Medicine shortages: Why manufacturing is only part of the solution
In a recent interview with Swedish healthcare publication Dagens Medicin, Nelly Fransén, Expert Regulatory Affairs and specialist in pharmaceutical formulation, discussed the practical and regulatory considerations involved in producing pharmacy-compounded alternatives to transdermal oestrogen medicines in Sweden. In this article, she shares further insights into the complexity of solving medicine shortages.
FDA’s one-day inspection pilot: what to expect
The U.S. Food and Drug Administration (FDA) 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.
Whitepaper: European Biotech Act – Regulatory impact and implications for sponsors
This whitepaper provides a clear and concise overview of the Act’s background, intent, and the key pieces of regulatory legislation it is set to influence.
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.
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.
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 pharmaceutical ingredients (APIs) and medicinal products.
9 things to consider before starting a tech transfer
For global Regulatory Affairs Directors. A technology transfer can be the best decision for your manufacture – or, done wrong, it could be the worst. Our experts have identified 9 red flags to look out for before initiating a tech transfer. 1. No back-up manufacturing site Preferably, do not initiate a tech transfer unless a […]
Costly pitfalls to avoid in drug development
Costly pitfalls in drug development – and how to avoid them.