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Acceptance of stakeholder comments during EMA scientific guidelines public consultations: legitimacy of the quadruple helix model of innovation
  • Inka Heikkinen,
  • Aimad Torqui
Inka Heikkinen
MSD Denmark

Corresponding Author:inkatuuli.heikkinen@merck.com

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Aimad Torqui
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Aim: Guidelines establish a framework for how therapeutics and vaccines are developed, assessed and approved. They influence which innovations are likely to be approved in the EU, and by that, they have an impact on the pipeline decisions taken by the research-based industry. This study analyses the level of acceptance for changes suggested by stakeholders within the authoring groups at the EMA. Methods: We looked at 87 guidelines from EMA Working Parties (WPs) launched for consultation between 2013-2017. Acceptance of stakeholder proposals and the time between the end of consultation and guideline adoption were studied as well as the openness of different Working Parties to accept changes. Results: Adoption of a guideline after the close of public consultation took at least 4 months, with average 12-16 months. The number of accepted and rejected comments were nearly equal across the stakeholders, with government having slightly higher chance for acceptance. Academia and NGOs had generally higher chances to have their comments accepted for general and indication-level guidelines. Government and individual companies had highest acceptance for molecule-level guidelines and trade associations for indication-level guidelines. The EMA WPs working with emerging technologies were more open to accept proposed changes. Conclusion: This pattern of progress in regulatory science at EMA demonstrates the essential and interrelated role of academia, industry, government and civil society – described as the quadruple helix model - to promote establishment of a strong innovation ecosystem in Europe. Further integration and utilisation of competences of each stakeholder is necessary for guideline development.
06 Apr 2022Submitted to British Journal of Clinical Pharmacology
22 Apr 2022Submission Checks Completed
22 Apr 2022Assigned to Editor
02 May 2022Reviewer(s) Assigned
24 May 2022Review(s) Completed, Editorial Evaluation Pending
25 May 2022Editorial Decision: Revise Major
23 Aug 20221st Revision Received
24 Aug 2022Submission Checks Completed
24 Aug 2022Assigned to Editor
24 Aug 2022Review(s) Completed, Editorial Evaluation Pending
06 Sep 2022Editorial Decision: Revise Minor
06 Sep 20222nd Revision Received
07 Sep 2022Submission Checks Completed
07 Sep 2022Assigned to Editor
07 Sep 2022Review(s) Completed, Editorial Evaluation Pending
08 Sep 2022Editorial Decision: Accept
09 Oct 2022Published in British Journal of Clinical Pharmacology. 10.1111/bcp.15542