EMA

Clinical Trials News from around the Globe

Clinical Trials News from around the Globe

With COVID-19 dominating clinical trials news, our latest industry update includes coverage of the key guidance documents issued by the regulators and much more. Compiled by Christina Hägglund, QA Manager, S-cubed Ltd. You can download the pdf of this update…
EMA Publishes Updated Guidance on Nitrosamines Impurities

EMA Publishes Updated Guidance on Nitrosamines Impurities

EMA Publishes a New Question and Answer Document for Marketing Authorisation Holders on the CHMP Opinion for the Article 5(3) referral on Nitrosamine Impurities in Human Medicinal Products (EMA/409815/2020) The European Medicines Agency (EMA) have published a new ‘question and…
Marketing Authorisation Holder GMP-related Responsibilities

Marketing Authorisation Holder GMP-related Responsibilities

Our Regulatory Affairs team have produced this article with the aim of summarising the key elements of the EMA Reflection Paper and the GMP-related responsibilities that apply to Marketing Authorisation Holders. The article also aims to assist our clients in…
Clinical Development Practices & Regulations

Clinical Development Practices & Regulations

Clinical Development Practices and Regulations are the main focus for our Q2 Industry Update. We also include important information about COVID-19, expertly compiled by Christina Hägglund, QA Manager, S-cubed Ltd. Read all the latest regulatory news here. You can download…
COVID-19: European Medicines Agency Updates

COVID-19: European Medicines Agency Updates

S-cubed's Regulatory Affairs team compiles the latest updates from the European Medicines Agency to the COVID-19 pandemic. The European Medicines Agency (EMA) continues to update guidance and procedures in response to the COVID-19 pandemic, including measures being put in place…