FAQ
Drugs

What requirements for contract analysis entity of drug products shall be met?

刊登日期:2019-11-22  |  點閱次數 : 1529 次 

According to Article 12 of the Regulations for Medicament Contract Manufacture and Analysis, an entity that conforms to any of the following descriptions may accept a contract for the analysis of drug products:

  1. 1. A medicinal product factory that is in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.
  2. 2. A domestic or foreign academic research institute that meets the requirements of good laboratory practices for non-clinical laboratory studies.
  3. 3. An analysis institution or laboratory that meets the certification requirements under Article 104-4 of the Pharmaceutical Affairs Act.
  4. 4. Other entity certified on an ad-hoc basis by the competent central health authority.

(中文版)


上一筆 What documents should be submitted for the registration of a drug substance (API)
下一筆 Is there any clear description of domestic regulation regarding that the scale of