Revised FIH EMA Guideline: Disruptive or Constructive?

The EUropean Federation for Exploratory MEdicines Development (EUFEMED, is a not-for-profit association that aims to improve the early phase clinical drug development process in Europe [1].

On the 19th September 2018, EUFEMED organised a meeting in Leuven, Belgium entitled ‘The new FIH EMA guideline: Disruptive or constructive?’ to provide a forum to discuss their operational impact. The revised EMA Guideline on strategies to identify and mitigate risks for first-in-human (FIH) and early clinical trials with investigational products was published on 20th July 2017, coming into operation on 1 February, 2018 [2]. As such, it was implicated that many early-phase stakeholders will have gathered first-hand experience of working within the guidelines and could now draw an opinion on its overall value.

This well-attended congress was organised to provide a formal opportunity to harvest learnings in a structured setting that each of the stakeholders may have obtained and insight into any difficulties that may have arrived from the updated early recommendations. Representatives were present from the pharmaceutical industry, clinical research organisations and academia across Europe, as well as officers from all the major regulatory agencies. The meeting was opened by ex-EUFEMED president and local host, Prof. Jan de Hoon (pictured), who provided an overview of comments on 'Concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human (FIH) clinical trials with investigational medicinal products’ (EMA/CHMP/446302/2016) [2]. A unique opportunity was provided to assess the impact of the day's interactions through the use of a live electronic voting system. And these opinions on the guidelines were compared with the findings of a survey on the opinions of the wider EUFEMED membership that was conducted earlier in the year.

The congress was opened by a summary of the current early phase landscape as seen by each of the member regulatory agencies. The audience was invited to directly interact with the panel of regulators, leading to fruitful discussions to identify possible future risks for those taking part in first-in-human and early clinical trials and hopefully mitigate them. When it came to the final voting, determining the overall 'opinion' on the guidelines, the majority of attendees (51%) felt that they included both constructive and disruptive aspects, whereas nearly half (48%) felt that they were broadly constructive. Stefano Possano of the European Medicines Agency summarised the opinion of the majority of attendees when he said, "This kind of forum is required to avoid misunderstandings in the interpretation of the first-in-human guidance, we should come back and reconvene more regularly."

The EUFEMED executive thanks attendees and speakers for contributing to the great success of this forum.

  1. Van Bortel L, et al. EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management. Front Pharmacol. 2018 Jan 17;8:901. doi: 10.3389/fphar.2017.00901.


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