The State Food and Drug Administration issued a notice to officially launch the new drug GMP certificate

Recently, the State Food and Drug Administration issued a notice regarding the opening of a new version of the GMP certificate for pharmaceuticals. The notice described the difference between the appearance of the new version of the GMP certificate and the old version. It also required the relevant departments to seriously carry out the serial number of the new certificate. Registration, issuance, etc., The new version of the GMP certificate for pharmaceuticals will be available on the date of the announcement.

The specific details of the notice are as follows:

Notice of the Office of the State Food and Drug Administration on the Enabling of a New Version of the Drug GMP Certificate (Food and Drug Administration Office [2011] No. 137)

Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:

In order to do a good job in the implementation of the "Guidelines for the Quality Control of Pharmaceutical Production (Revised in 2010)" (Drug GMP), the State Bureau revised the "Drug GMP Certificate" style and it was officially launched on the date of this announcement. The relevant matters are hereby notified as follows:

I. The provincial food and drug supervision and management departments should follow the "Circular on Implementing the Regulations for the Quality Control of Pharmaceutical Production (Revised in 2010)" (Guo Shu Yao (2011) No. 101) and pass new amendments to the drug. GMP inspection and certification of the dosage form (product), numbering and issuing a new version of the "Drug GMP Certificate." For the dosage forms (products) that have been accepted before March 1, 2011 and inspected and certified in accordance with the "Standards for the Quality Control of Pharmaceutical Manufacturing (1998 Revision)", the original version of the "Drug GMP Certificate" was issued after passing the certification.

2. The new version of the "Drug GMP Certificate" is light blue in color and the content and format are the same as those in the original "GMP GMP Certificate." Specific style attached later.

Third, the provincial food and drug supervision and administration departments should strengthen the management of the "Drug GMP Certificate," and do a good job of numbering, registration, and distribution, so that they can be orderly, indiscriminate, and have a smooth transition.

All provincial food and drug supervision and administration departments shall, in accordance with the actual work of drug certification and inspection within the administrative region, contact the Administrative Service Acceptance Service Center of the State Bureau and obtain a new version of the "Drug GMP Certificate."

National Bureau of Drug Safety Supervision Department Contact: Weng Xinyu, Guo Qingwu Tel: 010-88330812, 88330852

Fax: 010-88330854

National Bureau Administrative Service Center Contact: Liu Si, Zhang Yanli Tel: 010-88372751, 88370563

Fax: 010-88363840