Medical network - on November 30, for the implementation of the state council general office on the evaluation opinions of generic quality and curative effect of consistency "(countries do hair [2016] no. 8)," about the implementation of the general office of the state council about to carry out the quality of generic drugs and curative effect evaluation opinion consistency > announcement of relevant matters of (state administration of food and drug supervision and management of the announcement no. 106 2016) of the relevant requirements, the state food and drug supervision and management of administration organization drafted the generic quality consistency and efficacy evaluation variety classification guidance (draft) ", is to solicit opinions from the public. Please make amendments on December 31, 2016 by email feedback to the administration of state food and drug supervision and administration.
Email: fzy@nifdc.org.cn
Attachment: the quality of generic drugs and curative effect evaluation consistency varieties classification guidance (draft)
The food and drug supervision administration office
On November 29, 2016
The attachment
Generic drug quality and consistency evaluation of curative effect
Varieties classification guidance
(draft)
In order to further promote the quality of generic drugs and curative effect evaluation consistency (hereinafter referred to as the consistency evaluation) work, is now about 289 varieties classification the following guidelines:
One, the original imported varieties. Don't need to carry out the consistency evaluation, the quality of generic drugs and curative effect evaluation expert committee review to determine consistency and the food and drug supervision bureau is released, can choose for the reference preparation.
Second, the original enterprise production listed within the territory of China
(a) listed according to in line with the original drug quality and curative effect before report and review of principle, can be listed as reference. By enterprises within the prescribed time, consult the generic chemical medicine oral solid preparation quality and curative effect evaluation declaration data consistency requirements (try out) ", submitted to the food and drug supervision bureau consistency evaluation office sex related information and documents. Consistency evaluation office to arrange the food and drug supervision administration of drug approval center (hereinafter referred to as the center of human medicinal) review and issue the opinion, need to develop the site inspection, production site inspection and verification of clinical trials, put forward by the human medicinal center, food and drug supervision administration of the food and drug concrete implementation audit inspection center, and feedback to the center of human medicinal. On the basis of human medicinal center, consistency evaluation office for examination and approval opinions, the food and drug supervision bureau for examination, verification and release. The submitted data is not enough to prove in line with the original drug quality and curative effect, can supplement relevant experimental study.
(2) according to in line with the original drug quality and curative effect of report and review of principle, in accordance with the relevant regulations, to carry out the consistency evaluation.
Three, imported generic varieties. Before listing in accordance with the principle of in line with the original drug quality and curative effect of declaration and review, in accordance with the procedures prescribed in paragraph 1 of article 2 of the above; Pre-ipo fail to in line with the original drug quality and curative effect of report and review of principle, to carry out consistency evaluation in accordance with relevant regulations.
Four, domestic generic types. Before listing in accordance with the principle of in line with the original drug quality and curative effect of declaration and review, in accordance with the procedures prescribed in paragraph 1 of article 2 of the above; According to in line with the original drug quality and curative effect of report and review of principle, in accordance with the relevant regulations, to carry out the consistency evaluation.
Five, the dosage forms, specifications, change is to change the base of generic varieties
Should be in accordance with the food and drug supervision bureau issued guidelines related to carry out conformity assessment.
(a) change specifications varieties. In accordance with the quality of generic drugs and curative effect evaluation to change specifications and general consideration of drug evaluation consistency (stay) request, does not change the indication, usage, dosage, and within the scope of the therapeutic dose, drug has linear pharmacokinetic characteristics, in order to change specifications of drugs and reference preparation in the same dosage of medicine (single drug dose not exceed the maximum dose dose), bioequivalence test; Does not meet the above conditions, should refer to "generic quality consistency and curative effect evaluation of clinical efficacy test generally considered (to be released, hereinafter referred to as clinical effectiveness test generally consider) requirements, carry out experimental study clinical efficacy.
(2) to form varieties. In accordance with the generic quality consistency evaluation of the effect of change of dosage form drug (normal) oral solid preparations evaluation generally considered "(no. 2016, XX, to be published) requirements, to the biological equivalent for LiTi basis and does not significantly change the pharmacokinetic behavior of the change of dosage form drugs, dosage forms and the original reference preparations bioequivalence test; To change the change of dosage form drug pharmacokinetic behavior, with the original dosage form reference relative bioavailability studies, and with reference to clinical efficacy test generally consider, carry out experimental study clinical efficacy.
(3) the variety of change the base. In accordance with the quality of generic drugs and curative effect evaluation of consistency in the change of base medicines evaluation generally considered "(stay), with equivalent for LiTi basis of drugs, to carry out the change and the base medicines for the bioequivalence study of reference preparations; With superior effect for LiTi basis of medicine, to be change base drugs as reference preparations, pharmacokinetic study, and reference to clinical efficacy test generally consider, carry out experimental study clinical efficacy.
Six, domestic unique, dietary supplements, such as adjuvant therapy varieties. Species list, issued by the food and drug supervision administration and evaluation institutions such as the common research methods will be in the same industry association, the committee of experts after argument, shall be issued separately.
Generic drug quality and curative effect evaluation of consistency is a huge social system engineering, the food and drug supervision bureau attaches great importance to this, the problems encountered in the process of work of the enterprise will further strengthen guidance. |
