Regulatory Blog

The South African Health Products Regulatory Authority (SAHPRA) has released the Guidelines to Good Manufacturing Practice for Medicines , effective 17 November 2025. This updated guideline aligns South Africa with the latest PIC/S GMP standards and strengthens regulatory expectations for manufacturers, importers, exporters, and distributors operating within the South African market. GMP is a system ensuring that medicinal products are consistently produced and controlled

The European Medicines Agency (EMA) has published the Draft Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trial s , a major methodological update replacing earlier guidance documents and modernising expectations for confirmatory clinical trial design. This new guidance introduces updated statistical concepts, integrates the ICH E9(R1) estimand framework, and clarifies how sponsors should design, analyse, and interpret non-inferiority and equivalence tri

The European Medicines Agency (EMA) recently published new guidance titled “ Guidance for applicants: the ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA ) ”, outlining how sponsors and applicants can benefit from harmonised scientific advice to accelerate clinical trial authorisation across the EU. 1. What the SA-CTA Scientific Advice Is The guidance explains that the SA-CTA scientific advice is a specialised type of EMA advice developed under th