Chinanews.com, January 4th. According to news from the State Food and Drug Administration on the 4th, the State Food and Drug Administration issued a notice on printing and distributing "Several Measures to Further Strengthen the Scientific Supervision of Traditional Chinese Medicine and Promote the Inheritance and Innovation of Traditional Chinese Medicine" (hereinafter referred to as "measures").
The "Measures" strengthen the quality management of traditional Chinese medicinal materials, strengthen the supervision of traditional Chinese medicine decoction pieces and traditional Chinese medicine formula granules, optimize the management of traditional Chinese medicine preparations in medical institutions, improve the review and approval mechanism of traditional Chinese medicine, attach importance to the management of traditional Chinese medicine after listing, improve the standard management level of traditional Chinese medicine, and increase the safety supervision of traditional Chinese medicine 35 measures have been made in 9 aspects to promote the global cooperation of traditional Chinese medicine supervision.
In terms of safety supervision of traditional Chinese medicine, the "Measures" proposes to innovate the quality supervision model of traditional Chinese medicine.
Gradually build a "grid" supervision model, improve the construction of the traditional Chinese medicine production supervision system, research, formulate and supervise the implementation of the "Quality Management Standards for Traditional Chinese Medicine Production".
Gradually establish and improve the regional risk research and judgment mechanism of traditional Chinese medicine production, continue to strengthen the supervision and inspection of traditional Chinese medicine decoction pieces, traditional Chinese medicine formula granules and Chinese patent medicines for key enterprises, key varieties, and key links, and carry out extended inspections of Chinese medicinal materials in an orderly manner.
Further standardize the circulation and operation order of traditional Chinese medicine decoction pieces, traditional Chinese medicine formula granules, and Chinese patent medicines, and strengthen the quality supervision of the use link.
Strengthen the sampling inspection and monitoring of the quality of traditional Chinese medicine.
Continue to promote and improve the quality sampling inspection of Chinese herbal decoction pieces, traditional Chinese medicine formula granules, and Chinese patent medicines, scientifically carry out exploratory research in combination with regulatory needs and the actual development of the industry, conduct comprehensive analysis and judgment on sampling monitoring data, and take corresponding risk prevention and control or quality improvement measures according to risks , Optimize the working mechanism for the release of quality announcements of traditional Chinese medicines, release the results of random inspections and monitoring according to law, and objectively and accurately convey information on the quality and safety of traditional Chinese medicines to the public.
Severely crack down on violations of laws and regulations.
Strictly investigate and deal with drug marketing authorization holders, production and/or distribution companies suspected of fraudulent registration and filing, adulteration, falsification of records, illegal sales and other violations in accordance with the law.
Severely crack down on illegal and criminal activities such as the manufacture and sale of counterfeit traditional Chinese medicines in "dens", make full use of clues such as network monitoring, complaints and reports, and cooperate with public security, judicial and other departments to resolutely find out the source, pursue it to the end, and pursue the criminal responsibility of criminals in accordance with the law. Bottom line of safety.
(China New Finance and Economics)