The European Medicines Agency (EMA) is considering revising its guidance on clinical trial reference safety information (RSI) after drug developers complained the current situation is delaying the start of studies. In response to the grievances, EMA has encouraged the industry to discuss the concerns with the Heads of Medicines Agencies’ (HMA) Clinical Trial Facilitation Group (CTFG).
Drug developers brought up the topic at meeting with EMA about pharmacovigilance last month, a summary of which has just been released by the regulator. The complaint was prompted by an uptick in the number of questions and objections relating to the RSI parts of trial applications and updates to investigator brochures. RSI is a list of the medical reactions a sponsor expects to see when a drug is given in a clinical trial. Sponsors have been required to submit this information for some time, but as they see it, the demand, or, more accurately regulators’ responses to it, has become a burden.
As the industry sees it, the problems stem from the lack of aligned, detailed guidelines across the EU. Drug developers want to see such a document brought into force. While regulators are working on the document, the industry is asking for a transition period to be implemented to prevent the existing guidance from causing any more delays to the initiation of clinical trials.
Whether regulators meet the industry demands remains to be seen. EMA, which wrote up the exchange in the minutes to the pharmacovigilance meeting, said the next step is for the industry to raise its concerns with CTFG, a group HMA set up to coordinate the implementation of the clinical trial directive. Now, CTFG also serves as a place industry can discuss the need for principles that apply across the European regulatory network. EMA is advising industry to use this existing forum to discuss RSI, specifically the need to update guidance.
The topic was one of many discussed at the EMA-industry pharmacovigilance meeting. Among the notable issues raised by the industry was the adoption of safety features to comply with the Falsified Medicines Directive. Again, harmonization is a concern. EMA is seeking to allay the worries by talking to the European Commission. The talks will focus on the need to ensure the safety feature rules are applied consistently across the EU.
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