The ninth and tenth batches of the new edition of the General Principles of the fourth part of the Pharmacopoeia
On April 3, the State Pharmacopoeia Commission issued the ninth and tenth announcements of the fourth general principles of the 2020 edition of the Chinese Pharmacopoeia.
In accordance with the schedule of the preparation of the 2020 edition of the Chinese Pharmacopoeia, the first draft of the revision of the four general principles has been consulted in batches on the National Pharmacopoeia Commission's network since February 2018 for public comments.
Based on the feedback and suggestions of the first draft, the State Pharmacopoeia Commission organized various relevant professional committees to discuss and form 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 the Pharmacopoeia, the network of the State Pharmacopoeia Commission now solicits opinions publicly for a period of one month.
Among them, the ninth batch includes microbial counting method, bacteriostasis potency test method, bacterial endotoxin test method, protamine sulfate potency test method, and quality management guidelines of Pharmaceutical Microbiology laboratory. All the above contents are for the second time to solicit opinions.
The tenth batch of requests included aseptic testing, isolation system validation guidelines for aseptic testing, bio-indicator guidelines for sterilization, and bio-indicator tolerance testing guidelines, all of which were for the third time for comments.
According to the time of the new edition of the Pharmacopoeia, on August 23, 2018, the State Pharmacopoeia Commission began to publish the announcement of the contents of the four general principles of the 2020 edition of the Chinese Pharmacopoeia, and then accelerated the content of the new edition, especially since 2019, the announcement time has been shortening.
The Chinese Pharmacopoeia was first published on June 5, 2015 and was created by the National Pharmacopoeia Commission. Pharmacopoeia includes general examples, text and appendices, which are the legal basis for drug development, production, operation, use and supervision. 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 publications: one contains medicinal materials and slices, vegetable oils and extracts, prescription preparations and single preparations, the other contains chemical drugs, antibiotics, biochemical drugs and radiopharmaceuticals, the third contains biological products, and the fourth contains general principles, including general principles of preparation, testing methods and guiding principles. Standard substances, general rules of test solution and drug test, medicinal excipients, etc.
The 2010 edition of the Pharmacopoeia further expanded the collection and revision of drug varieties. The data show that the total number of varieties in the Pharmacopoeia of 2015 edition reaches 5608, which is 1082 more than that in the Pharmacopoeia of 2010 edition. The 2015 edition of the Pharmacopoeia integrates the appendices of one, two and three parts and adds them to the fourth part of the Pharmacopoeia, which makes the classification of the Pharmacopoeia clearer and clearer.
It can be said that the Pharmacopoeia is the technical stipulation made by the state to guarantee the quality of medicines and the quality index of medicines, which makes the development, production, operation, use and management of medicines in enterprises more standardized and more reliable. While guaranteeing the safety of medicines used by the public, it also promotes the improvement of the quality of medicines in China and speeds up the technological progress and products of enterprises. Upgrading and upgrading, promoting the adjustment of China's pharmaceutical industry structure, and will further expand and enhance the positive impact of China's Pharmacopoeia in the international arena.
According to the network of the State Pharmaceutical Administration, the National Conference on drug registration management and post-marketing Supervision held from January 17 to 18 deployed the key work of drug registration management in 2019, which mentioned that the preparation of the Chinese Pharmacopoeia (2020 edition) should be further promoted.
It is reported that the 2020 edition of the Pharmacopoeia has put forward the requirement of moderate growth of variety collection. First, the adjustment of catalogue should be considered. Second, the working tone should be changed from focusing on the quantity of drug collection to focusing on the improvement of the internal quality of drugs.
At present, the new edition of the Pharmacopoeia is steadily advancing, and 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 edition of the Pharmacopoeia will further improve the standard system and strengthen the concept of the whole process management of drug quality. In addition, the new edition of the Pharmacopoeia will establish a mechanism for eliminating the national drug standards by subtracting some drug varieties that have cancelled the drug approval number, long-term non-production, uncontrollable quality, unreasonable dosage forms and low stability.