Regulatory Blog

Pharmacovigilance plays a critical role in protecting public health by enabling the timely identification, assessment, and management of medicine safety concerns. Accurate reporting of adverse drug reactions (ADRs) and Adverse Events Following Immunisation (AEFIs) allows regulatory authorities to continuously monitor the benefit-risk profile of authorised medicines and implement appropriate regulatory actions when necessary. To strengthen electronic pharmacovigilance reportin

Artificial Intelligence (AI) is rapidly transforming drug development by enabling more efficient data analysis, predictive modelling, and evidence-based decision-making. Early-phase clinical trials, particularly Phase 1 studies, represent one of the most challenging stages of drug development due to uncertainties surrounding dose selection, patient recruitment, safety monitoring, and progression decisions. Improving the efficiency of these trials has the potential to accelera

Marketing Authorisations (MAs) require updates throughout a medicine's lifecycle to reflect changes in manufacturing, quality, safety, efficacy, product information, or administrative details. To ensure that these changes are appropriately assessed and approved while maintaining product quality and patient safety, the Medicines and Healthcare products Regulatory Agency (MHRA) provides detailed guidance on applying for variations to UK Marketing Authorisations. The MHRA guidan