MHRA and Health Canada release new clinical safety reporting guidance

Under the new guidance, Development Safety Update Reports must include a description of the process used to review the worldwide safety data of the investigational drug.

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have jointly published new guidance to improve clinical trial safety via enhancing the quality of the periodic Development Safety Update Reports (DSURs). The guidance applies to both marketed and non-marketed medicines that are undergoing clinical trials.

Each year, DSURs are produced to review the safety of medicinal products used in clinical trials. However, detailed safety assessments regarding safety concerns conducted by trial sponsors are not always included in the DSUR. Thus, it can be difficult for regulators to assess whether all safety concerns have been thoroughly investigated and if appropriate measures have been taken to mitigate the risks associated with the use of the investigational medicinal products during a trial.

The new guidance is designed to improve transparency and ask sponsors to explain in the region-specific information section how they assessed the data included in the DSUR. It builds on relevant existing international standards, including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance E2F, the Council for International Organizations of Medical Sciences (CIOMS) Working Group VII as well as each country’s relevant clinical trial legislation.

The MHRA and Health Canada added that by increasing DSUR transparency requirements globally, patients would be safeguarded and regulators would be better able to monitor how safely medicines are being investigated.

The guidance document states that while it is understood that the DSUR should not be used to communicate new safety issues, it should describe the actions taken to address safety concerns identified during the reporting period. “There is a need for sponsors to be more transparent about how they have reviewed, evaluated and interpreted the data included in a DSUR. The increased quality of the information included in the DSUR will facilitate the regulatory review process, will reduce additional requests of information from the regulatory authorities and ultimately demonstrate that the investigational drug is used in a safe manner.”

Under the new guidance, the region-specific information section of the DSUR should include a summary description of the process used by the sponsor to review the worldwide safety data of the investigational drug; how each signal was evaluated; and how a decision was made to close or keep open the signal. This signal evaluation description can be provided in the form of a table or text description.