Notice on the Relevant Matters Concerning the Implementation of the Chinese Pharmacopoeia

Municipal Food and Drug Administration:

The Pharmacopoeia of the People's Republic of China 2010 edition (hereinafter referred to as the "Chinese Pharmacopoeia") has been promulgated by the Ministry of Health No. 5 Announcement No. 5, with effect from October 1, 2010. For the implementation of the "Chinese Pharmacopoeia", according to the State Food and Drug Administration, "on the implementation of <Chinese Pharmacopoeia 2010 edition of the relevant matters of the notice" (No. 43, 2010) requirements, the relevant matters are hereby, please contact the area Within the relevant units in accordance with the implementation.

First, the pharmaceutical production enterprises should carefully check all registered varieties (including the name of the drug has changed the species), where the original was included in the calendar Pharmacopoeia, the Ministry of Health promulgated drug standards, the State Food and Drug Administration issued a new drug standards and local standards Rising national standards of the same kind of drug standards, such as has been included in the "Chinese Pharmacopoeia", should be approved by the original drug approval documents to the provincial bureau drug registry for change registration procedures.

Second, for the drug registration standards contained in the test items more than the "Chinese Pharmacopoeia" or the quality index is higher than the "Chinese Pharmacopoeia" requirements, in the implementation of "Chinese Pharmacopoeia" on the basis of the same time should be the implementation of the original standard of the corresponding project And indicators. The pharmaceutical manufacturers should be more serious than the original implementation of the standard and the "Chinese Pharmacopoeia" differences between those who should be related to the relevant items and indicators to provide a detailed description and stamped with the unit seal, and holding drug approval documents The original to the provincial bureau drug registry for change registration procedures. In the preparation of pharmaceutical instructions or labels, the "implementation of standard items" should also be printed on the "Chinese Pharmacopoeia" provisions and more than the "Chinese Pharmacopoeia" or the quality indicators higher than the "Chinese Pharmacopoeia" requirements of the test project name and standard number The

Third, involving the instructions, the label changes, such as the original implementation of the standard only to change the "Chinese Pharmacopoeia" implementation of standards, pharmaceutical manufacturers can only change the implementation of standards and specifications of the revised date of the commitment 2 (provincial and filing enterprises 1 ), And reported to the provincial bureau drug registry for the record, with the previous record of the sample merger, without the need to provide revised samples. The revision date of the manual is October 1, 2010 and can be set to 2010

October 1, 2010; October 1, 2010 after the revision of the actual record date shall prevail. If there are other items to change, according to the State Food and Drug Administration "on the implementation of the <Chinese Pharmacopoeia> 2010 edition of the relevant matters notice" (No. 43, 2010) and the provincial bureau "on strengthening the drug manual and label management issues related to notice "(Su food and drug supervision note [2006] 287) requirements for processing.

The State Food and Drug Administration and the provincial bureau will be opened in the portal on the 2010 edition of "Chinese Pharmacopoeia" column, the various units in the implementation process in case of problems can be exchanged in the column.