CFDA Reopens Public Consultation on Handling Measures for Drug Clinical Trial Data Verification with 10 Days Remaining

VCBeat (WeChat ID: vcbeat), April 10 – The China Food and Drug Administration is actively incorporating industry feedback to improve the regulatory framework for clinical drug trials, introducing remedial measures for cases of clinical data fabrication that are not subjectively intentional or are influenced by objective factors.

The General Office of the China Food and Drug Administration (CFDA) today released the “Announcement on Handling Issues Related to the Verification of Clinical Trial Data for Drugs (Revised Draft),” once again soliciting public comments on the verification of clinical trial data for drugs. The deadline for submitting feedback is the 21st of this month.

The article stated that the China Food and Drug Administration (CFDA) had previously drafted the “Announcement on Handling Issues Related to the Verification of Clinical Trial Data for Drugs (Draft for Comment)” (hereinafter referred to as the “Handling Opinions”) and solicited public comments for the first time from August 19 to September 18 last year. During this period, a total of 280 feedback items were received from pharmaceutical companies, medical institutions, contract research organizations (CROs), industry associations, and other entities and individuals.

The China Food and Drug Administration (CFDA) revised the "Handling Opinions" in light of the feedback received, establishing classified determinations for cases of falsification in clinical trial data.Distinguish non-subjective and other objective factors, and provide remedial measures. The specific circumstances under which remedial measures are available are as follows:

I. Data fabrication does not include the underreporting of serious adverse events potentially related to investigational medicinal products or the underreporting of concomitant medications prohibited by the study protocol.

II. For applicants penalized for fabricating data in drug clinical trials, special applications may be submitted for the drug products involved during the penalty period if they are indeed urgently needed for clinical use. The China Food and Drug Administration shall organize expert deliberations to decide whether to accept such applications.

III. For drug clinical trial institutions involved in data fabrication, the requirement for rectification within a specified time period shall be adjusted from the entire institution to the specific specialties involved.

IV. For principal investigators involved in data fabrication, all registration applications for their participation in studies that have been accepted shall be adjusted from disapproval to suspension of review and approval.

V.For products involved in data falsification, clarify the procedures for handling responsible personnel and adjust the content disclosed to the public and included in the blacklist.

VI. Add relevant content regarding the handling of cases and administrative reconsideration by the parties involved, specifying the concrete procedures and channels.

Nevertheless, the China Food and Drug Administration (CFDA) remains resolute in its crackdown on fabricated clinical trial data in drug registration applications, mandating that such data be authentic, complete, and compliant with regulatory standards. In line with this principle, the CFDA also refuted, in its article, proposals such as adjusting the perceived proportion of data fabrication, exempting applicants from penalties, and implementing a blacklist system.

Opinions mounted on the muzzle are divided into three categories, including:

I. It is recommended that handling be based on the proportion of fabricated data discovered, with no administrative penalties imposed when the proportion is low. Laws and regulations stipulate that the nature of the illegal act itself determines its classification, while the specific quantity constitutes a matter of circumstance. After discovering data fabrication during drug clinical trial data verification, the China Food and Drug Administration (CFDA) terminated the verification process. Given that the verification of all drug clinical trial data was not completed, the authenticity of the remaining data cannot be guaranteed. Therefore, there is insufficient legal basis for handling cases based solely on the proportion of fabricated data discovered. This comment was not adopted.

II. It is recommended that penalties be imposed only on clinical trial institutions and investigators involved in data fabrication, and not on the applicants. According to laws and regulations, the applicant submits the drug registration application and bears corresponding legal liabilities. As the sponsor and beneficiary of the clinical trials, the applicant must ensure the authenticity, integrity, and compliance of the clinical trial data included in the registration application and is therefore the primary subject of legal liability. This comment was not adopted.

III. It is recommended that specific information about individual monitors not be included in the blacklist. Establishing a blacklist system, specifying the individuals listed, strengthening accountability for specific monitoring personnel, and making the list public are effective measures to promote the applicant’s fulfillment of oversight responsibilities for drug clinical trial implementation. This suggestion was not adopted.

In fact, in recent years, the China Food and Drug Administration (CFDA) has actively implemented reforms in new drug application approvals and pharmaceutical reviews, achieving notable results as evidenced by initiatives such as mandating self-inspection of clinical data by pharmaceutical companies and establishing priority review pathways.

What remains deeply etched in the memories of industry insiders is the “July 22 Incident”—the announcement of self-inspection and verification of clinical trial data for drugs, hailed as the most stringent in history. This regulatory crackdown led to a sharp decline in drug registration applications and prompted relevant responsible parties to prioritize compliance with clinical trial data standards.

This is also regarded as a “supply-side reform” in drug regulation carried out by the China Food and Drug Administration (CFDA). Data on new drug approval applications show that, according to reports released by the Center for Drug Evaluation (CDE), the number of new drug registration applications, which previously stood at nearly 8,000 per year, was almost halved last year.