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: 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 […]
Expert comment: Swissmedic and swissethics position paper on safety considerations of FIH/early phase for clinical trials
Embarking on a First-in-Human (FIH) clinical trial is a pivotal moment in drug development, where scientific innovation meets ethical responsibility. For sponsors, this phase demands not only strategic planning but also commitment to participant safety, regulatory compliance, and data integrity. A guidance document published by Swissmedic and swissethics in September 2025 summarizes key sponsor and […]