Industry News
An announcement on further improving the quality of the medicinal material in supervision work
The provinces, autonomous regions, municipalities directly under Food and Drug Administration (FDA Bureau), Xinjiang Production and Construction Corps Food and Drug Administration:
Recently, the news media reported that a phenomenon appeared in Min County, Longxi of Gansu Province that farmers and merchants fumigated Angelica herbal with sulfur, causing society a bigger echo. Chinese herbal medicine cultivation, planting and processing is related to the preparation of traditional Chinese medicine and Chinese Herbal Pieces quality safety, and this should cause various-level food and drug administrative departments to attach great importance to it. In order to ensure the quality and safety of medicines, the further strengthening quality supervision work is notified as follows:
1.Further improve the understanding of the importance of supervision on the quality of the medicinal material. Each province (district, city) food and drug administrative authorities should infer other things from one fact, check erroneous ideas at the outset, widen superintendency way of thinking, further strengthen the Chinese herbal medicine circulating supervision, strengthen the supervision and check on Chinese herbal medicines and Chinese herbal medicine business enterprises and professional traditional Chinese medicine market about sulfur fumigating medicine, strengthen market sampling inspection and further standardize the sales act of the Chinese herbal medicines and Chinese Herbal Pieces through Min County of Gansu sulfur smoked herbs event.
2.Strengthen the preparation of traditional Chinese medicine and herbal pieces of production supervision and inspection. Each province (district, city) food and drug administrative departments shall be in accordance with SFDA on ¡°Further Strengthening the supervision and inspection of Chinese medicine production¡±(State FDA safety [2010]No. 457)and SFDA together with the Ministry of Health, State Administration of traditional Chinese medicine jointly issued "on strengthening supervision and management of traditional Chinese medicine decoction pieces."
(State FDA safety [2011]No. 25), strengthen the quality inspection supervision to the preparation of traditional Chinese medicine and Chinese herbal medicine production enterprises purchasing Chinese herbal medicines and Chinese Herbal Pieces and deeply strengthen the on-site supervision and inspection of pharmaceutical production of the preparation of traditional Chinese medicine and Chinese medicine pieces of production enterprises.
3.Strengthen quality inspection of medicines and herbal pieces. SFDA is making limit standard of sulfur dioxide residues of Chinese herbal medicines and Chinese herbal pieces, each province (district, city) food and drug administrative authorities should set working time, requiring the production enterprises of traditional Chinese medicine and Chinese herbal medicine inside requirement area under administration to make the sulfur dioxide residue limit indicator as the enterprise internal control standards for testing materials. Where the enterprise fails to require the development of sulfur dioxide residues detection standard or not in accordance with the internal control standards on the purchase of medicines or Chinese herbal medicine inspection, medicine or herbal pieces shall not be used for production or feeding the production.
4.Strengthen coordination and cooperation with related departments. Each province (district, city) food and drug administrative departments should actively enhance communication and information exchange with agricultural, business, health and other departments, timely notifies sulphur fumigation of Chinese herbal medicine cultivation, planting and in the process of processing and other problems that affect the quality of medicinal material, actively cooperates with the relevant departments to take measures , catch condominium together, comprehensively govern, earnestly perform supervisory duties and ensure the quality and safety of traditional Chinese medicine and Chinese herbal medicine.
Each province (district, city) food and drug administrative authorities should timely report to the provincial people's government and the SFDA about the problems found in the work of quality supervision on the Chinese medicinal materials.
Contact : Guo Qingwu Weng Xinyu
Tele : 010-88330852, 88330812
Fax: 010-88330854
Office of SFDA
May 3, 2011