THE NEW STANDARDS AND PROCEDURES FOR THE EXPEDITED REPORTS OF SAFETY DATA DURING CLINICAL TRIALS RELEASED BY CHINA

15 May THE NEW STANDARDS AND PROCEDURES FOR THE EXPEDITED REPORTS OF SAFETY DATA DURING CLINICAL TRIALS RELEASED BY CHINA

27th April 2018 the CDE has published the “Standards and Procedures for the Expedited Reports of Safety Data during Clinical Trials” (abbreviated as “the current standard and procedures”) on their website. According to this document, from 1st of May 2018 serious and unexpected adverse drug reactions reported during the clinical trials in China are subject to below regulations :”E2A: Management of clinical safety data: definition and criteria for rapid reporting”, “M1: MedDRA” And “E2B (R3): Management of clinical safety data: data elements for the transmission of individual safety reports”.  On the positive side, the greater impacts on the pharmaceutical company are following:

The sponsor is to take the responsibility of its main body, and to ensure that evaluation and management of all safety data of the drugs. The sponsor needs to do more about pharmacovigilance, such as establish a independent PV department or team in the company or/and have professional and experienced employees to meet the technical requirements from government. The new clinical trial project must perform SUSAR assessments and reports in accordance with the new requirements, as well as the E2B for report submission, which requires manual editing of the XML file. Therefore, a special pharmacovigilance data system is necessary for every pharmaceutical company. The system can help sponsors to edit and submit relevant reports more easily and efficiently.

The convergence of technical aspects with ICH standards will be the biggest challenge for pharmaceutical companies in China. The most direct result is that the cost of clinical research will increase substantially, and the failure rate of clinical research will also increase.
Therefore, a strong pharmacovigilance team and an informatization system must work together. NJYZ has an expert PV team with more than 20+ years experiences in China and aboard. We have an one-stop PV database system, which can satisfy the generation of E2B R2/R3 documents and provide an efficient and cost-saving pharmacovigilance services. We are also an overall solution provider for pharmacovigilance services, and we can support a variety of cooperation strategies for long-term partners.
We will continue to pay attention to this new information, and we’ll keep you posted on significant developments in the coming future!
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