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EU NCAs to Offer Simultaneous Scientific Advice for Drug Developers

Posted 20 January 2020 | By Zachary Brennan 

EU NCAs to Offer Simultaneous Scientific Advice for Drug Developers

As part of efforts to better align scientific advice across the EU, beginning 1 February, a dozen national competent authorities (NCAs) will participate in a pilot project to allow drug developers to obtain two NCA opinions simultaneously.

The multi-national discussions aim to provide two NCA opinions within one application, in addition to earlier opinions, better explanations for possibly conflicting opinions, increased interactions between NCAs and the potential for further alignment or clarification among NCAs on different regulatory positions and/or requirements.

“The objective of the concept is to establish a more efficient procedure based on the existing principles and structures for applicants seeking advice from different NCAs for the same questions and data package,” Belgium’s Federal Agency for Medicines and Health Products said.

The scope of the one-year pilot project’s scientific advice procedure is identical to that of single national scientific and regulatory advice procedures currently offered by NCAs. All types of applicants can apply for the pilot, including drug-device combination product developers, and special guidance will be provided for academia and small and medium-sized enterprises, especially with requests for early advice, according to NCAs.

At the end of 2020, the European Medicines Agency and Heads of Medicines Agencies are expected to provide an evaluation of the pilot in order to analyze the outcome and experiences gained from both the NCA’s and applicant’s perspectives. If the pilot shows sufficient demand and provides added value for applicants and regulators, further efforts will be initiated to optimize the process and possibly widen it in a next phase to have more than two NCAs participating in the advice simultaneously, the NCAs said.

The 12 NCA participants in the pilot project are: Austria (AGES), Belgium (FAHMP), Czech Republic (SUKL), Finland (FIMEA), Germany (PEI and BfArM), Hungary (OGYEI), Italy (AIFA), Norway (NOMA), Poland (URPL), Spain (AEMPS) and the UK (MHRA).

Guidance for applicants on a pilot project for simultaneous national scientific advice (SNSA)

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