Expert comment: EMA’s stepwise PIP – Toward regulatory integration after successful pilot
Following the positive review of the stepwise paediatric investigation plan (sPIP) pilot, first published in February 2026, the European Medicines Agency (EMA) is planning to conclude the pilot phase and integrate the sPIP framework into the existing paediatric regulatory landscape on a voluntary basis. A conventional, i.e., fully defined, PIP at initial submission should however […]
Expert comment: Revision of GMP Annex 15 – What does it mean for manufacturers?
The European Medicines Agency has released a concept paper for revision of GMP Annex 15. Annex 15 is currently intended for used by active substance manufacturers as an optional supplementary guidance to the requirements set out in EudraLex, Volume 4, Part II. However, in June 2020 the report “Lessons learnt from presence of N-nitrosamine impurities […]
Expert comment: Updated EU pharmacovigilance regulation – What has changed?
On 12 February 2026, the updated EU pharmacovigilance regulation became fully implemented. This regulation contains several important changes aimed at improving efficiency, clarity and compliance within pharmacovigilance systems. Below is a summary of some of the key updates. Key updates 1. Pharmacovigilance System Master File (PSMF)Only significant deviations from established pharmacovigilance procedures, along with their […]
Nordic regulatory news highlights February 2026
From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from the past month. SWEDEN Proposals aim to ease patient access during medicine shortages 17 February 2026In its final report on measures to prevent and manage supply and shortage situations, the Swedish Medical Products Agency presents […]
Swissmedic news highlights February 2026
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from the past month. Swissmedic reports rise in illegal medicine imports in 2025 16 February 2026Swissmedic recorded a 17% increase in illegal medicinal product imports in 2025 compared with 2024, handling 6,647 consignments in collaboration with the Federal Office for Customs […]
MHRA regulatory news highlights February 2026
From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has rounded up a selection of highlights from the past month. MHRA clarifies pharmacovigilance expectations under updated CIR 520/2012 9 February 2026The MHRA has issued updated guidance for UK Marketing Authorisation Holders on the application of revised pharmacovigilance provisions set […]
FDA regulatory news highlights February 2026
From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has rounded up a selection of regulatory highlights from the past month. FDA revises policy on ‘no artificial colors’ claims 5 February 2026The FDA has introduced a new approach allowing food companies to label products as containing ‘no artificial colors’ if […]