Announcement of the ninth and tenth batch of the revised contents of the general principles of the fourth part of the new pharmacopoeia

[China Pharmaceutical network industry trends] on April 3, the State Pharmacopoeia Commission successively released the ninth and tenth batch of public announcement of the general principles of the fourth part of China Pharmacopoeia 2020 According to the preparation schedule of Chinese Pharmacopoeia (version 2020), the draft for comments on the revision of the general principles of the four ministries has been open to all sectors of the society in batches since February 2018 According to the feedback and suggestions of the draft, the State Pharmacopoeia Commission organized relevant professional committees to discuss, and sorted out the second draft (the ninth batch) and the third draft (the tenth batch) In order to further improve the contents of the general principles of Pharmacopoeia, the State Pharmacopoeia Commission now solicits public opinions for one month Among them, the contents of the ninth batch of solicitation include microbial count method, bacteriostatic efficacy test method, bacterial endotoxin test method, protamine sulfate titer test method, and guiding principles for quality management of Pharmaceutical Microbiology Laboratory, all of which are the second solicitation The contents of the 10th batch of solicitation include sterility inspection method, isolation system verification guidance principle for sterility inspection, biological indicator guidance principle for sterilization, and biological indicator tolerance inspection guidance principle, all of which are the third solicitation According to the time when the new edition of Pharmacopoeia was revised, on August 23, 2018, the State Pharmacopoeia Commission began to release the announcement on the contents of the four general principles of the Chinese pharmacopoeia in 2020, and then accelerated the content of the revised contents, especially since 2019, the publicity time has been shrinking The Chinese Pharmacopoeia was first published on June 5, 2015, and was created by the National Pharmacopoeia Committee Pharmacopoeia, including all cases, text and appendix, is the legal basis for drug development, production, operation, use, supervision and management All national drug standards shall conform to the relevant requirements of the Chinese Pharmacopoeia and the appendix
In terms of content, it is divided into four parts: one is to collect medicinal materials and decoction pieces, vegetable oil and extract, formula preparation and single flavor preparation; two is to collect chemical drugs, antibiotics, biochemical drugs and radioactive drugs; three is to collect biological products; four is to collect general principles, including general principles of preparations, inspection methods, guiding principles, general principles of standard substances and test solutions , pharmaceutical accessories, etc The 2010 edition of Pharmacopoeia further expanded the collection and revision of drug varieties According to the data, the total number of varieties collected in Pharmacopoeia 2015 reached 5608, 1082 more than that in Pharmacopoeia 2010 In the 2015 edition of Pharmacopoeia, the appendixes of the first, second and third parts were integrated, and the fourth part of Pharmacopoeia was added to make the classification of Pharmacopoeia more clear
It can be said that pharmacopoeia is a technical regulation made by the state to ensure the quality of drugs and the quality index of drugs, which makes the drug development, production, operation, use and management of enterprises more standardized and based It not only ensures the safety of public drug use, but also promotes the improvement of the quality of drugs in China, speeds up the technological progress of enterprises and the upgrading of products, and promotes the structure of the pharmaceutical industry in China The adjustment will further expand and enhance the positive influence of Chinese pharmacopoeia in the world According to the website of the State Food and drug administration, the national drug registration management and post marketing supervision meeting held from January 17 to 18 deployed the key work of drug registration management in 2019, which mentioned that the preparation of China Pharmacopoeia (2020 Edition) should be further promoted It is reported that the 2020 edition of Pharmacopoeia puts forward the requirements of moderate growth in the collection of varieties First, the adjustment of the catalogue should be considered Second, the work tone should be changed from focusing on the collection quantity of drugs to focusing on the improvement of the internal quality of drugs At present, the addition and revision of the new pharmacopoeia is steadily advancing, and it is expected to be published in 2020, with the number of drug varieties expected to reach about 6400 Among them, there are about 800 new varieties of traditional Chinese medicine, chemical medicine and biological products At the same time, the new pharmacopoeia will further improve the standard system and strengthen the concept of the whole process management of drug quality In addition, the new pharmacopoeia will establish the elimination mechanism of national drug standards, and "subtraction" will be made for some drug varieties that have already cancelled the approval number of drugs, have not been produced for a long time, have uncontrollable quality, unreasonable dosage forms and have low stability.