Pharmacopoeia of the People's Republic of China (2010 Edition): An Overview
The Pharmacopoeia of the People's Republic of China (PPRC) is the official and authoritative compendium of standards for the quality and safety of drugs in China. It covers various types of drugs, such as traditional Chinese medicines, chemical drugs, biological products, and pharmaceutical excipients. The PPRC is compiled and revised by the Chinese Pharmacopoeia Commission (ChPC) under the supervision of the National Medical Products Administration (NMPA) and the National Health Commission (NHC).
The 2010 edition of the PPRC was published in June 2010 and came into effect on July 1, 2010. It consists of three volumes: Volume I contains 2,645 monographs of traditional Chinese medicines and their preparations; Volume II contains 2,536 monographs of chemical drugs, antibiotics, biochemical drugs, and radioactive drugs; and Volume III contains 126 monographs of biological products. The 2010 edition also includes 318 general chapters that provide general requirements, testing methods, standard substances, reagents, and guidelines for drug quality control.
Pharmacopoeia of the People s Republic of China (2010 ....pdf
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The 2010 edition of the PPRC reflects the latest achievements and developments in drug research and regulation in China. It incorporates new drugs that have been approved by the NMPA, updates existing monographs according to the latest scientific evidence and international standards, and strengthens the quality control of traditional Chinese medicines and biological products. The 2010 edition also promotes the application of modern analytical techniques, such as chromatography, spectroscopy, and molecular biology, to improve the accuracy and reliability of drug testing.
The PPRC is an important reference for drug manufacturers, distributors, researchers, regulators, and users in China and abroad. It provides authoritative and comprehensive information on the quality and safety of drugs in China and contributes to the development and harmonization of drug standards in the world.
The PPRC is revised every five years to keep pace with the rapid development and innovation of drugs in China and the world. The latest edition of the PPRC is the 2020 edition, which was approved by the NMPA and the NHC in July 2020 and came into effect on December 30, 2020. The 2020 edition consists of four volumes: Volume I covers traditional Chinese medicines and their preparations; Volume II covers chemical drugs, antibiotics, biochemical drugs, and radioactive drugs; Volume III covers biological products; and Volume IV covers general chapters and pharmaceutical excipients. The 2020 edition contains a total of 5,911 monographs, including 1,303 new monographs, 1,034 revisions, and 43 deletions.
The 2020 edition of the PPRC has made significant improvements and innovations compared to the previous editions. It has expanded the scope and coverage of drug standards, enhanced the quality control of traditional Chinese medicines and biological products, adopted advanced and mature analytical techniques, strengthened the testing methods for exogenous pollutants in drugs, and harmonized the technical requirements with international standards. The 2020 edition also provides guidance and support for the development of new drugs, such as innovative drugs, biosimilars, gene therapies, and cell therapies.
The PPRC is not only a national standard for drug quality and safety in China, but also a valuable resource for drug research and development in the world. It reflects the achievements and progress of drug science and technology in China and contributes to the global health and well-being of mankind. 29c81ba772