China Life Sciences & Healthcare Monthly Update – Spring 2018

China

The CFDA further cracking down on food safety issues, 21 March

The China Food and Drug Administration (“CFDA”) announced that it will take serious measures to crack down on food safety issues, particularly on the issues of false adverting and adding medicines or non-edible substances to food etc. The CFDA also emphasised the distributor’s obligation to keep a track record of distributed food. Any enterprises who know that there are counterfeits of their products that they have not reported to the authorities, may be liable if consumers are damaged by such counterfeits.

New regulatory authorities for the Life Sciences and Healthcare sectors, 17 March

The 13th National People’s Congress passed the Programme of Reforming the Institutions of the State Council on the 17 March 2018. The CFDA will be merged into a new authority called the State Administration for Market Supervision. The National Health and Family Planning Commission will be merged into the new National Health Commission. The State Medical Insurance Bureau will be established to administrate all medical insurance related matters.

The CFDA solicits public comments to regulate Internet pharmacies, 9 February

The CFDA announced the Circular on the Measures for the Supervision and Administration of Online Drug Sales (“Draft”). Under the Draft, manufacturers, wholesalers and retailers should obtain a Drug Manufacturing License or Drug Trading License to do business online. Only retailers are allowed to sell medicines to patients directly. Internet pharmacies (including third-party platforms) must have sufficient control systems regarding: cybersecurity, database management, proper drug delivery, drug safety, pharmaceutical consulting and ADR reporting.

The CFDA solicits public comments on infant formula food regulation, 30 January

The CFDA published the Circular on Seeking Public Comments on the Administrative Measures for the Record-filing of Infant Formula Foods (“Draft”). Under the Draft, manufacturers should record with the authority: the raw and auxiliary materials, additives, formula, and labels of infant formula food, before they begin manufacturing the food. If the filing materials are complete, the authority will approve the recording within five days, and then publish the recording information within fifteen days. The technical guidelines to labels and instructions of infant formula food are the same as those for infant formula milk powder.

Overseas Clinical Trial Data of Medical Devices will be accepted by the CFDA, 10 January

The CFDA announced the Technical Guidelines on the Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices (“Guidelines”) on the 10 January 2018. The Guidelines apply when applicants use overseas clinical trial data for the registration of medical devices or in-vitro diagnostic reagents. Applicants should clarify the ethical standards that they followed and prove that their trials essentially conform to China’s Good Clinical Practice for Medical Device Trials. They must ensure that their overseas data is complete, reliable and true. During the technical review, the authority will comprehensively evaluate the validity of the trial and take account of the differences between the research subjects and Chinese subjects.