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NMPA Issued the Announcement on the Selection and Determination Procedures for Reference Formulation



To standardize the review and consistency evaluation of generic drugs, optimize work procedures, strengthen service guidance, and ensure fairness, impartiality, and openness Supplementary Rules. The Measures contains a total of 11 Articles, which set clear requirements for the organization and implementation units, time, subjects, exemption conditions, periods, disciplines and other aspects of the Examination. (March 20, 2019) thereof, NMPA has organized the formulation of the Procedures for the Selection and Determination of Reference Formulations of Chemical Generic Drugs, which has been released and in force on March 28, 2019, upon which the Announcement on the Procedures for Filing and Recommendation of Reference Formulations for Consistency Evaluation of the Quality and Efficacy of Generic Drugs (CFDA Announcement No. 99, 2016), promulgated by the former China Food and Drug Administration, has been repealed simultaneously. The relevant provisions of the present Announcement shall prevail over those previously announced, where discrepancies arise.. 

(March 28, 2019)