Regulatory Rapporteur May 2026 – Contents
The regulatory profession: Origins, career development and the road ahead
Bridging science and compliance: A career path from academia to regulatory medical writing
A career in veterinary regulatory affairs: Roles and competencies across the product lifecycle
The drug development lifecycle: Regulatory milestones and pathways for early-career professionals
An accidental profession: Finding your path in medical device regulatory affairs
Career growth in medical device regulatory affairs: A recruiter’s perspective
Rethinking regulatory talent development
How to build a portfolio career: Stepping beyond the regulatory swim lane
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Gene therapies, first-in-class medicines and label updates: CHMP delivers a busy April session
The Committee for Medicinal Products for Human Use’s April 2026 session covered significant ground, making fourteen positive decisions in four days. The outcomes have direct implications for lifecycle managers and regulatory teams across the EU.
MHRA publishes draft 2026 medical device regulations for GB market
Regulatory pathways for medical devices in Great Britain are set for further change, following the publication of new pre-market requirements by the Medicines and Healthcare products Regulatory Agency (MHRA). The proposals introduce new measures on reliance, traceability and classification as part of the evolving post-Brexit regulatory framework.
CVMP advances discussions on AMR and quality guidance
During the April 2026 session, the European Medicines Agency’s (EMA) Committee for Veterinary Medicinal Products (CVMP) addressed a range of regulatory and scientific topics covering authorised products, pharmacovigilance, antimicrobial resistance (AMR) and ongoing guideline development.
More news
Clinical trials amendment regulations to take effect from 28 April 2026
The UK will implement its major clinical trials regulatory overhaul on 28 April 2026, introducing faster approvals and a more flexible, risk-based system, although some areas of regulatory and ethical alignment still require careful consideration.
FDA advances commitment to moving beyond animal testing
The US Food and Drug Administration has published draft guidance establishing four core validation principles for new approach methodologies in drug development, marking another milestone in its commitment to reducing animal testing in drug safety assessment.
ACT EU issues draft guidance on clinical trials during emergencies
Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs). Public consultation is open until 30 April 2026.
FDA launches new consolidated adverse event reporting system
The US Food and Drug Administration has introduced a consolidated adverse event database spanning all regulated product categories, from medical products and devices to food, cosmetics and veterinary medicines, aiming to enhance cross-category safety surveillance.
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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