2014.05.07.WED

Other Regulatory Matters

Measures for Administration of Oversea Pharmaceutical Manufacturing Enterprise Inspection (China)

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Author:GMP Platform

Measures for Administration of Oversea Pharmaceutical Manufacturing Enterprise Inspection (China)

(for Trial Implementation) (Exposure Draft)


Article 1 In order to regulate the inspection of the oversea pharmaceutical manufacturing enterprise, this measure is enacted according to 'Drug Administration Law of the People's Republic of China','Regulations for Implementation of the Drug Administration Law of the People's Republic of China', 'The State Council's Special provisions on strengthening the supervision and administration of food and product safety' and other regulations.

Article 2 Inspection of the oversea pharmaceutical manufacturer is organized and carried out by the China Food and Drug Administration(hereinafter referred to as 'CFDA')to inspect the oversea manufacturing site of imported drugs which are in the process of registration, approving or of those which  has been approved to be imported. It aims to strengthen the supervision and administration of the imported drug so as to assure quality and safety of imported drug.

Article 3 This measure applies to all the oversea pharmaceutical manufacturers which has been issued 'Registration Certificate of Imported Drugs' or 'Registration Certificate of Pharmaceutical Drugs' by CFDA, and those who are applying for 'Registration Certificate of Imported Drugs' or 'Registration Certificate of Pharmaceutical Drugs'.

『Please refer to PDF for the original text in Chinese』
 

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