China Lifesciences Monthly Update - June/July 2016

Drug Tracing System replaces Drug Electronic Supervision System in China, 13 July 2016

The China Food and Drug Administration ("CFDA") has issued the revised Good Supply Practice for Pharmaceutical Products (“GSP”). This updated GSP requires the distributor to build up a Drug Tracing System which can be used to search for, and find information on, the source of drugs, distribution of drugs and responsible parties. It has also set out stricter requirements on the personnel and equipment involved in storage, transport and supply of vaccines and drugs which require refrigeration.

CFDA further confirmed the implementation of MAH system, 7 July 2016

The CFDA has issued a notice to all of its local branches to give further instructions on implementing the Pilot Drug Marketing Authorisation Holder (“MAH”) system which was formulated in the Circular on the Pilot Program for the Drug Marketing Authorisation Holder System. During the pilot term (from 26 May to 4 November 2018), for qualified drugs, qualified drug R&D institutions and individuals in ten pilot areas can apply for a drug licence and to become a MAH. The applicant and holder will be liable for the clinical trial, drug registration, manufacturing and marketing processes. Qualified authorised manufacturing enterprises will be liable for the manufacturing process. The registration approval process is the same as the normal drug registration process.

CFDA Solicits Public Opinion on the Prior Approval Process for Medical Devices, 21 June 2016

The CFDA has issued the Circular Regarding Soliciting Comments Regarding Priority Review Designation Procedure for Medical Devices which recently closed for public comment on 20 July 2016. This Draft lists several circumstances under which medical devices can enjoy prior approval, which includes devices assessed as national major science and technology projects or key research and development programs; or devices which have brought about an obvious improvement in curing rare, difficult, elderly related or child related illnesses. The Draft also clarifies the relevant procedures and corresponding responsible government departments.

New Regulation on Vaccine Circulation and Preventive Inoculation, 14 June 2016

The CFDA and the National Health and Family Planning Commission (“NHFPC”) has jointly issued the revised Administrative Regulations on the Circulation of Vaccines and Vaccinations, which came into force as of the date of promulgation. According to the Regulation, overseas vaccine enterprises which export vaccines into China should find a Chinese agent to sell their vaccines and take on all of the responsibility under the Regulation on behalf of the foreign company, including for the quality of the vaccine. The agent is required to make record their activities with the local provincial FDA.

Stricter Approval Process for Baby Formula Products, 8 June 2016

The CFDA has issued the Administrative Measures for Registration of Baby Formula Products which will come into force on 1 October 2016. The Measure mainly details the requirements for the application, evaluation and approval process; the on-site investigation; and the renewal process. It also requires that the labels and instructions should be consistent with the content approved; misleading content, such as a claim regarding the healthcare function of the product or that it will increase resistance or immunity and protect intestinal functions, is prohibited; and the country of origin must be specified if the products are imported from overseas.

New measures for communication with CDE, 2 June 2016

The CFDA has issued the Administrative Measures for Communication on Research, Development and Technical Evaluation of Drugs which came into force as of the date of promulgation. "Communication" is defined as being between drug registration specialists and the Centre of Drug Evaluation’s (“CDE”) project manager and concerns key technical issues that are not included in existing guidebooks for drug research, development and evaluation. The Measure defines the types of communication meetings, procedures and requirements for the proposal, preparation, convening, postponement or cancellation of a communication meeting.