Comparison of General Technical Requirements for Similar Content Published by Pharmacopoeia Agencies and Drug Regulatory Agencies in China,United States,Europe,and Japan
OBJECTIVE To provide reference and guidance for improving the development mechanism and content of guidelines(general technical requirements)for similar content published by Chinese pharmacopoeia commission and drug regulatory agency.METHODS By reviewing the similar guidelines(general technical requirements)published by pharmacopoeia commissions and drug regu-latory agencies in China,the United States,Europe,and Japan,a comparison and analysis were conducted on their similarities,differences,and mutual references in terms of their development purposes,scope of application,and specific content.RESULTS In terms of prepara-tions,biological products,stability,impurities,dissolution,rmicrobiological testing methods,and validation of analytical methods,pharmaco-poeia commissions and drug regulatory agencies in China,the United States,Europe,and Japan have similar guidelines(general technical requirements),and there are differences in the purposes and focuses.Except for China,other countries or regions have less repetitive content and no conflicting content in the guidelines(general technical requirements)for similar content published by pharmacopoeia commissions and drug regulatory agencies.The two complement each other and jointly support the drug standard system.CONCLUSION It is recommended that China's drug regulatory agency take the lead in determining the subjects,further optimizing and improving the harmonization mechanism,and harmonizing and unifying the guidelines(general technical requirements)developed by pharmacopoeia commission and drug regulatory agency based on the functions of each agency,to ensure that the two are clearly positioned in terms of development purposes,scopeof application,and content.Strengthen the interoperability of similar content guidelines published by pharmacopoeia agency and drug regulatory agency and keep pace with international standards.
万方数据
维普
