Taiwan Publishes a Separate Standards of Review Fees for the Registration of Western Medicines

Standards or Review Fees for the Registration of Western Medicines
Considering the increase in complexity and novelty of the western medicine drug review, a relatively high technical and professional review is required. A relatively large amount of manpower for review and related system and facilities are invested in cost analysis estimates (including direct costs: manpower, materials, equipment, utilities, etc., indirect costs: file processing, warehousing, storage, etc.), reflecting the actual operating costs. These standards replace the relevant charging items related to Western medicines in the current “Standards of Review Fees for Western Medicines and Medical Devices”.

The main points are as follows:
1. The basis of this standard. (Article 1);

2. Formulate the 18 items that will be charged and the amount of the fees. (Articles 2 to 9), including for:
-new drug applications, generic drug applications, biological drugs application;
-clinical trial applications, BA & BE studies, good clinical practice onsite inspections
-API applications
-GMP and GDP inspections
-post-approval change or extension or reissue due to damage or loss of drug licenses
-related certificates and reference letters
-Letter of inquiry

3. On-site inspections of manufacturing plants and GCP on-site inspections shall be handled in accordance with the key points for reporting and support of travel expenses abroad. (Article 10); AND

4. In order to facilitate drug dealers to draw up cost planning at the time of application, the implementation date of this standard is from 1st January 2021. (Article 11);

More information could be obtained here:-

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