Regulatory Affairs

Regulatory Rapporteur – June 2026

Regulatory Rapporteur June 2026 – Contents

Lifecycle management: Enhancing regulatory agility

Navigating divergence: Practical lessons from the UK lifecycle management of licences

The use of CEPs for API registration when global regulatory implementation pathways are not aligned

Driving efficiencies in global submissions through RIMS: Practical perspectives from industry

Enhancing post-market surveillance with Artificial Intelligence and predictive analytics

From gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation

Considerations in building and maintaining regulatory intelligence

Regulatory Rapporteur June 2026 – Contents
Lifecycle management: Enhancing regulatory agility
Navigating divergence: Practical lessons from the UK lifecycle management of licences
The use of CEPs for API registration when global regulatory implementation pathways are not aligned
Driving efficiencies in global submissions through RIMS: Practical perspectives from industry
Enhancing post-market surveillance with Artificial Intelligence and predictive analytics
From gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
Considerations in building and maintaining regulatory intelligence

Industry News

EMA recommends marketing authorisation extension for Wegovy tablets
The European Medicines Agency (EMA) has endorsed an extension to the marketing authorisation of Wegovy (semaglutide) in the EU for weight management. The extension enables the use of tablets, making it the first glucagon-like peptide (GLP-1) receptor agonist for weight management developed for oral use.
Harmonisation, fast track and reliance activities in focus at recent EDQM meetings
Leaders from the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is home to the European Pharmacopoeia (PhEur), participated in two public outreach events in May 2026. The first was on pharmacopoeial harmonisation in collaboration with United States Pharmacopoeia (USP), and the second on fast track and ...
EMA launches pilot to support breakthrough medical devices
The European Medicines Agency (EMA) has launched a pilot programme to support the development of breakthrough medical devices in the EU. This tests a new regulatory pathway that supports patient access to highly innovative technologies while maintaining rigorous safety and performance standards and will offer enhanced support for ...

More news

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.