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  • Feature ArticlesFeature Articles

    January’s Regulatory Focus: Leadership in RA, expanding diversity, and more

    Feature articles during January focused on regulatory leadership, a novel approach to hiring regulatory professionals, expedited programs for reducing time to approval for certain drugs, and the Cuban biotechnology industry and its response to COVID-19. Keywords – assessment aid, breakthrough therapy, Cuba, diversity, ILAP, leadership, PRIME   Leadership, hiring, and expanding diversity Effective leadership in regulatory affairs is rooted in an understanding a...
  • Feature ArticlesFeature Articles

    Expedited pathways: Breakthrough therapy designation, PRIME, and innovative licensing & access

    Abstract Over the last decade, regulators have introduced initiatives to reduce time to approval for medicines that address an unmet medical need. This article compares the US Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD), the European Medicine’s Agency’s (EMA’s) PRIority MEdicines (PRIME) scheme, and the innovative licensing and access pathway (ILAP) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and reviews th...
  • RoundupsRoundups

    Euro Roundup: UK sets up group to involve patients in ILAP pathway

    UK sets up group to involve patients in Innovative Licensing and Access Pathway   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has formed a patient group to support its Innovative Licensing and Access Pathway (ILAP). MHRA set up the group to ensure that “patient views are an integral part of the ILAP ambition.”   UK officials shared details of ILAP late last year, describing how the pathway will accelerate time to market by enabling drug de...
  • Feature ArticlesFeature Articles

    The UK regulatory landscape post Brexit

    The withdrawal of the UK from the European Union was fully effective on 1 January 2021, with the Medicines and Healthcare products Regulatory Agency (MHRA) becoming the UK’s standalone medicines and medical devices regulator. Medicine developers need to be aware of the rules they now have to follow for getting their products approved for the UK market. MHRA has published extensive guidance, and this article aims to highlight the most relevant initiatives.   Introducti...
  • Regulatory NewsRegulatory News

    MHRA awards first ‘innovation passport’ under new pathway

    MSD's (Merck Sharp & Dohme (UK) Limited) investigational drug belzutifan on Friday became the first drug to be awarded an “innovation passport” under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) innovative licensing and access pathway (ILAP).   Belzutifan is being developed to treat adults with von Hippel-Lindau disease, a rare cancer-causing genetic disorder, and has been granted orphan designation in the EU and both orphan designation and br...