Regulatory Rapporteur July/August 2026 – Contents
Therapeutics: Navigating diverse regulatory pathways
Drug development and regulatory pathways across therapeutic areas
The development of novel influenza drugs: Current regulatory challenges
Advancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction
Navigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
Environmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision
Medical device standards update: July 2026
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New MHRA framework sets out IMA pathway for rare disease therapies
21 May saw the MHRA unveil their draft rare disease framework, which is open for consultation until 30 of July. The new framework aims to adapt the regulatory framework for rare diseases, defined as affecting 1 in 50,000 or less people in the UK, as the current development model does ...
FAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
The first results from the (Facilitating and Accelerating Strategic Clinical Trials in the EU (FAST-EU) Pilot programme have been published by the Heads of Medicine Agency (HMA). Initial results indicate strong interest and engagement from stakeholders and the possibility of a 70-calendar-day approval timeline for clinical trial applications, indicating operational ...
European Commission publishes first joint clinical assessment under EU HTA regulation
The European Commission released the first joint clinical assessment (JCA) report on 9 June for the orphan medicine tovorafenib (Ojemda®), developed by Ipsen, used to treat paediatric low-grade glioma (a type of brain tumour), after being endorsed by all member states. This marks an important milestone for European cooperation on ...
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FDA launches Operation TrialBlazer to accelerate US clinical research
The US Food and Drug Administration (FDA) has announced plans to revitalise clinical research in the USA, as part of a US Department of Health and Human Services (HHS) initiative titled ‘Operation TrialBlazer’. The FDA has proposed multiple actions to achieve this aim, targeting both early- and late-stage clinical development. ...
European Commission targets high-risk AI with new draft guidelines
The European Commission has published draft guidelines to help developers determine whether their artificial intelligence (AI) qualifies as ‘high-risk’ under Article 6 of the AI Act. For developers of AI-enabled medical devices, the stakes are particularly high.
The HMA-EMA NDSG publishes report on AI in medicines development
Industry is bringing artificial intelligence (AI) to EU medicines regulators faster than ever before, with the number of new AI applications discussed with applicants as part of regulatory procedures having risen sharply, according to a new report by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA).
MHRA releases AI Airlock Phase 2 programme report
The AI Airlock Phase 2 Programme Report has been published by the MHRA, providing information on the insights and subsequent recommendations from Phase 2 of the initiative.
RegRapPod − InConversation with Magda Papadaki
InConversation talks portfolio careers with Magda Papadaki and Ming Ewe
RegRapPod − InConversation with Parexel
InConversation talks Joint Clinical Assessment with Sangeeta Budhia and Sinan Sarac
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