Regulatory Blog

Joint Clinical Assessments (JCA) provide a framework for assessing clinical evidence on the relative effects of health technologies on health outcomes at the EU level. For medicinal products within the scope of the Health Technology Assessment (HTA) Regulation, health technology developers need to provide information early in the process so that the JCA can be prepared and the relevant HTA procedures can begin. The European Commission has updated its guidance on the submissio

Improving the availability of medicines authorised in the European Union is a key priority for the European Medicines Regulatory Network. Supply chain disruptions can affect the continuity of medicine supply, making it important for Marketing Authorisation Holders (MAHs) to identify potential risks and establish measures to reduce the likelihood of shortages. The European Medicines Agency (EMA) has published guidance and a template for industry on implementing Shortage Preven

Clinical trials may need to be changed during their lifecycle because of developments in trial design, participant safety, medicines, scientific information, or trial administration. The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance, Clinical trials for medicines: modifying a clinical trial approval, explaining the different types of modifications that can be made to a clinical trial approval. The amended Clinical Trials Regulations took fu