Release of technical guidelines for naming generic names of Chinese patent medicines

[policies and regulations of chinapharma.com] on November 28, CFDA issued the technical guidelines for generic name naming of Chinese patent medicines The new Chinese medicine accepted after the issuance of the guiding principles shall be named according to the requirements of the technical guiding principles; if the name of the new Chinese medicine accepted is inconsistent with the technical guiding principles, the registration applicant may rename it through supplementary application The exceptions that can not be renamed are: for the drugs that have already been listed, those that violate the naming principle should be standardized CFDA requires that the names of Chinese patent medicines in the following three cases must be renamed: 1 Those that obviously exaggerate the efficacy and mislead doctors and patients; 2 Those whose names are incorrect, unscientific, vulgar and superstitious 3 The prescription is the same but the drug name is different, and the drug name is the same or similar but the prescription is different There are also exceptions that do not need to be renamed for the names of Chinese patent medicines that are inconsistent with the technical guidelines CFDA has made it clear that there are place names, person names and surnames for the names of medicines, and there are "Bao", "Jing" and "Ling" in the names of medicines, but the varieties have a certain use history, have formed brands, and are generally accepted by the public, so it is not allowed to be renamed In addition, all kinds of traditional Chinese medicine preparations derived from ancient classic prescriptions will not be renamed The State Pharmacopoeia Committee shall be responsible for the issuance of the list of Chinese patent medicines to be renamed It will organize experts to review and propose the list of Chinese patent medicines to be renamed, and solicit public opinions After the list is determined and published, all Chinese patent medicines listed in the list shall be renamed For the Chinese patent medicine to be renamed, after the approval of the name change, a 2-year transition period (calculated from the date when the new name is announced) will be given During the transition period, the old name will be included after the new name, so that patients and doctors can gradually adapt CFDA requires that, within 30 days from the date of approval of the name change, the manufacturer shall file the new instructions and labels with the local provincial food and drug administration For drugs manufactured from the date of filing, the original instructions and labels shall not be used For the drugs manufactured before the filing, if the validity period is within the 2-year transition period, the original instructions and labels can be used until the end of the validity period; if the validity period exceeds the 2-year transition period, the original instructions and labels can be used until the end of the transition period CFDA also defines the process of name change application Within 2 months after the publication of the list of Chinese patent medicines to be renamed, the relevant manufacturers shall submit the proposed generic name to the National Pharmacopoeia Committee in the form of an official letter, and submit relevant information: 1 Provide more three generic names in accordance with the technical guidelines for the naming of generic names of Chinese patent medicines, arrange them in the recommended order, and elaborate the naming basis 2 Issue the search results that are not the same as the approved registered drug names in the drug data query system of the government website of the State Food and drug administration 3 For varieties involving more than one enterprise, each enterprise may propose to change its name separately, or jointly issue an official letter (stamped with its official seal) after consensus, recommending one enterprise to propose to change its name The national pharmacopoeia committee will organize experts to review the general name of the proposal put forward by the enterprise, publicize the results of the review, and then study the feedback collected by the publicity, and determine the general name after the name change After that, the national pharmacopoeia committee will report the audit results to CFDA for release Original title: two years transition period for products to be renamed after the release of the naming principles of Chinese patent medicine