The China Food and Drug Administration (“CFDA”) issued the Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Circular No. 53, 2017) (the “Draft”) on 11 May 2017. The Draft aims to establish a more efficient administration regime for clinic trials and ensure accessibility to new drugs for Chinese patients.
The key elements of the Draft are summarised below:
- A new recording regime will replace the existing approval regime for clinical trial institutions Currently, clinical trial institutions must receive approval from the relevant authorities before conducting clinic trials. Under the new regime, if a medical institution already has qualified clinical trial conditions, the institution does not require approval and instead can record the relevant conditions with the designated CFDA website, and then carry out clinical trials with the instructions from drug registration applicants. The CFDA will improve onsite investigation of clinical trials. If the investigation results in the decision that the clinical trial project is unqualified, relevant clinical data obtained in the trial will not be accepted by the authority. The Draft also encourages private investors to set up clinical trial institutions.
- Researchers and clinical trial institutions are encouraged to conduct clinical trials Medical institutions, medical research institutions and medical universities are encouraged to participate in clinical trial activities. The Draft encourages medical institutions to establish full-time clinical trial departments that are equipped with professional clinical trial personnel. Clinicians are also encouraged to participate in technological innovation activities for both drugs and medical devices. Foreign enterprises and scientific research institutions are encouraged to conduct ‘Phase I’ clinical trials for drugs in China.
- Clarifying the scope of authority of regional ethics committees The Draft states that each region should establish a regional ethics committee to review and supervise clinical trial projects undertaken by medical institutions as well as review the qualifications of the researchers involved in the clinical trials. Regional ethics committees would also be responsible for handling the appeal process in relation to researchers and clinical trial applicants, as well as providing guidance to ethics committees of medical institutions within the applicable region.
- Enhancing the efficiency of the review of ethical issues Before submitting an application to the evaluation authority for a clinical trial, the applicant should firstly submit the clinical trial proposal to the ethics committee for approval. For multi-regional clinical trials (the “MRCT”) conducted in China, if the ethics committee in the leading institution has reviewed the proposal, the ethics committees of subordinate institutions can accept the result of the review by the leading institution and are not required to conduct an additional review.
- Optimising the examination procedure for clinic trials Following a meeting between the applicant and the evaluation authority, the application for the clinical trial must have been filed with the evaluation authority and the evaluation authority must have accepted the application before the applicant can begin conducting ‘Phase I’ and ‘Phase III’ clinical trials for drugs. There are similar requirements in relation to the clinical trials of medical devices that require approval from the evaluation authority. If, within 60 working days from the date of accepting the application, the evaluation authority has not reached a negative conclusion, or has not requested further clarification, the application will be deemed to have been approved and the applicant may conduct the clinical trials in accordance with the submitted proposal. During the clinical trials, if there is any deviation from the proposal for the clinical trial, any significant pharmacy issue or any non-clinical research safety issues occur, the applicant should promptly submit the changes to the evaluation authority.
- Accepting clinical trial data collected overseas As long as clinical trial data collected overseas complies with the relevant requirements of Chinese drug and medical device registration, such data can be used for drug or medical device registration in China after the onsite investigation. Where an international drug MRCT has been conducted by a foreign enterprise in China in compliance with the relevant requirements of Chinese drug registration, the foreign enterprise can directly file the drug market registration application after the clinical trials. For drugs or medical devices that register in China for the first time, the applicant should also provide clinical trial data to prove there is no racial difference. If the bioequivalence trial data of overseas marketed generic drugs (i.e. generic drugs marketed in the EU, US and Japan) complies with the relevant requirements of Chinese drug registration, such data can be used for generic drug registration in China after the onsite inspection. In relation to medical devices marketed abroad, except for the Class III medical devices that require clinical trial approval, the clinical trial data which was submitted for overseas approval can be used for the medical device registration in China.
- Supporting extended clinic trails In relation to drugs and medical devices that are used for the treatment of life-threatening diseases where there are no other effective treatment methods, and which are subject to clinical trials, if such drugs and medical devices are found to have a potential positive effect during the preliminary observations of the clinical trials, and if the ethical requirements have been satisfied, such drugs and medical devices can be used for other patients with informed consent and the corresponding safety data can be used for registration evaluation. Such extended access to drugs under clinic trial can only be available in clinical trial institutions that are conducting Phase II and Phase III clinical trials, and the number of patients using such drugs should not exceed the number of subjects defined in the clinical trial proposal.
Once the clinical trial data gained overseas and the data of MRCTs can be accepted by the Chinese authorities, multinational pharmaceutical companies will benefit in both time and cost efficiency. The authority's stance on ethical issues requires the attention of affected companies in order to ensure such companies are prepared for the introduction of these additional requirements.