News

Generics Consistency Evaluation of the Quality and Efficacy

  • Author:Jane
  • Source:CFDA
  • Release on :2017-04-06

In order to standardize generics consistency evaluation of the quality and efficacy, China Food and Drug Administration has formulated the Guidance Opinions on the Classification of Varieties of Varieties and the Consistency of Efficacy.

announce.

China Food and Drug Administration

March 28, 2017

Attached:
Generics Consistency Evaluation of the Quality and Efficacy

Category classification guidance

To further promote the quality of generics and efficacy evaluation (hereinafter referred to as consistency evaluation) work carried out, the classification of the situation is the following guidance:

First, the original research import varieties. Without the need for consistency assessment, China Food and Drug Administration to determine the release of the selected, the choice for the reference preparation.

Second, the original research enterprises in China production and marketing varieties. The original research enterprises in China, the production of listed varieties, the State Food and Drug Administration to determine the release of the approval, the choice of reference formulations.

Third, imports of generic varieties.

(A) before the listing in accordance with the original drug quality and efficacy consistent with the principle of declaration and review, by the enterprise to submit an application, Administrative Services and Complaints Center of CFDA receive information, CFDA's Drugs Assessment center and comments, reported to the State Food and Drug Administration issued.

(B) before the listing did not follow the original drug quality and efficacy consistent with the principle of declaration and review, according to the relevant provisions of the consistency assessment.

Fourth, the domestic generic varieties. Before the listing in accordance with the original drug quality and efficacy consistent with the principle of declaration and review, in accordance with the provisions of the third paragraph of the above procedures; not in accordance with the original drug quality and efficacy consistent with the principle of declaration and review, in accordance with the relevant provisions Conduct consistency assessment.

Five, change the specifications, change the dosage form, change the base of the imitation varieties. According to China Food and Drug Administration issued the "generic drug quality and efficacy of the consistency of the work of the specifications of drugs (oral solid preparations) evaluation of the general consideration" "generic drug quality and efficacy of the consistency of the assessment of drugs in the form of drugs (oral solid Preparation) evaluation of the general consideration "" generic drug quality and efficacy of the evaluation of the work of salt-based drug evaluation of the general consideration "and other guiding principles to carry out consistency evaluation.

Six, the domestic unique varieties. By the enterprise to re-develop clinical trials to prove its safety and effectiveness, and with reference to "chemical generic drugs oral solid preparation quality and efficacy of the consistency of the declaration of data requirements (test)" to submit an application, follow-up review through the consistency assessment ; Enterprises did not choose to re-carry out clinical trials, the State Food and Drug Administration announced its lack of effective data, is not recommended.

7, in case of major technical issues and differences of opinion, held expert committee demonstration.