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About importing drugs test at the factory packaging issues

About importing drugs test at the factory packaging issues

Jiangsu Food and Drug Administration:

Bureau you "about Eisai (China) Pharmaceutical Co., Ltd. Test Item relating to the United States can ask the question" (Su An Fresh Drug 〔2009〕 2) receipt. After studying and is now proposing the following views:

1, "Register pharmaceutical management approach," states: "The import of drugs refers to drugs are sub-packaged in formulations eventually finish outside the production process, at the territory of packaging specifications changed by small packing specifications, or to have been completed within the outer packaging of drugs packaging, placement instructions, paste, etc. tags. "" packaged product inspection and testing of imports of the same pharmaceutical standards. "

Given the sub-packaged products imported drugs is based on the importation of medicines management, "Imported Drug Report" is a statutory inspection reports, pharmaceutical quality assurance should be the responsibilities of pharmaceutical companies outside the commitment has been completed within the packaging of the preparations for sub-packaging ago, sub - packaging enterprises with foreign pharmaceutical companies agreed to the factory test mode, and strictly to ensure drug quality, but without external inspection report issued by drugs.

Two, sub-packaging products should in principle be batch imported products with the corresponding "Imported Drug Report" test batch consistency. Hours after the packaging is necessary in batches, and by foreign pharmaceutical companies agreed to the preparation of sub-batch number, batch number and issued by the relevance of documents.

Three, import large packaging drugs at sub-packaging for longer periods of time before the storage and transportation, sub-packaging business to deal with sub-packaged drugs at the validity of the stability study to assess the process of imports and sub-packaging of pharmaceutical quality.

State Food and Drug Administration's Office
March 18, 2009