Week of 26 Oct 2026
26 Oct 2026 – 1 Nov 2026 · this week, updated as new items are published
- Documents 11
- Safety 1
- Authorisations 5
New and revised regulatory documents · 11
- US FDA 30 Oct 2026 Revised · Guidance
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1): Guidance for Industry - EMA 30 Oct 2026 Revised · Procedural guideline
List of centrally authorised products with safety-related changes to the product information - EMA 28 Oct 2026 New · Scientific guideline
Considerations regarding the implementation of ICH M13B on bioequivalence for immediate-release solid oral dosage forms - EMA 28 Oct 2026 Revised · Procedural guideline
Notice to sponsors on validation and qualification of computerised systems used in clinical trials - MHRA 27 Oct 2026 Revised · Detailed guide
Access, new active substance and biosimilar work sharing initiatives - US FDA 27 Oct 2026 New · Guidance
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management - EMA 27 Oct 2026 New · Scientific guideline
Tofacitinib, prolonged-release tablets, 11 mg product-specific bioequivalence guidance - MHRA 26 Oct 2026 New · Drug Safety Update
#MedSafetyWeek (2 to 8 November 2026): Don't ignore suspected side effects, report them! Updates to the Yellow Card website and app - EMA 26 Oct 2026 New · Scientific guideline
Semaglutide tablet 1.5, 4, 9, 25 and 50 mg product-specific bioequivalence guidance - EMA 26 Oct 2026 New · Scientific guideline
Niraparib hard capsules 100 mg and film-coated tablets 100 mg product-specific bioequivalence guidance - EMA 26 Oct 2026 New · Scientific guideline
Raltegravir product-specific bioequivalence guidance 400 mg and 600 mg film-coated tablet, 25 and 100 mg chewable tablet, 100 mg granules for oral suspension
Safety signals and safety-related labeling changes · 1
- MHRA 26 Oct 2026 #MedSafetyWeek (2 to 8 November 2026)
#MedSafetyWeek (2 to 8 November 2026): Don't ignore suspected side effects, report them! Updates to the Yellow Card website and app
Newly authorised or listed products
US FDA Approvals (original approval date) · 5
- TRANEXAMIC ACID ANDA tranexamic acid · ZYDUS LIFESCIENCES · 27 Oct 2026
- RIVAROXABAN ANDA rivaroxaban · TEVA PHARMS USA · 27 Oct 2026
- VALGANCICLOVIR HYDROCHLORIDE ANDA valganciclovir hydrochloride · ALEMBIC · 26 Oct 2026
- PROPRANOLOL HYDROCHLORIDE ANDA propranolol hydrochloride · SENORES PHARMS · 26 Oct 2026
- EPINEPHRINE ANDA epinephrine · GLAND · 26 Oct 2026
None this week: EMA, Health Canada, MHRA, SFDA.
Updated