Expert comment: EU reaches landmark agreement on pharmaceutical legislation reform
On 11 December 2025, the Council of the EU and the European Parliament concluded negotiations on the long-awaited reform of the EU pharmaceutical legislation, marking the most significant overhaul in over two decades. The provisional agreement represents a major milestone in shaping the future of the EU regulatory framework for pharmaceuticals. Background First proposed by […]
Expert comment: Understanding the new EMA variation requirements
Long-awaited variation updates The recently updated EMA variation requirements reflect a major revision of both the legal framework and its practical guidance. It is essential to understand the distinct roles of the legally binding Variation Regulation and the accompanying EMA Variation Guideline, as well as the key drivers behind their revision and the practical implications […]
Expert comment: Promotional compliance – major updates in 2025 for the Nordic region
With 2025 coming to a close, we have seen several important updates to Nordic promotional compliance codes over the past year. This overview highlights the key developments affecting promotional activities in the Nordics and outlines their implications for pharmaceutical and healthcare stakeholders. Sweden – LER update On 29 September 2025, LIF’s ethical rules for the […]
Expert comment: EMA strengthens Scientific Advice process for medicines addressing public health threats
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) is strengthening its support for the development of promising medicines and vaccines against public health threats by introducing a new procedure for a combined scientific advice (SA) with input from the EMA, as well as clinical trial and ethics experts at national level. The overall goal […]
Expert comment: FAST-EU: Accelerating clinical trials to boost Europe’s competitiveness
EU struggles to attract clinical trials The EU’s appeal as a region for conducting clinical trials has declined, with the share of clinical trials sharply dropping over the past decade – from 22% in 2013 to 12% in 2023 (EFPIA 2024). Although progress has been made to reverse this trend through the implementation of the […]
Expert comment: The new FASS improves user experience
Fass (FASS) has, since 1966, been the central source of quality-assured pharmaceutical information in Sweden. 25 years ago, Fass went online for the first time. On November 8, the new Fass was launched, marking the most significant update and modernisation since its inception. From book to digital platformFounded in 1966 as a printed book for […]
Expert comment: Swissmedic introduces the Preliminary Decision Clarification Meeting for human medicinal products containing new active substances
In the course of the regulatory approval process, particularly for innovative products, situations often arise where a close dialogue with the authority is needed or beneficial, e.g. to clarify specific scientific issues or to agree on a certain response strategy to address (major) concerns that the authority has identified. With the newest revision of the […]
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 […]
Expert comment: PMS implementation, the final step of the SPOR journey
PMS is the last piece of the SPOR puzzle and recently EMA published an updated PMS Roadmap. PMS implementation has been in the works for several years and during 2025 the mapping of product data from SIAMED and XEVMPD is ongoing. During the initial migration to PMS, some fields will contain data, while others will […]
Expert comment: FDA to promptly publish issued CRLs to increase transparency
FDA has recently released a large number of redacted CRLs for both approved and unapproved New Drug Applications (NDAs) and Biologics License Applications (BLAs) through their database openFDA. In July more than 200 CRLs from 2020-2024 were published and in September a further 89 previous unpublished CRLs from 2024 were added. This marks a shift […]