Effective September 2026
Articles filtered by tag
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
Aligned pathway
Parallel decision making by MHRA and NICE
Q3 2025 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
PRIME at the EMA
Summary and metrics for PRIME