European Medicines Agency (EMA) News Channel
Better protection of public health through strengthened EU system for medicines safetyThe European Medicines Agency has updated its guidance for pharmaceutical companies developing medicines for the treatment or prevention of diabetes. The guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus, published today, updates the previous document from 2002. It gives guidance on the clinical studies required to support the authorisation of new medicines for treating or preventing diabetes. The European Medicines Agency has released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines. The guideline updates the previous guidance from 2006, and explains the requirements for the manufacture and comparability testing for biological medicines claiming to be similar to another medicine already on the market. The European Medicines Agency has begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency's continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy. The European Medicines Agency released a reflection paper on the classification of advanced-therapy medicines for public consultation. The paper clarifies the legal basis for the classification of medicines as advanced therapies and provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tissue-engineered or combined medicines. It also gives details on the types of information that applicants need to submit to the Agency when applying for classification of their medicine as an advanced therapy, and discusses of some borderline cases and areas where scientific knowledge is limited or evolving rapidly. Following a successful pilot, the European Medicines Agency's eSubmission Gateway is now live for all applications for centralised marketing authorisations for human medicines. This is an important milestone in the Agency's long-term strategy for the electronic submission of applications, which aims to improve efficiency and decrease costs for applicants. The eSubmission Gateway is an electronic submission channel that allows applicants to submit documents supporting all types of applications for human medicines to the Agency securely over the internet in the Electronic Common Technical Document (eCTD) format. European Medicines Agency publishes reflection paper with practical guidance on the assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorisation applications submitted in the EU. The European Medicines Agency today published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities.