Review and Approval Process of the Market Registration of Drug and Medical Device to be accelerated

The China Food and Drug Administration (the “CFDA”) issued the Relevant Policies on Encouraging Innovation of Drugs and Medical Devices and Accelerating the Review and Approval Process of the Market Registration of New Drugs and Medical Devices (Circular No.52, 2017) (the “Draft”) on 11 May 2017. The Draft reinforces a ‘fast track’ for certain kinds of drugs and medical devices, improves the examination process for registration and suggests a fast track for drugs that have a compulsory licence.

The key elements of the Draft are summarised below:

1. Accelerate the review and approval process for the registration of drugs and medical devices that are urgently required in clinical use For drugs and medical devices that are used for the treatment of life-threatening diseases where there are no other effective treatment methods or that have significant value for unmet medical needs, if the drugs or medical devices’ curative effects can be indicated in the early and interim phases of the clinical trial and the clinical value can also be predicted, such drugs and medical devices may be approved for market with conditions. The applicants of such drugs and medical devices should develop a risk control plan, carry out confirmatory clinical trials as required and complete the research specified in the approval documents. Innovative drugs and medical devices which have been listed as either a ‘National Science and Technology Major Project’ or ‘National Key Research and Development Project’ can also benefit from the fast tracked review and approval process.
2. Support research and development for drugs and medical devices for the treatment of rare disease The National Health and Family Planning Commission (the “NHFPC”) will publish a Catalogue of Rare Diseases and establish a registration system for patients with rare diseases. For drugs and medical devices for rare disease treatment, applications for simplified clinical trials can be filed and such drugs and medical devices may even be exempt from clinical trials. Drugs and medical devices for rare disease treatment that have been marketed abroad can be approved for market in China with conditions and relevant research should be completed within the period defined in the conditions.
3. Stricter approval process of injections If oral preparation is sufficient for clinic treatment, injection preparation should not be approved. Similarly, if intramuscular preparation can meet the needs of clinic treatment, intravenous preparation should not be approved. Applications for interchanges within types of large volume injections, small volume injections and sterile booster injection without obvious clinical advantages should not be approved.
4. Adjust the management system of medicinal raw materials and packaging materials The Administrative Measures on Recording the Medical Raw Materials and Packaging Materials is to be drafted. An information platform for recording will also be established, which the drug evaluation authority can use to review and approve materials together with the drug register application.
5. Improve the evaluation system for drugs and medical devices A more efficient communication regime between the evaluator, the applicants and experts will be established. Meetings of the evaluator and the applicant must be held to enable thorough communication on three critical points: (i) before filing the application for a Phase I clinical trial, (ii) after the completion of the Phase II clinical trial but before the Phase III clinical trial, and (iii) after the completion of the Phase III clinical triall but before filing the market application. Any major technical disagreement must be publicly debated by the expert advisory committee. Such experts should listen to the opinions of the applicant as well as the evaluator before giving any opinion which will then be used as a reference for the evaluation result. All of the evaluation conclusions, except for the enterprise’s trade secrets involving the production process and parameters, should be accessible by the public.
6. Support the clinical application of new drugs Medical institutions are encouraged to purchase and use new drugs that are of great curative effect and that are a reasonable price. The relevant authorities should also conduct research on, and improve the dynamically adjusted mechanism of, the Drug Reimbursement List and establish a negotiation regime on the payment standards of the reimbursed drugs. Innovative drugs are encouraged to be included in the reimbursed list.
7. Support the heritage and innovation of traditional Chinese medicine A registration regime and technology evaluation regime that is suitable for the nature of Chinese traditional medicines is to be established.
8. Establish a priority review and approval system based on patent compulsory licensing If the intellectual property department decides to impose a compulsory licence for a patent of a drug, the drug evaluation authority should give priority to the review and approval of the registration application of such drug.

The Draft emphasises the CFDA's determination in improving and accelerating the long review and approval process for the registration of drugs and medical devices. Once the draft becomes effective, new drugs are expected to be approved in a shorter period, in particular if drugs are urgently needed in clinics or for the treatment of rare diseases.