Controversy and discussion caused by implementation announcement of Chinese Pharmacopoeia 2015

Source: the promulgation and implementation of CPHI pharmaceutical online 2015-7-21 Chinese Pharmacopoeia 2015 is destined to be a major event in the Chinese pharmaceutical industry in 2015, and also a hot spot for practitioners in all aspects of the pharmaceutical industry On July 15, 2015, CFDA issued the notice of the State Food and Drug Administration on the implementation of the Pharmacopoeia of the people's Republic of China (version 2015), which put forward specific requirements for the implementation of the Pharmacopoeia of the people's Republic of China (version 2015) This is an important document issued for the implementation of Pharmacopoeia According to my own analysis, the contents of this announcement are analyzed one by one 1、 The Chinese pharmacopoeia is a legal technical standard for drug development, production (import), operation, use, supervision and management [analysis] the first article introduces the scope of use of Pharmacopoeia Whether it is drug research and development, drug production, drug import, drug sales and drug use, as well as law enforcement and supervision of drug regulatory agencies at all levels, it needs to follow the requirements of Pharmacopoeia There is no principle error in this article, but in the use of drugs, the information provided by pharmacopoeia is very little, and more should follow the information sources such as drug instructions and labels 2、 The 2015 edition of Chinese Pharmacopoeia includes general rules, text and general rules From the date of implementation, all drug standards (including drug registration standards) for production and marketing shall comply with the relevant General requirements of this edition of Pharmacopoeia [analysis] the second article introduces the main components of the Pharmacopoeia and the general requirements of the Pharmacopoeia, which are the basic requirements for all drugs to be listed The beauty of this article is that it does not introduce the relationship between the supplement and pharmacopoeia So far, when the pharmacopoeia is published every five years, the announcement is issued, but when the supplement is issued, the announcement is not issued 3、 As of the date of implementation, the national drug standards for the same variety originally collected and published in the Pharmacopoeia of the Chinese Pharmacopoeia (2015 Edition) and the State Administration (Ministry) shall be repealed at the same time.