Regulatory Rapporteur March 2026 – Contents
The innovation era: Where biology meets technology
Navigating regulatory pathways for live biotherapeutics in the US and EU: Challenges and opportunities
Cell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
Navigating Advanced Therapy Medicinal Product regulatory changes: European Medicines Agency and UK guidance updates
Beyond product approval: Bridging the gap between regulatory success and patient access for biosimilars
The EU’s Health Technology Assessment Regulation: Implementation one year on
WMA declarations: Helsinki in the spotlight and Taipei in the background
TOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
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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The US Food and Drug Administration has published draft guidance establishing four core validation principles for new approach methodologies in drug development, marking another milestone in its commitment to reducing animal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ACT EU issues draft guidance on clinical trials during emergencies
Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs).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.
More news
FDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
This industry news explores new FDA draft guidance that considers the use of the plausible mechanism framework to develop individualised medicines where randomised controlled trials are not feasible.
MHRA seeks views on indefinite acceptance of CE-marked medical devices
This industry news update summarises the MHRA proposals for indefinite recognition of CE-marked medical devices in Great Britain and the potential impact for health systems and patients.
New ICH M15 Guideline sets harmonised framework for MIDD
This industry news update gives details of the ICH M15 adoption and its aim to establish standardised good practice for the use of evidence derived from model-informed drug development.
FDA approves non-invasive device for pancreatic cancer treatment
This industry news update shares details of the FDA’s approval of Optune Pax, a medical device enabling treatment in a home setting.
RegRapPod − InConversation with Parexel
InConversation talks Joint Clinical Assessment with Sangeeta Budhia and Sinan Sarac
RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
InConversation talks careers with Zohra Nasir and Aksa Rahman
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