Opinions of the General Office of the State Council on Conducting the Consistency Evaluation of the Quality and Efficacy of Generic Drugs
Opinions of the General Office of the State Council on Conducting the Consistency Evaluation of the Quality and Efficacy of Generic Drugs
Opinions of the General Office of the State Council on Conducting the Consistency Evaluation of the Quality and Efficacy of Generic Drugs
Guo Ban Fa [2016] No.8
February 6, 2016
The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, and all ministries ,commissions and organizations directly subordinate to the State Council,
The work of conducting the consistency evaluation of the quality and efficacy of generic drugs (the "consistency evaluation") has great significance for promoting the national pharmaceutical industry, ensuring safety and efficacy of drugs, facilitating the upgrading and restructuring of the pharmaceutical industry and enhancing international competitiveness. In accordance with the Opinions of the State Council on the Reform of Evaluation and Approval System for Drugs and Medical Devices(Guo Fa [2015] No.44), these Opinions are hereby promulgated for conducting the consistency evaluation with the approval from the State Council:
I. Defining evaluation objects and time limit. The generic drugs, which have been approved for marketing before the implementation of new registry classification of chemical drugs, shall be subject to the consistency evaluation provided that they have not undergone review and approval according to the principle of consistency with the quality and efficacy of brand-name drugs. With respect to the oral solid preparations of chemical generic drugs on the National Essential Medicine List (2012 edition) which have obtained approval for marketing prior to October 1, 2007, the consistency evaluation shall be completed by the end of 2018.
......
Guo Ban Fa [2016] No.8
February 6, 2016
The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, and all ministries ,commissions and organizations directly subordinate to the State Council,
The work of conducting the consistency evaluation of the quality and efficacy of generic drugs (the "consistency evaluation") has great significance for promoting the national pharmaceutical industry, ensuring safety and efficacy of drugs, facilitating the upgrading and restructuring of the pharmaceutical industry and enhancing international competitiveness. In accordance with the Opinions of the State Council on the Reform of Evaluation and Approval System for Drugs and Medical Devices(Guo Fa [2015] No.44), these Opinions are hereby promulgated for conducting the consistency evaluation with the approval from the State Council:
I. Defining evaluation objects and time limit. The generic drugs, which have been approved for marketing before the implementation of new registry classification of chemical drugs, shall be subject to the consistency evaluation provided that they have not undergone review and approval according to the principle of consistency with the quality and efficacy of brand-name drugs. With respect to the oral solid preparations of chemical generic drugs on the National Essential Medicine List (2012 edition) which have obtained approval for marketing prior to October 1, 2007, the consistency evaluation shall be completed by the end of 2018.
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