China implements batch release system for biological products

2008-07-18 02:08:03 GMT       2008-07-18 10:08:03 (Beijing Time)       Xinhua English

BEIJING, July 18 (Xinhua) -- China conducts compulsory inspection and approval for each batch of biological products before the products leave the factories for marketing, or are imported, says a white paper published by the Information Office of the State Council on Friday.

Items which fail the inspection or approval shall not be allowed to be marketed or imported, says the paper.

Since 2001, China has gradually implemented the batch release system for such biological products as vaccines, blood products and in-vitro diagnostic reagents used for blood screening tests. Since January 1, 2006, all preventative vaccine products have been subject to approval by this batch release system; starting from January 1, 2008, all blood products must be subject to the batch release system, it says.

This batch release system for biological products plays a vital role in controlling infectious diseases like AIDS, as well as in safeguarding the public health, says the paper.

The paper says that all enterprises that apply for drug manufacturing or distribution shall be subject to examination in terms of staff qualifications, factory environment, equipment and facilities, business site, storage conditions and organization of quality management.

Production or sales licenses are granted only when enterprises meet the requirements, says the paper, since the adoption of the drug licensing system, Chinese drug regulatory departments have identified qualified pharmaceutical enterprises through regular inspections and re-issuing of certificates after examination.

In China, packaging containers and materials that are in direct contact with drugs must meet the standards for drug use, says the paper, drug labels shall be printed on or attached to drug packaging and insert sheet shall be included.

The paper says that drug regulatory departments shall archive review or record for drug packaging, labeling and insert sheet in accordance with the Provisions on the Administration of Drug Insert Sheet and Labeling.

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