Nordic regulatory news highlights September 2025
30 September 2025 From the newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from September 2025. SWEDEN New European campaign stresses safe use of non-prescription medicines 15 September 2025A new awareness campaign from Europe’s medicines authorities reminds the public that over-the-counter medicines are not without risks. The […]
MHRA news highlights September 2025
30 September 2025 From the newsfeeds of the Medicines and Healthcare products Regulation Agency, Arex Advisor has rounded up a selection of highlights from September 2025. MHRA approves first new UTI antibiotic in nearly 30 years 28 August 2025The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised gepotidacin, the first new class of […]
FDA news highlights September 2025
30 September 2025 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of highlights from September 2025. FDA calls for child-resistant packaging of nicotine pouches 2 September 2025FDA has urged manufacturers of nicotine pouches to adopt child-resistant packaging following rising reports of accidental exposure. Between April […]
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 In July more than 200 CRLs from 2020-2024 were published and in September a further 89 previous unpublished CRLs from 2024 were added.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 […]
EU news highlights September 2025
30 September 2025 From the newsfeeds of the European Medicines Agency’s (EMA), the European Commission (EC) and the Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) , Arex Advisor has rounded up a selection of highlights from September 2025. EMA and WHO mark 10 years of regulatory collaboration 1 September 2025The European […]
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 […]