Regulatory Blog

Paediatric drug development remains one of the most complex regulatory areas in the pharmaceutical landscape. Scientific uncertainty, evolving clinical insights, and gaps in early evidence often make it difficult for developers to design complete paediatric programmes at the initial stages of development. Recognising these challenges, the European Medicines Agency (EMA) has introduced a specialised mechanism known as the stepwise Paediatric Investigation Plan (sPIP) , formall

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated the section 3.1: 'Implementation of new guidelines' through its official guidance titled Medicines: Apply for a Variation to your Marketing Authorisation   — a key reference for MA holders operating in the UK regulatory ecosystem. A variation is any change to the terms of an existing marketing authorisation, from simple administrative updates to changes that may affect quality, safety or efficacy. T

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