Updated ICH E2D(R1) on post-approval safety data comes into effect in the EU
The updated ICH E2D(R1), which provides guidance on management and reporting of post-authorisation individual case safety reports, came into effect on 18th March 2026.
This is the first revision of ICH E2D(R1) in over 20 years.
HMA/EMA Guideline on good pharmacovigilance practice on pregnant and breastfeeding women and their children exposed in utero or via breastmilk
On 2 February 2026, the Heads of Medicines Agencies (HMA) together with the EMA, published a Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk. The Guidance provides direction concerning the conduct of pharmacovigilance processes in relation to pregnant or breastfeeding women and children exposed in utero or via milk to medicinal products.
Final text of the Pharma Package published
The final drafts of the proposed Directive and proposed Regulation have been published. The revised texts reflect the revisions proposed by the Council and the European Parliament and related compromise provisions. Formal adoption of the provisions is anticipated
ICH proposal for Guidelines for Extractables and Leachables
The ICH proposal for Guidelines for Extractables and Leachables has been published on the European Medicines Agency (EMA) website. The purpose of the draft Guideline is to provide a global framework for managing leachables in pharmaceutical products.
New Guidance Concerning Radiopharmaceuticals Supply Chain
The European Medicines Agency and the Heads of Medicines Agencies (HMA) have published Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals.