdf Appendix 9：Technical Documents for the Application of Drug Review and Registration of API.pdf Appendix 10：Documents Required for the Application for Drug Review and Registration of Radiopharmaceutical Drugs.pdf Appendix 11：Technical Documents Required for the Application for Drug Review and Registration of New Drugs, New Dosage Forms and New Dose of Radiopharmaceutical Drugs.pdf Appendix 12.PDF Appendix 12.doc Appendix 12-1：Matters that Should be Applied for Changes of Manufacturing Process and Batch Size of Drug Product.pdf Appendix 12-2：Documents for the Application of Registration Changes of Manufacturing Process and Batch Size of Drug Product.pdf Appendix 13.pdf

Chapter 2 Western Medicine

Section 5 License Extension

Article 72

Applications for license extension should be filed within six months prior to the expiration date. Applications filed after the deadline will not be processed and the applicants will have to re-apply for drug registration. Those re-applying for drug registration within three months from the expiration of a license are eligible for a simplified procedure as stated in Article 73.
If an application of license extension also involves other post-approval changes, then these applications should be made separately.
If the space on the license for specifying the expiration date is full, the manufacturer can apply for a new copy of license by submitting the original copy of the application form for drug registration.

Article 73

The following documents are required for application for license extension:
1. Original drug license;
2. Application form for drug license extension;
3. For drugs manufactured domestically, supporting documents of GMP compliance certificate and full formula contents shall be provided; for drugs manufactured by toll-manufacturers, the contract of toll-manufacturing shall also be attached;
4. For imported drugs, the original CPP from the country of origin, the original letter of authorization issued by the original manufacturer and a photocopy of the GMP compliance certificate for the foreign manufacturing site of imported drugs shall be included. If the holder the GMP compliance certificate is not the applicant, then this document can be substituted by a letter of authorization issued by the original manufacturer or the local drug company holding the certificate, therein specifying the approval number of the original certificate. For the imported drug substances, the CPP can be exempted.
5. The supporting documents of the GMP compliance certificate of the active pharmaceutical ingredients.
6. The post-approval letter of the specifications and testing methods according to the latest edition of pharmacopoeia or the manufacturer’s specifications. If the specifications are not changed, the assessment statement should be provided.