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Generic drug quality and efficacy of consistency assessment of species classification guidance was released

  • Categories:Industry News
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  • Time of issue:2017-04-06 00:00
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Generic drug quality and efficacy of consistency assessment of species classification guidance was released

Information

In order to standardize the evaluation of the consistency of the quality and efficacy of generic drugs, the State Food and Drug Administration has formulated the Guiding Opinions on the Classification of Varieties for the Evaluation of Consistency and Quality of Generic Drugs, and released it.

Generic drug quality and efficacy of consistency assessment of species classification guidance

To further promote the quality of medicines and the efficacy of consistency assessment (hereinafter referred to as the consistency assessment) to carry out the work, the classification of the species now make the following guidance:

First, the original research imported varieties. Consistency without the need for evaluation, the State Food and Drug Administration audit confirmed and released, you can choose as a reference preparation.

Second, the original research enterprises in China's production and marketing of varieties. Original research enterprises in the production and marketing of varieties in China, the State Food and Drug Administration approval to determine the release, you can choose as a reference preparation.

Third, the import of imitation varieties.

(A) prior to listing According to the principle of consistent with the original drug quality and efficacy of the declaration and review of the application submitted by the enterprise, the State Food and Drug Administration Administrative Services and Complaints Reporting Center to receive information, the State Food and Drug Administration drug trial Assessment Center review and make comments, submitted to the State Food and Drug Administration released.

(B) before listing in accordance with the original drug quality and efficacy consistent with the principle of reporting and review, according to the relevant provisions of the consistency assessment.

Fourth, the domestic imitation varieties. To be declared and reviewed according to the principle of consistent with the original drug quality and efficacy prior to listing, the drug shall be administered in accordance with the procedures set forth in the first paragraph of Article 3 of the preceding Patent Law. If the drug is not declared and reviewed in accordance with the principle of consistent quality and efficacy of the original drug, Conduct a consensus assessment.

Fifth, change the specifications, change formulations, to change the salt-based imitation varieties. According to the General Administration of Food and Drug Administration issued a "generic drug quality and efficacy of the same assessment of the change in the standard drugs (oral solid preparations) evaluation of general considerations," "generic drug quality and efficacy of conformal assessment of the work of modified drugs (oral solid Preparation) Evaluation General considerations "" generic quality of medicines and efficacy of the consensus assessment of salt-based pharmaceutical evaluation of general considerations "and other guidelines for consistency assessment.

Sixth, the domestic unique varieties. The enterprise may choose to re-run clinical trials to prove its safety and effectiveness, and submit the application according to the Requirements for the Application of Consistency Evaluation of Quality and Efficacy of Oral Solid Preparations of Generic Drugs (for Trial Implementation). Subsequent review and approval are deemed to be consistent with the assessment of conformity ; Enterprises did not choose to re-run clinical trials, the State Food and Drug Administration announced the lack of validity of its data, is not recommended.

Seven, in case of major technical issues and differences of opinion, held expert committee argument.

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