Public Comments Sought by the General Office of the China Food and Drug Administration on the Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Comment)
Public Comments Sought by the General Office of the China Food and Drug Administration on the Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Comment)
Public Comments Sought by the General Office of the China Food and Drug Administration on the Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Comment)
June 8, 2017
In order to implement the spirit of the Opinions of the General Office of the State Council on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Guo Ban Fa [2016] No.8), the China Food and Drug Administration made partial adjustments to the consistency evaluation of the quality and efficacy of generic drugs, organized to draft the Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Comment) in the light of the previous work progress, and hereby seek public comments. Please give feedback on revision opinions by sending email to the China Food and Drug Administration prior to July 9, 2017.
Email: ygb@cfda.gov.cn
Appendices: 1. Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Comment)
In order to carry out the consistency evaluation of the quality and efficacy of generic drugs (the "Consistency Evaluation"), the related issues are hereby announced as follows:
I. In order to facilitate enterprises' choices of reference products, the Consistency Evaluation Office of the China Food and Drug Administration drew up the list of 289 drug varieties of brand-name drug manufacturers attached to the Announcement on Matters Concerning the Implementation of the Opinions of the General Office of the State Council on the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Announcement of the China Food and Drug Administration [2016] No.106) and published the list to the society as future reference for enterprises to choose reference products. The list is categorized as the list of drugs coming on the market within the territory of China and the list of drugs failing to come on the market within the territory of China. Enterprises are recommended to choose one drug as reference product for putting on record in the following sequence:
1. Brand name drugs: Imported brand-name drugs, drugs which are manufactured and put on the market by brand name enterprises within the territory of China and non-imported brand-name drugs;
2. Drugs which are approved to come on the market in the United States, Japan and the European Union and are certified as reference products under the circumstance where brand name manufacturers cease production.
II. All the reference products reported by enterprises to the Consistency Evaluation Office of the China Food and Drug Administration ("CFDA") for putting on record shall be publicized to the society and the Consistency Evaluation Office of the CFDA shall provide guiding opinions in the light of the following different situations:
1. The drugs can be confirmed to meet the conditions for reference products;
2. There are doubts on whether the drugs meet the conditions for reference products;
3. The drugs obviously fail to meet the conditions.
The enterprises shall make a decision on whether to continue to conduct researches or re-choose reference products at their discretion and assume the corresponding responsibilities.
III. Where enterprises procure reference products abroad on their own, they need to furnish proof of purchase, product packaging, instructions and other materials when submitting their Consistency Evaluation information, or adopt other adequate means to prove that the reference products in use are products of enterprises indicated on the documents. Where enterprises identify that the reference products in use are counterfeited, they shall suspend the research work in progress and submit a report to the Center for Drug Evaluation of CFDA; where the regulatory authorities detect that the reference products used by enterprises are counterfeited, they shall timely notify the relevant enterprises and suspend evaluation and approval at the same time. With respect to the drugs approved to come on the market, the regulatory authorities shall revoke approval documents and publish information to the society, order enterprises to make explanation, open a file on the case and investigate the case in the light of the actual situation.
IV. The bio-equivalence testing institutions shall be subject to the administration through the establishment of the record-filing system in accordance with the Several Opinions of the General Office of the State Council on Further Reforming and Improving the Policies for Manufacturing, Circulating and Utilizing Drugs (Guo Ban Fa [2017] No.13). The bio-equivalence test in the Consistency Evaluation may be carried out by the certified clinical trial institutions or other qualified institutions. The bio-equivalence testing initiators may engage a third party with the required assessment capability to undertake an assessment of the bio-equivalence testing institutions in compliance with the requirements of Good Clinical Practice (GCP).
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