For the purpose of further strengthening the supervision of pharmaceutical precursor chemicals, regulating the production and supply order, and preventing them from flowing into illegal channels, the Provisions for Pharmaceutical Precursor Chemicals, drafted by the State Food and Drug Administration, and issued by the Ministry of Health on March 18, 2010, will come into force as of May 1, 2010. Provisions for Pharmaceutical Precursor Chemicals comprises 8 chapters and 50 articles, specifying the limits, conditions, procedures, data requirements, and approval time limit for the production, distribution, and purchase licensing of pharmaceutical precursor chemicals; the channels for the purchase and distribution of raw materials and prescribed preparations of pharmaceutical precursor chemicals, and small package ephedrine. The Provisions also regulate the system and condition requirement for the safety management of manufacturers, distributers, and the use of pharmaceutical precursor chemicals, and the supervision of the food and drug regulatory departments. |