Food and Drug Administration will strictly to promote the implementation of new GMP
According to the meeting of national conference on food and drug supervision and management (December 20th, 2012), there are 154 medicine manufacturers have got the approval of revised pharmaceutical GMP certification examination. Director of national State Food and Drug Administration (hereinafter National Council) Shao Mingli stressed at the meeting that, it is necessary to do good job for the new drug GMP implementation, adhere to the principle of no relaxing criteria and no lowering standard.
According to the reports, there are 154 enterprises have passed authentication, among which 88 were examined and organized by the National Council for mainly injection and biological products. There are 66 were examined and organized by provincial Bureau for mainly in traditional Chinese medicine, API, tablets, capsules, etc. At present, the authentication is primarily for large and medium sized enterprises.
New amendments pharmaceutical GMP is a big measurement for protecting advanced productive forces, eliminating backward productive forces, promoting industrial structure readjustment, enhancing international competitive of China's pharmaceutical industry. <national medicine safety planning (2011-2015) > which was passed in the State Council meeting recently made it clear that ‘Twelve-Five’ medicine overall objective is: pharmaceutical production will be 100% in line with the new revision of <pharmaceutical production quality management standard> by 2015, medicine safety will sharply increasing, as well as the satisfaction of medication safety for the public.
It is understood that there are many problems in the implementation of new drug GMP: some enterprises are still waiting, over practice of reconstruction process, inadequate investment in software and staff, some supervision organizations lack of regulatory capacity. In order to promote the implementation and guarantee scheduled implementation in right place, promoting and implementing newly revised drug GMP has become one of the main points in 2012 food and drug supervision and management work. National Council will issue <opinion of implementation for strengthening pharmaceutical production quality management standard (revised 2010)> in the near future, specifically guide enterprises to implement revised drug GMP. National Council will strengthen guidance and management of provincial-level authentication l, and carry out inspection and check of provincial council authentication work.
Shao Mingli requires doing good job to the implementation of newly revised drug GMP in 2012. food and drug regulatory authorities at all levels should carry out overall arrangement step by step in accordance with drug GMP, adhere to the criteria of no relaxing criteria and no lowering standard, strengthen the supervision and guidance of production enterprises, and strict do on-site inspections to ensure harmonization as well as quality and efficiency for the certification.
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