Pharmacopoeia Committee: Interpretation of issues related to the implementation announcement of the 2015 edition of the Chinese Pharmacopoeia


Release time:

2015-12-15


All relevant units:
In order to further improve the implementation of the 2015 edition of the Chinese Pharmacopoeia, in consultation with the Department of Drug and Cosmetic Registration Administration of the State Food and Drug Administration, we are now making further explanations and clarification on the relevant issues related to the implementation of the new edition of the Pharmacopoeia fed back by some drug manufacturers and regulatory authorities (see annex), in order to correctly understand and implement the relevant requirements of the State Food and Drug Administration on the implementation of the 2015 edition of the Pharmacopoeia of the People's Republic of China (No. 105 of 2015).
During the implementation of the 2015 edition of the Chinese Pharmacopoeia, all relevant units can feedback the problems encountered and relevant suggestions to our committee at any time. Our committee will give a unified reply in the "2015 edition of Pharmacopoeia implementation column" after consultation with relevant departments.
Announcement on the Implementation of the 2015 Edition of Chinese Pharmacopoeia (I) on the interpretation of relevant issues
1. Q: The announcement of china food and drug administration on matters related to the implementation of the 2015 edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the 2015 edition of the Pharmacopoeia) (hereinafter referred to as the "Announcement") (No. 105 of 2015) stipulates that if a supplementary application is required to comply with the 2015 edition of the Pharmacopoeia, the declaration shall be made before December 1, 2015. Can the corresponding supplementary application still be submitted after December 1, 2015?
Answer: For drugs that have been listed before the release of the 2015 edition of the Pharmacopoeia, manufacturers should complete the research and comparison between the original standard and the relevant requirements of the new edition of the Pharmacopoeia before December 1, 2015, and should make corresponding filing or supplementary declaration according to the requirements of the announcement. After December 1, 2015, the corresponding supplementary application can still be submitted.
2. Q: If the registration standard of the enterprise has already evaluated the relevant varieties of the 2010 edition of the Pharmacopoeia, and there is no change in the quality standards and detection methods of the 2010 edition and the 2015 edition of the Pharmacopoeia, is it necessary to re-evaluate the products?
Answer: Although there is no change in the content of the variety and the variety regulations of the 2015 edition of the Pharmacopoeia, due to the comprehensive revision of the general requirements of the 2015 edition of the Pharmacopoeia, including the general rules, general rules of preparations and general inspection methods, the production enterprises still need to evaluate the product accordingly in terms of the general requirements of the 2015 edition of the Pharmacopoeia.
3. Q: Questions on the way of expressing drug implementation standards
Answer: For products whose registration standards are not lower than those of the Chinese Pharmacopoeia, the registration standards shall be implemented. The implementation standards shall be expressed as follows: "The drug registration standards shall be implemented and shall meet the requirements of the 2015 edition of the Chinese Pharmacopoeia".
4. Q: For imported drug manufacturers, can the letter of explanation issued by the registered agency be used instead of the foreign declaration letter for filing or supplementary application?
A: In principle, the registered agent company should issue a letter of statement from the licensee. If a letter of instruction is used instead of a foreign declaration letter, the power of attorney issued by the imported drug manufacturer to entrust the registration agent company to handle the matter shall be provided at the same time.
5. Q: Announcement No. 67 of 2015 of the State Administration of Food and Drug stipulates that the 2015 edition of Pharmacopoeia will be implemented as of December 1, 2015 ". How to define the execution date of the product?
Answer: According to the implementation practice requirements of the past edition of Pharmacopoeia, drugs produced or imported from December 1, 2015 shall comply with the relevant provisions of the 2015 edition of Pharmacopoeia.
6. Question: Whether the original standard can still be implemented during the review and approval period for varieties that are filed or supplemented according to the requirements of the implementation announcement, and whether new certificates can be issued according to the original registration standard if there are import re-registration applications during the period.
Answer: The applicant shall follow the provisions of paragraph 5 of the implementation announcement No. 105. If there is a cross between the supplementary application and the re-registration application, it is recommended that the supplementary application and the import re-registration be combined for review. If the supplementary application has been submitted before December 1, 2015, the requirements of the original standard can be implemented during the supplementary application period.
7. Q: Does the preparation intermediate also need to be improved according to the pharmacopoeia standard of the preparation?
Answer: According to the needs of the production enterprises, they evaluate the quality standards of the preparation intermediates to ensure that the preparations they produce should meet the requirements of the 2015 edition of the Pharmacopoeia. The preparation intermediates managed according to the approval number must comply with the requirements of Announcement No. 105.
8. Q: If there are multiple dosage forms of the same variety, and some dosage forms have not yet been included in the Pharmacopoeia, do they also need to meet the requirements of the 2015 Pharmacopoeia?
Answer: If there are varieties and different dosage forms contained in the pharmacopoeia, the corresponding national drug standards for the dosage form shall be implemented on the basis of the general requirements of the pharmacopoeia.
9. Q: The testing methods specified in the enterprise registration standards are different from those contained in the 2015 edition of Pharmacopoeia. Can the enterprise registration testing methods be implemented through filing?
A: First of all, the registration standard should conform to the relevant provisions of Article 23 of the 2015 Pharmacopoeia "Every Law. Manufacturers should fully assess the applicability of the two methods and decide on the form of declaration based on the assessment results. If it is necessary to revise the testing method, a supplementary application may be submitted in accordance with the relevant provisions, and after approval by the national drug regulatory department, the testing method of the enterprise registration standard may be implemented.
10. Q: For new drug clinical research applications, according to the current procedural quality standards have not been approved, how should the corresponding update application be carried out?
Answer: According to the sixth paragraph of the implementation announcement No. 105.
11. Q: Does the "prescribed period" in the sentence "drugs produced after the prescribed period must use the changed instructions and labels" refer to what time?
A: It means December 1, 2015.
12. For the same product, in order to meet the requirements of the 2015 Pharmacopoeia, some items need to be applied for supplementary applications, and some items can be filed. Can the production enterprise combine the filing and supplementary applications?
Answer: If the registration application matters for examination and approval and filing are the same examination and approval authority, they can be declared together.
13. According to the general requirements of the 2015 edition of Pharmacopoeia, if new testing items need to be added under varieties and new testing methods need to be established, can the original standards still be implemented during the supplementary application approval period?
Answer: On the premise that the listed drugs meet the requirements of the 2015 edition of the Pharmacopoeia, new inspection methods and supplementary applicants are required. During the review and approval process, enterprises can still implement the original standards.
14. The general rules of four pharmaceutical excipients in the 2015 edition of the Chinese Pharmacopoeia stipulate that "the excipients used in drugs should be written into the drug instructions". How should enterprises implement them?
Answer: Manufacturers should strictly implement the requirements of Article 11 of the "Regulations on the Administration of Drug Instructions and Labels" in Order No. 24 of the State Administration. For drugs that are not clearly specified in Order No. 24, manufacturers are encouraged to list the excipients used in the drugs in the instructions. The Pharmacopoeia Committee will organize experts to formulate and issue relevant guidance documents.
15. The storage conditions are different from the storage conditions of various varieties in the 2015 edition of the Chinese Pharmacopoeia. How to implement the original approved storage conditions?
Answer: If the storage conditions of the original registration standard are maintained, they should be filed with the provincial bureau. If the storage temperature is changed to the new pharmacopoeia variety, the manufacturer shall submit a supplementary application based on the product stability verification data and implement it after approval.
16. Issues Concerning the Implementation of the 2015 Edition of the Chinese Pharmacopoeia
Answer: According to the State Food and Drug Administration's "Announcement on Issuing the Pharmacopoeia of the People's Republic of China (2015 Edition)", the 2015 edition of the Chinese Pharmacopoeia will come into effect when it is officially released on June 5, 2015. The transition period from the date of release to the date of implementation of the new pharmacopoeia. During this period, the drug production and inspection agencies can implement the original pharmacopoeia standards, or they can implement the standards in line with the new version of the pharmacopoeia after revision. On December 1, 2015, the relevant provisions of the 2015 edition of the Pharmacopoeia shall be implemented.
17. Implementation of Chinese Pharmacopoeia for Hospital Preparations
Answer: The preparations configured by medical institutions should meet the basic requirements of the "Chinese Pharmacopoeia" as much as possible. Taking into account the particularity of hospital preparations, according to the preparation situation, the relevant provisions of the "Chinese Pharmacopoeia" can be gradually implemented.
18. On the issue of changing the standard of pharmaceutical excipients into excipients for injection
Answer: The pharmaceutical excipients (available for injection) contained in the 2015 edition of the Pharmacopoeia are the division of different grades and specifications of the same pharmaceutical excipients. If a manufacturer uses pharmaceutical excipients available for injection, it does not involve changes in the types of excipients. On the basis of meeting the applicability requirements of pharmaceutical excipients, changes can be made through filing.