The European Medicines Agency (EMA) has launched a public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database. The foundation of the EMA’s scientific perceptions is based on the outcomes of clinical trials implemented by different pharmaceutical companies. On the 1st of January, 2015, the Agency introduced a new policy which required publishing of clinical data. The main goal is to achieve sufficient transparency of clinical researches by providing details to the public. This way people will have the opportunity to access freely and easily extensive information about a specific programme. Precisely, the Agency policy applies to clinical reports of studies which exceed the area of the European Clinical Trial Regulation. Moreover, it includes studies which are carried out outside the EU but are submitted to EMA for marketing authorisation in Europe. But what exactly is the purpose of the European Medicines Agency consultation? The key objective is to reach out for the public opinion and get feedback on the previously made proposal related to the application of the transparency requirements set by the European Clinical Trial Regulation. What also stays in the core is the idea of a balanced and carefully shared information so that it can simultaneously answer the needs of the public to find out more but it can also match the needs of academia and industry in order to avoid potential confidential issues. In other words, this public consultation is linked to the practical application of transparency rules for the clinical trials portal and database which is established within and according to the European Clinical Trials Regulation. There is a document which sets out proposals which are now open for consultation. Comprised of several specific questions, it invites all stakeholders to review and comment on it. In different sections, stakeholders can share their personal views and arguments briefly regarding their preferred choice. What is more, they can also explain why according to them this is the best method which meets all the requirements and goals of the Clinical Trial Regulation. The deadline for comments is 18 February 2015. All the comments that European Medicines Agency will receive will be published on its website, you can send your comments with this template here – CTReg@ema.europa.eu
Comments