FDA’s one-day inspection pilot: what to expect
The U.S. Food and Drug Administration (FDA) on May 6th, 2026, announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient. The pilot program has quietly already been initiated. In essence FDA conducts shorter and more focused screening assessments to complement the […]
2025 CMDh Activities – What matters for industry stakeholders?
In November 2025 the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) celebrated its 20th anniversary, reflecting on achievements so far, and future challenges. CMDh has summarized this event and their other activities in 2025. Here are some highlights: EU pharmaceutical legislation A major milestone in 2025 was the provisional political agreement […]
CMDh – the road ahead to 2028
The Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) has recently published its Multi-annual Workplan to 2028 , outlining its priorities across four main areas: Optimisation of procedures – described more in detail below Information technology and digitalisation – leveraging digital tools to improve efficiency and promote the use of AI where […]
Expert comment: EMA to strengthen the PRIME scheme with three new features
On 18 March 2026, the European Medicines Agency (EMA) published its plans to implement three new PRIME scheme features following a successful two-year pilot. These 3 new pilot features had been launched in April 2023 to fulfil recommendations for improvement of the PRIority Medicines (PRIME) scheme after reviewing the first 5 years of experience. These three […]
Expert comment: EU pharma legislation reform – implications for orphan medicines
On 18 Mar 2026, the EU pharma legislation reform got one step closer to formal adoption, with the approval of the outcome of the related interinstitutional negotiations by the European Parliament’s Committee on Public Health (SANT). In this article, we focus on the impact of this EU pharma legislation reform with regards to orphan medicinal […]
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 […]
Expert comment: European Biotech Act to strengthen biotechnology and manufacturing sectors
On 16 December 2025 the European Commission published a proposal for a framework of measures to strengthen the Union’s biotechnology and biomanufacturing sectors particularly in the area of health; the so-called Biotech Act. Background EU has a strong scientific research base in biotechnology but is facing issues with taking the early-stage research of these products […]
Expert comment: EMA recommendations for human medicines in 2025
The European Medicines Agency has published statistics on human medicines approval from the past year. The full report can be accessed here. New approval recommendations In 2025, 104 new medicines were recommended for marketing authorisation with 38 of these having new active substances not previously authorised in the Union. These numbers are slightly lower than […]