China Lifesciences Monthly Update – August/September 2016

Administrative Measures for Drug Registration (Draft Revision) issued by CFDA, 25 July

The China Food and Drug Administration (CFDA) has released the Administrative Measures for Drug Registration (Draft Revision) which closed for public comment on 26 August. The Draft introduces several communication processes, and dispute resolution and information publication regimes which aim to improve the efficiency of the approval process and reduce the corresponding approval period.

Good Laboratory Practice for Non-clinical Laboratory Studies issued by CFDA, 19 August

The CFDA has issued the draft Good Laboratory Practice for Non-clinical Laboratory Studies (GLP) for public comments to be submitted by 18 October. This document contains twelve chapters and mainly sets out the definitions of certain terminologies, standards of practice, implementation of the research, management of documents as well as requirements for the staff, facilities and experiments.

CFDA to complete legal framework for food and drug regulation by 2020, 8 August

The CFDA issued the Implementing Opinions on Comprehensively Strengthening the Rule of Law Construction in the Food and Drug Administration System on 8 August. The Opinion includes eight key tasks: accelerating the food and drug regulatory law system construction; implementing the streamlining government and optimisation of service; making administrative decision-making more scientific and democratic; adhering to strict, standardised and fair law enforcement; promoting food and drug legal education; effectively resolving social conflicts and disputes and improving the administrative capacity of the law enforcement officers.

Administrative Measures for Medical Device Recall (Draft for Comment) issued by CFDA, 1 September

The CFDA issued the Administrative Measures for Medical Device Recall (Draft for Comment) on 1 September to solicit public opinions by 30 September. The Draft aims to strengthening the supervision and administration of medical devices, and improving the safety and effectiveness of medical devices. The draft stipulates the definition of “medical device recall”, applicable circumstances of recall, the legal liabilities of relevant parties and two types of recall procedures: voluntary recall conducted by the manufacturers and compulsory recall ordered by the food and drug administration.

Authorities to take Joint Disciplinary Action against violator in Food and Drug industry, 13 September

To establish and improve the joint disciplinary action in the food and drug industry, the CFDA and 27 other departments jointly issued the Memorandum of Cooperation in a Joint Disciplinary Action against Food and Drug Manufacturers and Business Operators with Serious Discreditable Conduct on 13 September. The Memorandum specifies the manufacturer, business operator and their executives would be the target of the actions. It also clarifies that CFDA will restrict the violator in its relevant business operation, while other authorities will restrict the violator’s ability to get a loan, to be listed on the security market and attend government purchasing biddings.