The long awaited and wide-ranging Opinions on Reforming the Review and Approval Process for Drugs and Medical Devices (the 'Opinions'), were recently issued by China's State Council, and set out a series of measures aimed at overhauling the regulatory approval regime. The Opinions set out a new classification system for medicinal products. 'New drugs' are defined as those not marketed anywhere in the world, in contrast to the current definition of drugs not marketed in mainland China, and are further classified into 'innovative new drugs' and 'improved forms of new drugs'.
A key focus of the Opinions is to accelerate the approval process for innovative drugs. China's regulatory body, the China Food and Drug Administration (CFDA), has suffered a backlog of applications over recent years which has delayed the launch of some drugs onto the Chinese market. In particular, the current regulatory review process can often lead to long delays for the approval of foreign products, even when their safety and efficacy has been well established in other international markets. The CFDA is urged to deal with all unprocessed drug applications by the end of 2016 and to process applications according to statutory review and approval timelines by the start of 2018. Certain innovative drugs will be subject to a new fast-track approval process by the CFDA, the exact details of which have yet to be announced in detail. The Opinions state that in order to benefit from an accelerated procedure, companies must agree to not charge prices that are higher than those in the originating or comparable market. The following categories of products may be eligible for fast-track approval:
drugs to treat HIV, malaria, malignant tumours, severe infectious diseases and rare diseases;
- drugs to respond to urgent clinical demand;
- innovative drugs with advanced formulation techniques, and
- innovative and paediatric drugs whose manufacturing has been transferred to China
Applications for innovative medical devices with patented core technologies and significant clinical value will also be reviewed using a fast-track procedure. Furthermore, domestic technical standards concerning medical devices will be adapted to international standards.
The Opinions also call for changes to the regulations concerning clinical trials for innovative drugs. In particular, in the future companies will be permitted to conduct trials in China at the same time as trials are conducted in other countries and any clinical data obtained from international multicentre clinical trials involving a Chinese institution can be accepted as part of the application dossier.
Currently, only drug manufacturers can obtain regulatory approval. However, the Opinions also provide for the introduction of a market authorisation holder (MAH) regime on a trial basis, enabling R&D institutions, small biotech companies, and researchers etc. to apply for marketing authorisations in their own name. The marketing approval may then be transferred to a manufacturer with minimal on-site inspection and product testing in contrast to the current requirement for the manufacturer to submit an entirely new drug approval application.
While the stated objective of the Opinions will be widely welcomed by the pharmaceutical and medical device industry, many uncertainties remain over how the changes will be implemented and what the fast-track process will mean in practice. As the Opinions only set out the general principles of the reforms to be implemented, further detailed measures and guidance is expected to be announced shortly by the CFDA with relevant laws and regulations being amended in due course.