EU Clinical Trials Delayed By Poor Reference Safety Information
Executive Summary
EU regulators are increasingly raising objections over the reference safety information that companies include in their clinical trial applications and updated investigator's brochures.
A number of clinical trials sponsored by the innovative pharmaceutical industry have experienced delay in the EU because of companies failing to satisfy the expectations regulators have with regard to the reference safety information (RSI) submitted in clinical trial applications and as updates to investigator brochures.
Regulators are increasingly focusing on the RSI in submissions and are raising a number of questions and objections on this front, according to the European Federation of Pharmaceutical Industries and Associations.
Some 87.5% of the 16 EFPIA members that responded to a recent survey by the trade group said they were aware of problems in this area and that almost all their IB updates and clinical trial applications had been impacted, EFPIA told the Pink Sheet.
EU-level guidance is needed on regulatory expectations for RIS, according to EFPIA. RSI refers to the list of medical events that defines which reactions are expected to occur for the investigational medicinal product being administered to trial subjects and, as such, do not require expedited reporting to the competent authority. Investigator brochures also contain RSI.
The lack of up-to-date EU-level guidance on RSI means that there is not enough consistency in how regulators across Europe deal with RSI, the trade group explained, adding that companies have adapted “as best they can but not in a coordinated manner."
EFPIA is calling for the Heads of Medicines Agencies' Clinical Trials Facilitation Group to draft a single EU-aligned guidance on RSI. The association believes that additional clarification of the regulatory expectations on this front will avoid the risk of divergent interpretations from the member states.
EFPIA is consolidating a position paper on the matter that it will submit to the CTFG for discussion.
In the meantime, it said that member states should be pragmatic in their assessment of clinical trial RSI and ensure that their approach complies with current guidance.
EFPIA first highlighted the problems that companies face due to the increased regulatory focus on RSI in July at the European Medicines Agency's eighth industry meeting on the operation of the EU pharmacovigilance legislation. It clarified that the focus on RSI relates to the assessment of applications for clinical trials and updates to investigator brochures and not to good pharmacovigilance practice inspections.
The industry group believes that the increased focus on RSI in clinical trials reflects a desire by the competent authorities to achieve consistency in how RSI is managed ahead of implementing the safety reporting provisions in the EU Clinical Trials Regulation, which is estimated to come into effect in late 2018. (Also see "Elusive EU Clinical Trial Rules Slip Again -This Time To Late 2018" - Pink Sheet, 22 Dec, 2015.)
From the editors of Scrip Regulatory Affairs.