CFDA Proposes Groundbreaking Reforms: Abolishes Clinical Trial Institution Qualification Approval and Accepts Overseas Clinical Data

VCBeat (WeChat ID: vcbeat), May 12 — The China Food and Drug Administration (CFDA) released an article late yesterday evening to solicit public comments on innovations in the management of clinical trials for drugs and medical devices, and drafted the “Policy Measures on Encouraging Innovation in Drugs and Medical Devices and Reforming Clinical Trial Management” (Draft for Comments), which is now open for public consultation.

The draft for public comment indicates that the regulations drafted by the Food and Drug Administration (FDA) involve significant changes, including replacing the accreditation of clinical trial institutions with a filing-based management system and abolishing the accreditation requirement for such institutions. The measures support investigators and clinical trial institutions in conducting clinical trials, and allow overseas enterprises and research institutions to conduct Phase I drug clinical trials in China. Furthermore, clinical trial data obtained abroad will be accepted; if such data meet the relevant requirements for drug and medical device registration in China, they may be used to support registration applications in China following successful on-site inspections.

Industry insiders analyze that, following the reforms, China’s clinical trial management and drug and medical device review and approval policies have aligned with international standards. This alignment is expected to accelerate the market launch of drugs and devices, thereby meeting public clinical needs. The reforms will also have a profound impact on the industry, with beneficiaries including pharmaceutical exporters, clinical research organization (CRO) institutions, and innovative drug R&D companies.

In fact, the China Food and Drug Administration (CFDA) had previously introduced multiple policies to innovate drug review and approval processes, including the Marketing Authorization Holder (MAH) system and relaxed registration requirements for imported drugs. The issuance of these policies demonstrates the CFDA’s encouragement of pharmaceutical innovation, making China’s pharmaceutical industry more open and competitively vibrant.

Attachment

On Encouraging Innovation in Drugs and Medical Devices

Relevant Policies for Reforming Clinical Trial Management

(Draft for Comments)

Revocation of Qualification Accreditation for Clinical Trial Institutions.Medical institutions that meet the conditions for conducting clinical trials may accept commissions from applicants to carry out such trials after registering and filing with the designated website of the food and drug regulatory authority. Social capital is encouraged to invest in establishing clinical trial institutions to provide professional clinical trial services. The principal investigator of a clinical trial must hold a senior professional title and have participated in more than three clinical trials. Applicants for clinical trials may engage third-party organizations to assess and certify whether the clinical trial institutions meet the required conditions. Following the implementation of a filing-based management system for clinical trial institutions, the food and drug regulatory authority shall strengthen on-site inspections of clinical trial projects and make the inspection results publicly available. Data from clinical trial projects that fail to pass the inspection will not be accepted by the food and drug regulatory authority.Regulations on the Management of Clinical Trial Institutions shall be formulated by the food and drug regulatory authorities in conjunction with the health and family planning authorities.

Support medical institutions, medical research institutions, and higher education institutions in medicine and pharmacy to participate in clinical trials, and incorporate the conditions and capabilities for conducting clinical trials as key indicators in the accreditation of medical institutions and the designation of key clinical disciplines. Encourage tertiary A-grade medical institutions and affiliated hospitals of provincial-level or above undergraduate medical colleges and universities to undertake clinical trial work. Establish a separate evaluation and assessment system for medical institutions conducting drug clinical trials; beds used exclusively for clinical trials shall not be counted toward the total bed count of the medical institution, and performance metrics such as bed efficiency, turnover rate, and utilization rate shall not be applied. Encourage medical institutions to establish dedicated clinical trial departments and staff them with professionalized clinical trial personnel. Encourage clinicians to participate in technological innovation activities related to pharmaceuticals and medical devices.Allow overseas enterprises and research institutions to conduct Phase I clinical drug trials in China.Medical personnel involved in conducting clinical trials shall be treated equally with clinicians in terms of job promotion and professional title advancement. In conjunction with improving the performance-based salary distribution and incentive mechanisms within institutions, the income levels of clinical trial investigators shall be guaranteed.

Clinical trials must adhere to ethical standards, ensuring that participants are provided with sufficient trial information prior to voluntary enrollment, understand and sign the Informed Consent Form, and have their safety, health, and rights protected. Medical institutions conducting clinical trials shall establish an Ethics Committee responsible for reviewing clinical trial protocols and making decisions on approval, requesting modifications, or disapproval; conducting periodic reviews and real-time monitoring of clinical trials while accepting inspections by regulatory authorities; and reviewing and supervising the qualifications of investigators at the institution.Each region may establish regional ethics committees as needed., responsible for reviewing and overseeing clinical trial projects undertaken by medical institutions and monitoring the qualifications of investigators; responsible for adjudicating appeals filed by investigators and applicants; and responsible for providing work guidance to ethics committees within medical institutions in the region. Health and family planning departments, traditional Chinese medicine administration departments, and food and drug regulatory authorities shall strengthen administrative guidance and professional supervision over the work of ethics committees.

Before submitting a clinical trial application to the review agency, the applicant shall first submit the clinical trial protocol to the ethics committee for review and approval.For multi-center clinical trials conducted within China, upon ethical review by the lead site, the ethics committees of other participating sites may accept the review conclusions of the lead site without conducting duplicate reviews.National Clinical Research Centers for Medicine and clinical trial institutions supported by the National Science and Technology Major Project and the National Key R&D Program shall integrate resources to establish a unified ethical review platform and progressively promote mutual recognition of ethical reviews.

Establish and improve the communication mechanism between applicants and regulatory review agencies. Prior to conducting Phase I and Phase III clinical trials of drugs, formal applications shall be submitted and accepted only after meetings between the applicants and the regulatory review agencies. Prior to conducting clinical trials of medical devices requiring approval, formal applications shall be submitted and accepted only after meetings between the applicants and the regulatory review agencies.If the review agency fails to issue a negative or questioning review opinion within 60 working days from the date of acceptance, it shall be deemed as approved, and the applicant may conduct clinical trials in accordance with the submitted protocol.During the clinical trial period, if there are changes to the clinical trial protocol, major pharmaceutical changes, or non-clinical study safety issues, the applicant shall promptly submit the details of such changes to the review agency. If safety concerns and other risks are identified, the applicant shall promptly amend the clinical trial protocol, suspend, or terminate the clinical trial. The review agency shall strengthen the review and supervision of the entire clinical trial process, organize on-site inspections of ongoing clinical trials, and may conduct for-cause inspections of clinical trial data during the review process.

Clinical trial data obtained by the applicant overseas, if compliant with the relevant requirements for drug and medical device registration in China, may be used to support registration applications in China following an on-site inspection.For international multi-center drug clinical trials conducted in China by overseas enterprises, if the trials comply with the relevant requirements for drug registration in China, a marketing authorization application may be submitted directly upon completion of the international multi-center clinical trials. For drugs and medical devices applying for initial marketing authorization in China, applicants shall provide clinical trial data demonstrating the absence of ethnic differences. Bioequivalence study data from generic drugs approved for marketing by the European Medicines Agency (EMA), the United States, and Japan may be used for generic drug registration applications in China, provided they meet the relevant requirements for drug registration in China and pass on-site inspections. For medical devices approved for marketing overseas, except for Class III medical devices requiring approval for clinical trials, the clinical trial data submitted at the time of overseas marketing approval may be used as clinical trial documentation for medical device registration applications in China.

For drugs and medical devices under clinical trials intended to treat serious, life-threatening diseases with no effective treatment options available, if preliminary observations from the clinical trials suggest potential benefits and ethical requirements are met, they may be used for other patients after obtaining informed consent. The safety data obtained can be used to support review and approval processes.Expanded-use investigational drug: restricted to institutions conducting Phase II and III clinical trials., the number of users shall not exceed the number of subjects specified in the clinical trial protocol.