Regulatory update compiled by our experts
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EDQM publishes new guidance on reliance-based and fast-track assessment of CEP applications
Significant reduction in time to approval
Medical Device and In Vitro Diagnostics Regulations
Proposed amendments
Revision to the Guideline on the Chemistry of Active Substances
Effective September 2026
ICH M4Q(R2) Common Technical Document Quality Guideline
Major revision
Q1 2026 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
EU Paediatric Investigation Plan; mechanism of action
Potential for future change to Paediatric Investigation Plan (PIP) waivers following the introduction of the new Pharmaceutical Regulations
New UK Clinical Trial Regulations Transition
Transitional Arrangements for Clinical Trials
New UK Clinical Trial Regulations
The UK will undergo the biggest overhaul of clinical trials law in two decades.
Antimicrobial resistance
Problems and possible EU solutions
Q4 2025 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Orphan Medicinal Products in the EU
Summary of Orphan Drug Designation