Regulatory Rapporteur July/August 2026 – Contents
Therapeutics: Navigating diverse regulatory pathways
Drug development and regulatory pathways across therapeutic areas
The development of novel influenza drugs: Current regulatory challenges
Advancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction
Navigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
Environmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision
Medical device standards update: July 2026
- Previous
- Next
CHMP July meeting brings first-of-its-kind eye implant and oral psoriasis breakthrough
At its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for marketing authorisation (three generics, one biosimilar, and eight extensions of indication), while issuing negative opinions on three applications.
CVMP June 2026 meeting update: Vaccines, guideline reviews and an AMR strategy refresh
The Committee for Veterinary Medicinal Products (CVMP) met on 16-18 June 2026. Alongside its usual product decisions, the Committee advanced two guideline reviews for sponsors working on vaccines and other immunological products.
FDA launches new guidance on development of psychedelic drugs to treat medical conditions
The US Food and Drug Administration (FDA) has issued its final guidance for drug development programmes evaluating the therapeutic potential of psychedelic drugs.
More news
USP 2025 Annual Drug Shortages Report: Shortages decline but duration increases
In June 2026, the United States Pharmacopeia (USP) released their 2025 Annual Drug Shortages Report, reviewing trends in drug shortages affecting the United States.
EU roadmap sets out 22 actions to phase out animal testing in chemical safety assessment
The European Commission has released a long-awaited roadmap towards phasing out animal testing for chemical safety assessments, having pledged to develop such an initiative in response to the European citizen’s initiative titled ‘Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing’, which was submitted to the Commission back ...
New MHRA framework sets out IMA pathway for rare disease therapies
The MHRA has revealed its draft rare disease framework, open for consultation until 30 July. The current development model does not always suit the conditions for rare diseases as they require greater flexibility in how they are evaluated. The framework emphasises earlier engagement with regulators, flexible evidence requirements, patient centricity, ...
FAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
The first results from the Facilitating and Accelerating Strategic Clinical Trials in the EU (FAST-EU) Pilot programme have been published by the Heads of Medicine Agency (HMA). Initial results indicate strong interest and engagement from stakeholders and the possibility of a 70-calendar-day approval timeline for clinical trial applications, indicating ...
RegRapPod − InConversation with Aman Khera
InConversation talks about opportunities and disruptors within the regulatory affairs industry with Aman Khera
RegRapPod − InConversation with Magda Papadaki
InConversation talks portfolio careers with Magda Papadaki and Ming Ewe
- Previous
- Next
The Organisation for Professionals in Regulatory Affairs
- Contact us
- Copyright © 2015-2026 The Organisation for Professionals in Regulatory Affairs Ltd. t/a Regulatory Rapporteur - All rights reserved