REGULATORY · EMA

Adoption of Delegated Regulation under Ecodesign

On 9 February 2026, the EU adopted a delegated regulation under the Ecodesign for Sustainable Products Regulation (ESPR), focusing on sustainability in product design.

REGULATORY · MHRA

Consultation on CE-Marked Devices in Great Britain

The MHRA launched a consultation on 16 February 2026 regarding the indefinite recognition of CE-marked devices compliant with EU MDR/IVDR in Great Britain, open until 10 April 2026.

REGULATORY · EMA

Implementation of ICH E2D Guideline

EMA has released a strategy for implementing the ICH E2D guideline on post-approval safety data, effective from 18 March 2026.

ARTICLE

EMA's New Guidance on Post-Authorisation Variations

The European Medicines Agency (EMA) has published updated guidance on the classification of variations post-authorisation. This includes a Q&A on manufacturing processes, stability testing, and the implementation of the PACMP and PLCM...

NEWS

Overview of APAC Regulatory Changes

The APAC region continues to evolve its regulatory frameworks, focusing on harmonization and compliance with international standards, particularly in the medical device sector.

NEWS

Increased Collaboration Among APAC Regulators

Regulatory bodies in the APAC region are enhancing collaboration to streamline approval processes and share best practices, aiming for greater efficiency in market access.