New GCP of Medical Devices
China Insight - Lifesciences
On 23 March 2016, the China Food and Drugs Administration (“CFDA”) and National Health and Family Planning Commission (“NHFPC”) jointly issued the new Good Clinical Practice of Medical Devices (“New GCP”). This New GCP will replace the Provisions on Clinical Trials of Medical Devices effective from 1 April 2004. The New GCP will take effect from 1 June 2016 but it will not apply to in vitro diagnostic reagents.
According to the Administrative Measures of Registration of Medical Devices, the Class II and Class III medical devices, except those exempted from clinical tests as publicly listed by the CFDA, are subject to clinical test and their clinical tests need to be filed with the local FDA. In addition, the clinical tests of some Class III medical which have high risks further need to be approved by the CFDA. Therefore, the New GCP will have larger impact on the clinical tests of Class II and Class III medical devices.
The New GCP has 11 chapters, including (1) general principles, (2) preparation for clinical trial, (3) protection of rights of subjects, (4) program of clinical trial, (5) duties of ethics committee, (6) duties of applicant, (7) duties of clinical trial entities and researchers, (8) records and reports, (9) administration of medical devices for clinical trial, (10) administration of basic documents and (11) miscellaneous. It has enormously added the rules of clinical trial to be complied with by applicant, ethics committee, clinical trial entity and researcher and increased the protection for subjects. Duties and obligations of relevant parties in the clinical tests of medical devices will be streamlined and the applicants for clinical tests, i.e. manufacturers of medical devices, will be much more affected by this New GCP. The main contents of the New GCP are as follows:
- A chapter regarding preparation for clinical trial is added in the New GCP. It adds some more conditions for carrying out clinical trials, including providing the test report made by a qualified testing entity within 1 year, having filed the clinical trial with the local provincial FDA, having obtained the approval for clinical trial of Class III medical device.
- In the chapter regarding the protection of rights of subjects, in addition to keep the list of information regarding the clinical trial to be disclosed to subjects in the old Provisions on Clinical Trials of Medical Devices, the New GCP adds the obligations of an applicant for clinical trial to provide the ethics committee with a series of documents for ethics control, to report to the ethics committee the serious adverse events, status of clinical, and deviations in the clinical trial, etc., and not to mislead the subjects by exaggerating the indemnification for receiving the clinical trials.
- A chapter regarding the program of clinical trial is added in the New GCP. It requires that an applicant for clinical trial is obliged to prepare the program of clinical trial and identifies the scope of such program. Otherwise, there is no guideline for carrying out clinical trials.
- The chapter regarding the ethics committee’s duties is also a newly added chapter in the New GCP. This chapter specifies the composition of the ethics committee, the qualifications of its members and rules of procedure. The ethics committee is granted the rights to suspend and terminate clinical trials.
- It is specified in the New GCP that the applicant for clinical trial shall be responsible for the truth and reliability of clinical trial data. It is a difficult obligation to be performed by the applicant in the current practice. At present, the number of existing medical institutions which can carry out clinical trials is far below the demand for clinical trials. It is quite often that an applicant cannot control the status of a clinical trial by a medical institute. In order to implement such responsibility, the New GCP requires the applicant to establish monitors to carry out monitoring over the entire process of clinical trial and sets out the detailed duties of such monitors.
- The New GCP also extends the term for keeping the records for clinical trials. The medical institute shall keep the materials for clinical trial for 10 years after ending of a clinical trial and the applicant shall keep such materials until no longer use of such medical device, which is deemed to be an infinite period.
In respect of clinical trial of medical devices, the New GCP is one of regulations to be enacted according to the Supervision and Administration Regulation of Medical Devices. The other one is the Administrative Measures on Verification of Qualification of Entities for Clinical Trial of Medical Devices. The draft of such regulation was issued for public comments in July 2015 and it is envisaged that this draft may be passed and enacted