China Finalizes Revised Drug Distribution Rules

China's State Food and Drug Administration (SFDA) has announced the release of the revised pharmaceutical Good Supply (Distribution) Practices (GSP) slated to take effect on 1 June 1 2013, with a three-year transition period for the implementation by companies of the mandated quality control system.

Drug makers who fail to meet the amended GSP standards by 2016 will not be allowed to continue operations, regulators said.

This is the first major revision of the GSPs in more than a decade, and according to SFDA the revisions draw on those of the "World Health Organization (WHO), and the regulatory policies of the United States, the European Union and other developed countries and regions." 

The revisions include the obligation to implement a quality control system with an electronic drug monitoring system, bar codes to ensure pharmaceutical traceability, use of standardized documentation and information technology, and ensuring that responsible persons are properly qualified. 

A draft version of the revised GSPs was made available for comment on 25 April 2012.

 

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