REGULATORY · EMA

EMA's Roadmap for Electronic Product Information

The EMA has released a draft roadmap for the coordinated EU rollout of electronic product information (ePI) for human medicines. This initiative aims to ensure timely and accurate...

REGULATORY · EMA

New EU Legislation on Drug Safety and Innovation

The new EU pharmaceutical legislation expands EMA's oversight on drug safety and introduces measures to support innovation. This includes provisions for unlimited validity of centralised marketing authorisations unless...

REGULATORY · MHRA

MHRA Guidance on Diagnostic Radiopharmaceuticals

The MHRA has issued draft guidance allowing the production of diagnostic radiopharmaceuticals at sites with specials or investigational licenses, facilitating greater access to these critical products.

ARTICLE

EU Pharma Reform: Key Changes and Implications

The final texts of the new EU pharmaceutical regulation and directive were published in March 2026, marking a significant overhaul of the pharmaceutical lifecycle from development to surveillance. This reform aims to...

NEWS

EMA's Strategy for Implementing ICH E2D Guidelines

On March 12, 2026, the EMA published a strategy for implementing the revised ICH E2D guideline on post-approval safety data, effective from March 18, 2026. This aims to...

NEWS

Expansion of MDR Well Established Technologies List

The EU Commission's Delegated Regulation, published on March 20, 2026, expands the list of Well Established Technologies (WET) for implantables and class III devices, exempting them from clinical...

NEWS

EMA's Final Programming Document for 2026-2028

The EMA has published its final programming document for 2026-2028, which outlines strategies for enhancing early development support and facilitating rapid EU authorisations.