State Food and Drug Administration requires to implement <pharmaceutical production quality management standard (revised 2010)
For the good implementation of < pharmaceutical production quality management standard (revised 2010) (Ministry of Public Health, decree No,79 ) (hereinafter refers to management code), under the requirements of <Drug Administration Law> and decree No,79 from Ministry of Public Health, at present, State Food and Drug Administration issued the notification of implementation steps and relevant requirements.
Notification emphasizes that provincial food and drug supervision and management departments must attach great importance to the implementation work of <Management regulation>, fully understand the importance and complexity of the implementation of <Management regulation>, and fully understand the implementation importance of ensuring medicine quality and safety, promoting economic structural adjustment and industrial upgrading in medicine, further enhancing the competition capability of international pharmaceutical industry in China. It Is necessary to list <Management regulation> into importance of ‘Twelve-Five’ of medicine supervision and management work from food and medicine management departments at all levels, strengthen organizational leadership, and carry out implementation responsibilities, try to ensure all work to be properly arranged compound with actual situation development, make specific implementation programmers.
It points out that from March 1st, 2011, as for new pharmaceutical production enterprises, new established workshops of pharmaceutical production enterprises (reform, expanse) should comply with <Management regulation>. All existing aseptic medicine production of blood products, vaccines, injection should meet the requirements specification for the <Management regulation> before December 31th, 2013. Other medicine production should reach the <Management regulation> before December 31th, 2015. Those enterprises that can not meet the requirements should not continue to produce medicine after the above mentioned deadline.
Notification requires that provincial food and drug supervision and management departments should complete propaganda and trainings to <management regulation> in areas, strengthen medicine inspection authentication systems and capacity-building in areas, and carry out evaluation of inspection and authentication capability to its inspection and authentication organizations.
State Food and Drug administration and provincial food and drug supervision and management department start to accept authentication application of <management regulation> from pharmaceutical production enterprises since March 1st, 2011. Those enterprises which can meet the requirements of inspection and authentication will be issued with new number of <medicines GMP certificate>. Accepted authentication application before March 1st, 2011 will be processed according to original procedure and issue < medicines GMP certificate>, its validity up to the implementation period of this notification.
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