Drugs
【Update Date:2019-01-22】unit:藥品組
Generic Drug-related:
1. Generic Drug: Preparations that have the same composition and are of the same formulation, the same dosage, and the same efficacy as those of drugs already domestically approved.
2. Letter of Authorization: The supporting document for authorized registration, as issued by the foreign manufacturer or its main office, or by the holder of a foreign permit, for a drug being imported.
3. FSC from the country of origin: The original copy of the supporting document for the authorized manufacturing and free sale in the country of origin, issued by the highest local competent health authority, and in compliance with the requirements in Article 6 of the Regulations.
4. Certification adopted: Unless specified otherwise in the Regulations, this must be issued by the competent health regulatory authority of the country where it is adopted, and verified by the ROC Representative Office in the country.
5. Prescription basis: Unless otherwise specified, this shall be based upon the pharmacopoeia or official books published in the Top 10 medically advanced countries, and shall be limited to a five-year period since their initial publication (the requirements in Article 8 of the Regulations shall be fulfilled).
6. Batch manufacturing record: Manufacturing records from the same batch as the samples submitted for testing.
7. Excipient: Additives in the preparation other than the active ingredient.
8. Acceleration test: A test performed in order to reinforce the chemical degradation or changes to physical properties of pharmaceutical products or drugs by strengthening the storage conditions, so that information may be obtained within a short period of time to help evaluate stability of the drug under normal storage conditions.
9. Manufacturing and Control StandardManufacturing Process Control Standards: Refers to the Manufacturing and Control Standard in compliance with Part 2 of Good Manufacturing Practice Regulations (Good Manufacturing Practices for Pharmaceuticals), including data of the actual amount of material used in batch records.Denotes the Manufacturing Process Control Standards specified in Part II of the Good Manufacturing Practice (the “GMP”) and includes the burden yield indicated in the batch processing record.