Regulatory Affairs

Regulatory Rapporteur – April 2026

Regulatory Rapporteur April 2026 – Contents

Access to medicines: From approval to
patient-centred delivery

Regulatory affairs as a strategic function in market access of medicinal products: Pre‑COVID-19 context, COVID-19 acceleration and post‑COVID-19 convergence across 11 markets

Emergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions

The regulatory valuation of patient experience data in rare diseases: A review of FDA and EMA labelling outcomes and methodological determinants

Beyond borders: Strengthening regional regulatory frameworks to end substandard and falsified medicines in Africa

Plain language results in UK clinical trials: Navigating new regulatory requirements and practical challenges

The strategic role of Regulatory Operations in digital transformation success

Lean Six Sigma in post-market surveillance: Insights for EU 2017/745 MDR Article 88 and Great Britain SI 2024/1368 (44ZN) trend reporting compliance

Regulatory Rapporteur April 2026 – Contents
Access to medicines: From approval to
patient-centred delivery
Regulatory affairs as a strategic function in market access of medicinal products: Pre‑COVID-19 context, COVID-19 acceleration and post‑COVID-19 convergence across 11 markets
Emergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
The regulatory valuation of patient experience data in rare diseases: A review of FDA and EMA labelling outcomes and methodological determinants
Beyond borders: Strengthening regional regulatory frameworks to end substandard and falsified medicines in Africa
Plain language results in UK clinical trials: Navigating new regulatory requirements and practical challenges
The strategic role of Regulatory Operations in digital transformation success
Lean Six Sigma in post-market surveillance: Insights for EU 2017/745 MDR Article 88 and Great Britain SI 2024/1368 (44ZN) trend reporting compliance

Industry 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.

More news

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.

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