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 […]
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: 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: AI in Pharma – considerations of Annex 22
Artificial Intelligence (AI) is increasingly being adopted in pharmaceutical industry, offering new opportunities to save time and enhance quality assurance. To ensure these technologies are used responsibly, the European Commission has drafted the new Annex 22 to the EU GMP Guidelines – providing a regulatory framework for AI applications used in the manufacture of active […]