Week of 12 Oct 2026
12 Oct 2026 – 18 Oct 2026 · this week, updated as new items are published
- Documents 12
- Safety 1
- Authorisations 0
New and revised regulatory documents · 12
- SFDA 15 Oct 2026 New · Circular
تعميم الالتزام بتطبيق الأنظمة والتعليمات المنشورة على موقع الهيئة الالكتروني (Arabic) - MHRA 15 Oct 2026 New · Drug Safety Update
Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction - MHRA 15 Oct 2026 Details changed · Detailed guide
Safety Public Assessment Reports - MHRA 15 Oct 2026 New · Guidance
Antidepressants: use and safety - MHRA 15 Oct 2026 Details changed · Detailed guide
Access, new active substance and biosimilar work sharing initiatives - MHRA 15 Oct 2026 New · Guidance
MHRA Strategy to 2030: What it means for you - MHRA 15 Oct 2026 Details changed · Detailed guide
Medicines: apply for a variation to your marketing authorisation - US FDA 15 Oct 2026 Details changed · Guidance
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for Industry - US FDA 15 Oct 2026 Details changed · Guidance
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry - EMA 15 Oct 2026 New · Scientific guideline
Concept paper on the need for the guideline on the clinical investigation of medicinal products for the treatment of inherited retinal dystrophies - EMA 15 Oct 2026 New · Scientific guideline
VICH GL34: Biologicals: testing for the detection of Mycoplasma contamination - EMA 13 Oct 2026 Revised · Template / form
Voluntary data submission (VDS) pilot application form
Changes to documents already listed · 1
- MHRA 15 Oct 2026 No longer in the index
SSRIs and SNRIs: use and safety
Safety signals and safety-related labeling changes · 1
Newly authorised or listed products
None this week: US FDA, EMA, Health Canada, MHRA, SFDA.
Updated