In late 2014, China announced new medical device regulations. One of the most important new regulations stated that all Class II and Class III devices will require local clinical studies in China for approval if they are not on the exempt list. This requirement means that it is imperative for device manufacturers to be aware of the changing clinical trial regulatory environment for medical devices in China.
In March 2016, the CFDA (China Food and Drug and Administration) and National Health and Family Planning Commission (NHFPC) jointly issued new Good Clinical Practice (GCP) guidelines, which were implemented in June 2016. These guidelines are detailed in CFDA Decree #25. The new GCP medical device requirements for clinical trials in China include 96 articles and 11 chapters, which is a dramatic increase from the 29 articles and 6 chapters included in the 2004 GCP clinical trial regulations. The new GCP outline details the timing of trials, the rights of trial participants, trial protocol, sponsor responsibilities, pre-trial preparations, ethics committee responsibilities, sponsor responsibilities, management of equipment, and management of documents, among others. In other words, the requirements that device manufacturers must abide by when conducting clinical trials in China have grown significantly in both depth and breadth. Unfortunately, the CFDA has yet to release an English language translation of the new GCP specifications.
Important Updates to Chinese GCP Requirements
Ethics Committee. Due to the large number of fraudulent clinical trials in China recently (in fact, 85% have been withdrawn from the CFDA over the last year) the provisions concerning ethics committees have been dramatically expanded.
The previous 2004 specifications simply state in one section of Article 11 that the experiment protocol and any changes to that protocol should be submitted to an ethics committee for ratification. It also had several references to certain situations in which the ethics committee would take action. The new 2016 specifications, on the other hand, has an entire chapter that spans from Article 30 to Article 38, dedicated to the composition and responsibilities of the ethics committee. According to Article 30, there must be at least five members of the committee (with both genders represented) of both medical professionals and non-medical professionals. Articles 31–37 have a variety of other guidelines concerning the duties of the ethics committee and its relationship to the organizations in charge of the trial.
Article 33 has nine clauses listing areas where members of the ethics committee should closely scrutinize the trials. These include the qualifications of researchers, the risk of participants being harmed, whether the clinical trials follow ethical principles, and whether the participants have been selected appropriately and given accurate information about the clinical trials in advance.
Pre-Trial Preparations. The requirements for pre-trial preparations have also been expanded in the new GCP regulations. While the previous GCP standards mention several issues, the new GCP specifications have an entire chapter with seven articles specifically devoted to pre-trial preparations. According to Article 27, devices that are brand new (not yet approved in either China or elsewhere in the world) must present supportive evidence from a small-scale feasibility study. Prior to completing the protocol for subsequent trials, a statistical analysis of the small-scale trial should be used to determine the sample size of those trials. The previous requirement in Article 6 of the old GCP was simply for all new implantable devices or any device that proved its safety by means of animal testing to submit an animal testing report.
Clinical Trial Participants. Another area of significant additions is the rights of the trial participants. In the previous GCP regulations, Articles 7–9 covered the rights of trial participants. The content was mostly confined to laying out the general terms of informed consent. The new guidelines, however, cover the rights of trial participants in a section that goes from Article 13 to Article 25, and also broaden the definition of informed consent. Article 17 lays out a list of ten specific types of documents that must be provided to the ethics committee before a clinical trial can begin, including the researcher’s manual, proof of the experience of the researchers, and the forms used to recruit participants, among others. Article 20 says that every effort should be made to avoid selecting non-adults, pregnant women, the elderly, or those who are in critical condition as clinical trial subjects.
Going forward, as the standard of living in China rises and Chinese citizens demand better healthcare, medtech safety and quality regulations are rising steadily as well. These updated medical device GCP specifications represent a major step by Chinese regulators to raise the standards of clinical trials that are conducted in China. Foreign medical device manufacturers looking to register and sell their products in the Chinese market must be confident that the organizations they contract to perform clinical device trials in China are aware of and ready to comply with these new requirements. If they do not, the consequences will be severe.