Grace Fu Palma, founder and CEO of Boston-based China Med Device (chinameddevice.com), a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers new updates on CFDA clinical trial reform in China by CFDA. China Med Device specializing in providing turn-key solution for medtech companies, brings you up to date information on CFDA. If you have any feedback, please e-mail to email@example.com.
On May 11, 2017, the State Food and Drug Administration issued a notice (Opinion No. 53 of 2017) on the “Policy on Encouraging the Reform of Clinical Trials of Drugs and Devices Innovations” (draft). The “draft” is to further deepen the review and approval system reform, promote the pharmaceutical and medical device industries restructuring and technological innovation, improve industrial competitiveness, and to meet the public needs.
1. Accreditation approval to letter to file.
The clinical trial institution qualification approval has been changed from the original accreditation process by CFDA to a simple letter to file at the designated registration website. The reform intends to encourage social capital investment to set up clinical trial institutions and to provide clinical trial professional services. The main investigators should have a senior title and have participated in more than three clinical trials. Clinical trial Applicants may employ a third party to evaluate the accreditation of the clinical trial institution. The supervision and validation will be shifted on-site inspection by CFDA officials. The inspection results will be announced to the public. Failure to pass the examination of the clinical trial project, the relevant data will be rejected by CFDA.
2. Support researchers and clinical trial institutions to carry out clinical trials.
Encourage healthcare institutions, teaching hospitals and research organizations to undertake clinical trials. Clinical trial beds does not require bed efficiency, turnover rate, utilization and other evaluation indicators. Encourage medical institutions to set up full-time clinical trial departments, equipped with professional clinical trial personnel. Encourage clinicians to participate in technological innovation activities in pharmaceutical and medical equipment. To allow foreign enterprises and scientific research institutions in China to carry out drug phase Ⅰ clinical trials. Clinical trial Medical staff shall enjoy the same job promotion, title, treatment and financial compensation as the other practicing clinicians.
3. Perfecting Ethic Committee Mechanisms: it stipulated protection mechanisms for patients.
EC is responsible for clinical trial plan approval, modification or rejection. It needs to periodically check and monitor real time and accept upper supervision bureaus inspection, its own organization professional qualification.
4. Improve the efficient of EC professionals.
Clinical trial application organization should submit its trial plan for approval. If there are multiple trial sites, once the master trial site plan has been approved, the other sites do not need to go through approval process. Their trial plans can be accepted automatically. This is especially true when the trial is related to China important science or research projects. Encourages recognition of clinical trial plan by different ECs.
5. Optimizing Clinical Trial Evaluation and Approval.
Need to establish and perfect the dialogue and communication between the approver and applicant. For phase I and III drug trial, 60 days after the trial approval body acceptance of the trial, if there are no rejects or questions, it shall be interpreted as the trial has been approved to go on.
6. Acceptance of Overseas Clinical Trial Data.
Overseas multi-site clinical trial data if meeting CFDA regulatory requirements can be accepted. If it is 1st time application in China, ethnic conformity needs to be proven. For generic drugs, if meeting CFDA regulation, it can follow generic drugs approval process. For medical devices, unless it is class III on the clinical trial requirement list, the data can be accepted.
7. Expanded Clinical Trial.
Trials relating to treating fatal and no-cure diseases, after showing initial benefit, meeting EC requirements, and patient consent, the trial can be used on other patients and their data can be used for approval. They are limited to phase II and III trials.