Lead Story
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.
Industry news
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The US Food and Drug Administration has published draft guidance establishing four core validation principles for new approach methodologies in drug development, marking another milestone in its commitment to reducing animal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ACT EU issues draft guidance on clinical trials during emergencies
Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs).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.
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This industry news explores new FDA draft guidance that considers the use of the plausible mechanism framework to develop individualised medicines where randomised controlled trials are not feasible.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.
More news
FDA approves non-invasive device for pancreatic cancer treatment
DIN SPEC 91509: A milestone for structured, digital medical device documentation
MHRA points to clinical trial growth and faster assessment routes
MHRA invites Call for Evidence to assess AI regulation
FDA and EMA publish guiding principles of good AI practice in drug development
