Laws Information

法規資訊
Title: Regulations for Medicament Contract Manufacture and Analysis
Am Date: 2013-08-02
Legislative History: Articles 8 and 12 amended and issued per 2 August 2013 Ministry of Health and Welfare Order No. Bu-Shou-Shi-1021101814

Transaction

Amendment

Article 8
A contract manufacturer shall be a medicinal product factory in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.

Article 12
An entity that conforms with any of the following descriptions may accept a contract for analysis of drug (medicinal) products:
1. A medicinal product factory that is in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.
2. A domestic or foreign academic research institute that meets the requirements of good laboratory practices for non-clinical laboratory studies.
3. An analysis institution or laboratory that meets the certification requirements under Article 104-4 of the Act.
4. Other entity approved on an ad-hoc basis by the competent central health authority.