The Pharmacopoeia Commission of China Food and Drug Administration (“CFDA”) recently published the Compilation Plan of Chinese Pharmacopoeia 2020 (Draft for Comment) (“Draft”) to seek public comments until 1 December 2016. The Draft offers guidance for the compilation work of the 2020 edition of Chinese Pharmacopoeia. It also aims to increase the types of drugs covered by the Chinese Pharmacopoeia and weed out drugs that do not meet current standards. A Drug’s common clinical application, proven efficacy, safe usage, mature manufacturing process and controllable quality will be key considerations for inclusion on or removal from the list.
According to the Draft, Chinese Pharmacopoeia 2020 will have four sections, i.e. Traditional Chinese Medicines (“TCM”), Chemical Drugs, Biologics and General Notices/ Pharmaceutical Excipients. The main amendments are summarised as follows:
- Section I - TCM: 220 new types of drug to be added; 500 current types of drug to be revised; standards of safety and efficacy of TCM will be improved by strictly limiting the content of heavy metal and hazardous residues;
- Section II - Chemical Drugs: 420 new types of drug to be added; 600 current types of drug to be revised; the principle of Consistency Evaluation shall apply; the analysing method for new types of formulations (sustained and controlled release preparations) will be established; standards of the safety, efficacy and quality control will be stricter;
- Section III - Biologics: 30 new types of drug to be added, including prioritising vaccines covered by the National Immunisation Program,; 150 current types of drug to be revised; the classification of biologics to follow the international categorisation;
- Section IV - General Notices/ Pharmaceutical Excipients: 100 new types of excipients to be added; 150 current types of excipients to be revised.
Technical requirements defined in the Chinese Pharmacopoeia would apply for all the researchers, manufactures (importers), operators, users and supervisors. The current Chinese Pharmacopoeia 2015 came into force on 1 December 2015 and is still effective. As the Draft is still open for public comment, it still remains to be seen when and how the Chinese Pharmacopoeia 2020 will be issued.