China CFDA releases 2016 Drug Review Annual Report

China Food and Drug Administration (CFDA) recently released the 2016 Drug Review Annual Report. The Annual Report describes the general situation of drug registration acceptance, review and approval in 2016, and analyzes the data of acceptance and review in 2016 for chemical drugs, traditional Chinese medicines and biological products respectively.

China issues five-year plan on food and drug safety

Two five-year plans (2016-2020) on food and drug safety were issued by the State Council on Feb 21.

According to the food safety plan, China will set stricter standards as well as strengthen supervision and punishment for law violators.

The plan outlines that by 2020 sample tests should cover all kinds of food, especially pesticides and veterinary drugs.

The plan on drug safety outlines that by 2020 the quality of drugs should be further improved, the standard of medical equipment will be raised and the level of supervision will be enhanced.

More information is available from Brückenkopf GmbH website.

CFDA Official Explains the Verification of New Drug Clinical Trial Data

An official from the Department of Drug and Cosmetics Registration of CFDA was interviewed about “the issues on authenticity of clinical trial data in new drug registration applications” reported by media.

The official introduced that according to the Announcement on Performing Self-Examination & Verification of Drug Clinical Trial Data issued on July 22, 2015 by CFDA, for 1622 registration applications for marketing and import, the applicants had been required to do self-examination on the authenticity, integrity and compliance of clinical trial data. Deducting 193 registration applications exempted from clinical trial, the total number of applications for self-examination was 1429. Applicants could voluntarily withdraw their registration applications with problematic clinical trial and reapply after supplementing their dossiers. By the end of June, 2016, 1193 voluntary withdrawals happened after self-examination of the companies, accounting for 83% of the total number of registration applications for self-examination.

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The 7th China International Medical Device Regulatory Forum held in Chengdu

On September 11-13, 2016, the 7th China International Medical Device Regulatory Forum was held in Chengdu, China. Jiao Hong, Vice Minister of China Food and Drug Administration (CFDA) attended and addressed the opening ceremony of the forum.

With the theme of “standardizing medical device clinical trials, guaranteeing the authenticity of clinical data,” the forum invited domestic and foreign experts to give keynote speeches, and set up more than ten sub-forums on regulatory and industry hot topics, including forums on medical device innovation and post-market surveillance. Directors from CFDA’s medical device regulatory departments and technical institutions interpreted related policies, laws, regulations and technical requirements of China. Experts from domestic and foreign medical device regulatory and technical departments and medical device industry exchanged latest information on medical device related regulations, new products and new technologies.