Week of 5 Oct 2026
5 Oct 2026 – 11 Oct 2026
- Documents 18
- Safety 1
- Authorisations 8
New and revised regulatory documents · 18
- MHRA 10 Oct 2026 Details changed · Detailed guide
Electronic Application Forms (eAF) for UK medicines licensing applications - MHRA 10 Oct 2026 Details changed · Guidance
International Recognition Procedure - MHRA 10 Oct 2026 New · Guidance
MHRA Real-World Evidence: knowledge and guidance - MHRA 10 Oct 2026 Details changed · Detailed guide
Find product information about medicines - US FDA 10 Oct 2026 Details changed · Guidance
Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry - US FDA 10 Oct 2026 Details changed · Guidance
Study Data Technical Conformance Guide - Technical Specifications Document - US FDA 10 Oct 2026 Details changed · Guidance
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers - EMA 10 Oct 2026 New · Scientific guideline
Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products - EMA 10 Oct 2026 New · Safety communication (DHPC)
Direct healthcare professional communication (DHPC): Ocrevus (ocrelizumab): New risk of drug-induced liver injury and recommendations on monitoring of liver function before and during treatment - EMA 10 Oct 2026 New · Procedural guideline
Questions and answers on the PIP compliance verification procedure at EMA, and on paediatric rewards - ICH 6 Oct 2026 Published · News
ICH Training Library Sees Addition of New Materials Covering 11 Harmonised Guidelines - EMA 6 Oct 2026 Revised · Template / form
Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical - EMA 6 Oct 2026 Revised · Procedural guideline
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - EMA 6 Oct 2026 Revised · Procedural guideline
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes - EMA 6 Oct 2026 Revised · Procedural guideline
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure - EMA 6 Oct 2026 Revised · Procedural guideline
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes - EMA 6 Oct 2026 Published · Scientific guideline
Concept paper on the guideline revision on good pharmacogenomic practice - MHRA 5 Oct 2026 Published · Detailed guide
Medicines: apply for a variation to your marketing authorisation
Changes to documents already listed · 4
- US FDA 10 Oct 2026 Status changed
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers - EMA 10 Oct 2026 No longer in the index
Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards - SFDA 8 Oct 2026 File replaced
Classification table of violations and penalties under the Law of Pharmaceutical and Herbal Establishments and Products and its Implementing Regulations - SFDA 8 Oct 2026 File replaced
Conditions and requirements for obtaining permits for drugs, pharmaceuticals, and cosmetics products for individuals for personal use
Safety signals and safety-related labeling changes · 1
- US FDA 6 Oct 2026 Sertraline Hydrochloride
SERTRALINE HYDROCHLORIDE — safety-related labeling change
Newly authorised or listed products
US FDA Approvals (original approval date) · 8
- WELTRUZA NDA olanzapine · TEVA NEUROSCIENCE INC · 8 Oct 2026
- BREZTRI AEROSPHERE NDA budesonide, glycopyrrolate, and formoterol fumarate · ASTRAZENECA AB · 8 Oct 2026
- MIRABEGRON ANDA mirabegron · CREEKWOOD PHARMS · 7 Oct 2026
- HYDROCHLOROTHIAZIDE ANDA hydrochlorothiazide · RUBICON RESEARCH · 7 Oct 2026
- FIDAXOMICIN ANDA fidaxomicin · HIKMA · 7 Oct 2026
- SUGAMMADEX SODIUM ANDA sugammadex sodium · SHANDONG · 6 Oct 2026
- SOLRIAMFETOL HYDROCHLORIDE ANDA solriamfetol hydrochloride · AUROBINDO PHARMA LTD · 6 Oct 2026
- DESFLURANE ANDA desflurane · PIRAMAL CRITICAL · 5 Oct 2026
None this week: EMA, Health Canada, MHRA, SFDA.
Updated