Regulatory round-up: 2 February 2026

2 February 2026

Europe’s human medicines system had the busiest week in this window, with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rolling out a batch of opinions from its late-January meeting. These are the sorts of decisions that quietly set the near-term agenda for launches and label expansions across the bloc.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) put out a prominent safety communication on GLP-1 medicines, pointing clinicians and patients toward clearer warnings and what to look for in the event of suspected pancreatitis. It also ties into the Yellow Card reporting push and ongoing efforts to sharpen post-marketing surveillance.

Country	Regulator	Candidate/product	Type of update	Details	Date	URL
EU	European Medicines Agency (EMA)	Multiple medicines	CHMP meeting highlights	CHMP reported six positive opinions on new medicines from its late-January meeting and backed a set of indication extensions for existing products. The opinions move candidates into the final EU decision stage, where the European Commission issues marketing authorizations.	30 Jan 2026	Source
UK	Medicines and Healthcare products Regulatory Agency (MHRA)	GLP-1 medicines	Safety update	MHRA updated product information for GLP-1 receptor agonists and dual GLP-1/GIP agonists to strengthen warnings on acute pancreatitis, including rare necrotizing and fatal reports. It also urged vigilance for symptoms and reinforced reporting via the Yellow Card system.	29 Jan 2026	Source
UK	Medicines and Healthcare products Regulatory Agency (MHRA)	GLP-1 medicines	Drug Safety Update (PDF)	Drug Safety Update set out the rationale for strengthened pancreatitis warnings across GLP-1 and dual GLP-1/GIP products and highlighted what prescribers should do if severe abdominal pain suggests pancreatitis. The notice is intended for broad clinical audiences, including primary care.	29 Jan 2026	Source
USA	Food and Drug Administration (FDA)	Multiple items	Human drugs: “What’s new” updates	FDA’s human-drugs update list posted several notable items in this window, including an approval entry and multiple policy/guidance updates. This page is the agency’s rolling index for drug approvals, safety communications, shortages, and related regulatory postings.	27 Jan 2026	Source
Canada	Health Canada	ICH lifecycle / analytical guidance	Policy/implementation notice	Health Canada posted drug product announcements focused on implementation of International Council for Harmonisation lifecycle and analytical guidance (including Q12 and Q14), alongside other system and policy communications. These updates are relevant for regulatory strategy and dossier maintenance.	26 Jan 2026	Source

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