China Association for Medical Devices Industry (CAMDI) - CFDA has therefore issued General Considerations of Evaluation on Modified Dosage-Form Drugs (Common Oral Solid Dosage) in Consistency Evaluation of Generic Drug Quality and Efficacy (Exposure Draft).

To execute Opinions of the General Office of the State Council on Consistency Evaluation of Generic Drug Quality and Efficacy (Guo Ban Fa [2016] No. 8) and Execution of ‘Opinions of the General Office of the State Council on Consistency Evaluation of Generic Drug Quality and Efficacy’ (China Food and Drug Administration 2016 No. 106), China Food and Drug Administration has drafted General Considerations of Evaluation on Modified Dosage-Form Drugs (Common Oral Solid Dosage) in Consistency Evaluation of Generic Drug Quality and Efficacy (Exposure Draft) and now is soliciting opinions from the general public. Please report suggestions on revision back to CFDA via e-mail by December 1, 2016.

E-mail: ylqxzc@sina.cn.

Annex: General Considerations of Evaluation on Modified Dosage-Form Drugs (Common Oral Solid Dosage) in Consistency Evaluation of Generic Drug Quality and Efficacy (Exposure Draft)

General Office of China Food and Drug Administration

November 4, 2016

CFDA has therefore issued General Considerations of Evaluation on Modified Dosage-Form Drugs (Common Oral Solid Dosage) in Consistency Evaluation of Generic Drug Quality and Efficacy (Exposure Draft).

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