State Food and Drug Administration to implement the announcement
Notice of the State Administration of Food and Drug Administration on the Implementation of the relevant edition of the People's Republic of China Pharmacopoeia 2015 edition (No. 105 of 2015)
"People's Republic of China Pharmacopoeia" (hereinafter referred to as "Chinese Pharmacopoeia") 2015 edition has been issued by the State Food and Drug Administration No. 67 Announcement 2015, from December 1, 2015 onwards. The relevant matters concerning the implementation of the Chinese Pharmacopoeia 2015 edition are as follows:
First, the "Chinese Pharmacopoeia" is the drug development, production (import), management, use and supervision and management of relevant units should follow the statutory technical standards.
Second, the "Chinese Pharmacopoeia" 2015 edition, including the case, the text and general rules, since the date of implementation, all production of listed drug standards (including drug registration standards) should be the implementation of the Pharmacopoeia of the relevant general requirements.
三、Where the "Chinese Pharmacopoeia" 2015 version of the collection of species, since the date of implementation, the original contained in the Pharmacopoeia Pharmacopoeia, Bureau (Department) awarded the same type of national drug standards at the same time abolished.
Where the "Chinese Pharmacopoeia" 2015 edition under the variety of products not contained specifications, the quality standards according to the version of "Chinese Pharmacopoeia" with the relevant requirements of the implementation of the specifications, according to the original approval documents.
Where the "Chinese Pharmacopoeia" 2015 edition is no longer contained in the calendar Pharmacopoeia has received varieties (due to security, effectiveness and other issues withdrawn from the city except), the new standard is not promulgated before the implementation of the original Pharmacopoeia standards, but should be consistent with the new version General requirements for pharmacopoeia.
四、Drug registration standards in the collection of test items more than (including different) Pharmacopoeia requirements or quality indicators strict pharmacopoeia requirements, the implementation of pharmacopoeia requirements should be based on the implementation of the original registration standards of the corresponding projects and indicators. Due to differences in materials and production processes lead to differences in testing items, production enterprises should be based on scientific, quality control of the principles of research, if necessary, to declare drugs to apply.
If the drug registration standard is less than the requirements of the Pharmacopoeia or the quality index is lower than the requirements of the Pharmacopoeia, the Pharmacopoeia shall be implemented.
五、"Chinese Pharmacopoeia" 2015 version of the date of release (including the date) before the approved drugs should be December 1, 2015 from the implementation of the new Pharmacopoeia corresponding requirements. In case of alteration of pharmaceutical prescription, raw and auxiliary materials and production technology, it shall, in accordance with the Measures for the Administration of Drug Registration, submit a supplementary application to the State Food and Drug Administration before December 1, 2015, and the examination and approval period The original standard, approval by the implementation of the new standards, approval should not immediately stop production.
Only concerned with the detection of the project, the index limit adjustment but does not involve the drug prescription, raw and auxiliary materials, production and process changes, should be implemented before the date of the provincial food and drug supervision and management departments (imported drugs reported to the State Food and Drug Administration) Filing.
六、The new drug registration application should be carried out in accordance with the relevant requirements of the new Pharmacopoeia. The technical review department shall conduct a review in accordance with the relevant requirements of the new Pharmacopoeia. Those who meet the requirements are not approved.
The technical review department has not yet completed the relevant technical review of the registration application, in accordance with the relevant requirements of the new Pharmacopoeia review; technical review departments have completed the relevant technical review of the Chinese Pharmacopoeia 2015 version of the date of publication (including the date) The registration application, drug approval within 6 months after listing should meet the relevant requirements of the new Pharmacopoeia.
七、According to the "Chinese Pharmacopoeia" 2015 edition of the revised content, pharmaceutical manufacturers should be in the above-mentioned period before the "Drug Registration Management" provides timely changes in the instructions and labeling of pharmaceutical applications. Drugs produced after the specified period of time must use the revised instructions and labels. For the generic name of the drug has been revised, its original name can be used as a transitional use of the name.
八、Pharmaceutical production (import) enterprises should actively do a good job in the implementation of the "Chinese Pharmacopoeia" 2015 edition of the preparatory work for the implementation of the new Pharmacopoeia in the implementation of the problems found in the local newspaper and provincial food and drug supervision and management departments, and should continue to improve the quality control and quality Standard research, and continuously improve the level of drug quality control.
九、The provincial food and drug supervision and management departments should cooperate with the "Chinese Pharmacopoeia" 2015 version of the publicity and implementation of the new version of the Pharmacopoeia to strengthen the supervision and guidance, timely collection and feedback related issues and opinions.
十、The National Pharmacopoeia Commission is responsible for organizing and coordinating the implementation and training of the Chinese Pharmacopoeia 2015 edition and the specific technical guidance in the implementation of the new Pharmacopoeia. In its website specifically to open up the "Chinese Pharmacopoeia Executive Column", in a timely manner to answer all the relevant issues reflected, and timely organization of the new version of the implementation of the special assessment and inspection.
Special announcement.
Attachment: 1. "Chinese Pharmacopoeia" 2015 version by the revised catalog
2."Chinese Pharmacopoeia" 2015 version is no longer contained varieties directory
Food and Drug Administration
July 15, 2015