What revolutionary changes the new draft for comment of CFDA on clinical trials will bring?

CFDA issued the Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment) at midnight of May 11 to solicit comments from the society.

Announcement of the CFDA on Seeking Public Comments on Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment) (2017 No. 53)

Issued on May 11, 2017

To further intensify the reform of the review and approval system, promote the structural adjustment of and technological innovations in the pharmaceutical product and medical device industry, enhance the industry competitiveness, and meet the clinical needs of the general public, China Food and Drug Administration has consulted with relevant departments of the State Council and drafted the Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment) and is now soliciting comments on this Draft from the society. Comments concerning revisions are suggested to be sent by e-mail to CFDA’s Department of Drug and Cosmetics Registration by May 25, 2017. The deadline for the submission of comments is June 10, 2017.

Any content in the Draft involving amendments to laws and regulations will be handled in accordance with the relevant procedures.

This announcement is hereby issued.

Annex: Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment)

There are mainly 7 pieces of information in this Draft. Next, I will interpret them piece by piece to explain in detail what revolutionary changes these policies will bring to the clinical trial field.

• Change clinical trial institution qualification recognition to filing management. The main content is: Cancel the qualification recognition of clinical trial institutions. After registration and filing on the websites designated by the food and drug regulator, all medical institutions with clinical trial conditions can accept applicants’ entrustment to conduct clinical trials. Social capital is encouraged to be invested in the establishment of clinical trial institutions to provide professional clinical trial services.

  Interpretation: In my opinion, the tension of the clinical trial resources can be relieved after implementation of the filing management.

  The qualification recognition method has been adopted for the clinical trial institutions in China all this time, with the recognition procedure generally divided into three steps, separately being: acceptance of qualification recognition, onsite inspection for qualification recognition, and review and announcement on qualification recognition, being quite tedious and troublesome.

  Procedure and flow of qualification recognition of clinical trial institutions are as follows:
  
  
   

• There have been only about 475 clinical drug trial institutions that obtain the qualification recognition of CFDA so far, and they are mainly 3A-grade hospitals.

  Article 2: Support investigators and clinical trial institutions in carrying out clinical trials. The main content is: Conditions and capabilities for clinical trials shall be incorporated as a key indicator for the level appraisal of medical institutions and the determination of key clinical disciplines; a separate evaluation and examination system shall be established for medical institutions conducting drug clinical trials. Hospital beds used only for clinical trials shall not be counted in the total number of hospital beds in such medical institutions, and the benefit, turnover rate and utilization rate of hospital beds, etc. shall not be specified as evaluation indicators. Medical personnel who conduct clinical trials shall be treated equally with clinicians in post promotion and professional title promotion, etc.; income level of the clinical trial investigators shall be guaranteed by combining with and improving the unit’s performance salary distribution and incentive mechanisms.

  Interpretation: In my opinion, there will be more investigators and clinical trial institutions participating in the clinical trials after the formal implementation of this article.

  ICH-GCP specifies that medical institutions, CROs and independent research institutions may be the subject implementing the clinical trials, however, the clinical trials take up medical resources, and the clinical trial costs increase the wage cost of medical personnel and the opportunity cost of hospitals, therefore, many hospitals and medical workers lack enthusiasm for clinical trials. Measures including incorporating clinical trials in various evaluation indicators and improving the salary distribution and incentive mechanisms will well arouse the enthusiasm of investigators and clinical trial institutions in participating in clinical trials.

  Article 3 and Article 4 are separately: Perfect the ethics committee mechanism and increase the efficiency of ethical review. Both of them are related to the ethical review of clinical trials. The key content includes: Each region may establish a regional ethics committee as needed. In the event of multicenter clinical trials in China, after the ethical review by the head institution, the ethics committees of member institutions may accept the review conclusions reached by the head institution to avoid repeated review. The state clinical research centers for medical science of China and clinical trial institutions that have obtained support regarding China’s National Science and Technology Major Projects and China’s National Key Research and Development Programs shall integrate their resources to establish a uniform ethical review platform and gradually advance the mutual recognition of ethical reviews.

  Interpretation: In my opinion, this article further regulates the flow of the multicenter clinical trials and forebodes the possibility of unification in ethical reviews in the future.

  The provisions of the Guidelines for Ethical Review Work of Drug Clinical Trials issued by CFDA in 2010 on the multicenter clinical trial ethical review are: A multicenter clinical trial may establish a work procedure for the coordination of conducting reviews. Before implementation of the research project, the ethics committee of the head institution is responsible for reviewing the scientific merits and ethical rationality of the trial protocol. Under the premise that all ethics committees of the participating institutions accept the review opinion of the ethics committee of the head institution, they are responsible for reviewing the feasibility of the trial to be conducted in their institutions. As this guideline fails to define the corresponding mechanism to guarantee the ethical review quality of the head institution and lacks the corresponding mechanism to divide the review responsibilities of the head institution and participating institutions, the ethical reviews in reality do not fully follow the regulation. The above policy specifically defines that the review will not be repeated after ethics committees of other member institutions accept the review conclusions reached by the head institution.

  Furthermore, most Chinese ethics committees have been established by the clinical trial institutions as required by GCP, and they have no unified normative system concerning file management and manning, etc., therefore, the ethical review information is chaotic. The above policy encourages each region to establish a regional ethics committee and integrate the ethical review platforms. The scheme will advance the feasibility of mutual recognition of ethical reviews of clinical trials after implementation.

  Article 5: Optimize the review procedures for clinical trials. The key content is: A mechanism for communication and exchange between applicants and the review institution shall be established and perfected. The review institution will be deemed as agreeing to the trial if it does not negate or question the trial within 60 working days from the acceptance date, and the applicant can conduct the clinical trial according to the protocol submitted.

  Interpretation: In my opinion, this article forebodes the feasibility of implementing project administrator system and can further accelerate the reviews.

  CFDA Director Bi Jingquan mentioned in the 1^st China Drug Regulation Scientific Congress held in Beijing in September last year that the project administrator system would be implemented for the pharmaceutical product review and approval, to have reviewers communicate with applicants in important nodes of clinical trials to increase the review efficiency. Let us wait and see whether the project administrator system could be successfully implemented.

  Article 6: Accept overseas clinical trial data. The key content is: If the clinical trial data obtained by the applicant overseas meet relevant requirements for Chinese pharmaceutical product and medical device registration, such data can be used for registration application in China after the site inspection is conducted. With respect to international multicenter drug clinical trials conducted in China by foreign enterprises, if the trial conforms to relevant requirements for registration of pharmaceutical products in China, a marketing application may be filed directly after the completion of the international multicenter clinical trial. With respect to a first-time application for marketing of a pharmaceutical product or medical device in China, the applicant shall provide clinical trial data showing that no ethnic differences exist. The applicant’s bioequivalence trial data for a generic drug that has been approved the marketing by European Medicines Agency, the U.S., and Japan may be used for the registration application of the generic drug in China, if such data conform to relevant requirements for pharmaceutical product registration in China and after the site inspection is conducted. For the medical devices of applicants approved to be marketed overseas (except the medical devices of Class III required clinical trial approval), the clinical trial data submitted at the time of obtaining the overseas marketing approval can serve as the clinical trial materials and be used for medical device registration application in China.

  Interpretation: In my opinion, this article is most valuable. With the acceptance of the overseas clinical trial data, applicants can reduce some clinical trials, to accelerate the review and approval. It will benefit two circumstances in the short term: One is for Chinese enterprises which already have generic drugs approved to be marketed by the European Medicines Agency, the U.S., and Japan, or manufacturers of import generic drugs that have been localized in China: hopefully, they will be exempted clinical trials, approved to market their products, and approved the consistency evaluation qualification; two is the synchronous marketing of foreign new drugs in China.

  Article 7: Support expanded clinical trials. With respect to drugs and medical devices currently under clinical trials and used for treating serious life-threatening diseases that have no effective treatment, if preliminary observation via clinical trials indicates that such drugs and medical devices may be beneficial and conform to ethics requirements, then upon informed consent, such drugs and medical devices may be used on other patients, and their safety data may be used to support the review and approval.

  Interpretation: In my opinion, this measure further accelerates the marketing of medical devices used for treating serious life-threatening diseases that have no effective treatment.

Author: Caicai