The hottest SFDA release 2010 edition of Chinese P

SFDA issues the implementation of the 2010 edition of Chinese Pharmacopoeia, which has been officially implemented since October 1. The 2010 edition of the Pharmacopoeia of the people's Republic of China (hereinafter referred to as the Chinese Pharmacopoeia) has been promulgated by the Ministry of health Announcement No. 5 in 2010 and will be implemented as of October 1, 2010. Recently, the State Food and Drug Administration issued an announcement on the implementation of more than 2000 pharmacopoeias of new projects in China throughout the year

the announcement points out that for all the varieties contained in the Chinese Pharmacopoeia, the standards for the same kind of drugs originally contained in the previous Pharmacopoeia, the drug standards issued by the Ministry of health, the new drug confirmation standards issued by the State Food and Drug Administration and the local standards issued by the State Food and drug administration will be abolished at the same time since the date of implementation. If the accuracy reaches 1%, it is enough for the national standards. If the drug registration standard does not meet the relevant requirements of the Chinese Pharmacopoeia, the drug manufacturer shall submit a supplementary application in accordance with the relevant provisions of the measures for the administration of drug registration. If the inspection items contained in the drug registration standard are more than those specified in the Chinese pharmacopoeia or the quality indicators are higher than the requirements of the Chinese Pharmacopoeia, the corresponding items and indicators of the original standard should be implemented on the basis of the implementation of the Chinese Pharmacopoeia and the stability of measurement. The quality standard of the preparation specifications that are not included in the category of the Chinese Pharmacopoeia shall be implemented in accordance with the relevant requirements of the same category of the Chinese Pharmacopoeia, and the specification items shall be implemented in accordance with the original approval documents, and the product certification certificate recognized by the state has been obtained. The notice emphasizes that drug manufacturers should change the instructions and labels of drugs according to the updated contents of the Chinese Pharmacopoeia and the relevant regulations and procedures of the State Food and drug administration. Drugs produced since October 1st, 2010 must use the changed instructions and labels. For drugs whose generic name has been revised, the original name can be used as a former name

local food and drug supervision and administration departments at all levels should cooperate in the publicity and implementation of the Chinese Pharmacopoeia, strengthen the supervision and guidance in the implementation of the Chinese Pharmacopoeia, and timely collect and feed back relevant problems and opinions