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China FDA issues draft guidance on drug review and approval transparency Posted 02/02/2018

China Food and Drug Administration (CFDA) announced on 16 January 2018 that it had issued draft guidance on the public disclosure of information related to its review and approval of drug applications.

The draft guidance has been issued as part of CFDA’s (simplified Chinese: 国家食品药品监督管理局) implementation of the Chinese Government’s call for greater transparency.

According to the draft guidance, the agency is responsible for disclosing information regarding an application’s acceptance, the review and approval process and result of the review via a public drug trial centre portal. The drug trial centre will create a review system to make decisions on what information should be made public and to ensure that proprietary information, such as trade or technical information, remains confidential.

The drug trial centre has a 10-working-day timeline after the beginning of a review to make public the application number and CFDA acceptance date. In addition, the product name and whether it is a traditional Chinese medicine, chemical entity or biological will also be disclosed. The centre will also explain priority review decisions.

For newly approved drugs and generics, review information will be made public within 60 days following approval. The information will include active ingredients, dosing, license holder, patents and an experimental data protection period.

The drug trial centre will also periodically summarize and make public information on common quality issues identified in applications, analyse repetitive applications and highlight products that have more than three applications for a similar drug type. Any major technical disputes between the applicant and reviewers will also be made public.

Finally, in the first quarter of each year, the drug review centre will produce a drug review report for the previous year, which will include a drug review summary and timeline evaluation.

Comments on the draft guidance are due by 21 February 2018.

This kind of transparency has not been seen before in China and will surely be welcomed. Data released by CFDA revealed that between January 2015 and January 2016 the agency rejected or withdrew more than 80% of drug applications due to incomplete or fraudulent clinical data [1].

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1. GaBI Online - Generics and Biosimilars Initiative. China’s CFDA rejects more than 80% of drug applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from: www.gabionline.net/Pharma-News/China-s-CFDA-rejects-more-than-80-of-drug-applications

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Source: CFDA

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