The European Medicines Agency was established in 1995 to oversee the scientific evaluation and the safety monitoring of medicines in the European Union. The remit of this European agency is to ensure public and animal health in all member states as well as in the countries of the European Economic Area (Norway, Iceland and Liechtenstein). The agency does this by assuring drug quality, safety and efficacy for about half a billion inhabitants. The EMA is located in London but will move to the Netherlands as a result of the UK leaving the EU. The mission of the EMA can be found on their http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000091.jsp&mid=WC0b01ac0580028a42. In this editorial, we will give a brief introduction to the functions of the EMA. Further information about the EMA mission, structure and activities as well as on how it interacts with academia can be found at http://www.ema.europa.eu/ema and in the hyperlinks provided in this editorial.
Provision of information to health care professionals is an important function of the EMA that is perhaps not widely appreciated by clinical pharmacologists and others involved in therapeutics. European Public Assessment Reports (EPAR) are a very rich source of information on new medicines that are available through a user‐friendly http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=&alreadyLoaded=true&isNewQuery=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&startLetter=B&keyword. EPAR's contain all the information that led to the application for marketing as well as safety and quality/production data.
An additional important information tool for any health professional involved in therapeutic or pharmacologic innovation is the wide range of subjects covered by http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001768.jsp&mid=WC0b01ac0580b18a3a. EMA scientific guidelines are EU Community documents that are intended to provide advice to companies applying for market authorization and competent authorities in member states.
The EMA clinical guidelines are developed through a process of consultation that is transparent, so guidelines on the EMA website firstly appear as concept papers or draft guidelines (which enter a period of consultation) and finally as adopted guidelines. Scientists from all member states have the right to comment. We do find that these comments are often adopted, so watching the consultation process is also of scientific value.
The catalogue of guidelines is categorized according to the http://www.ich.org/products/ctd.html (CTD) when they concern general issues and include the guidelines that are globally harmonized through the http://www.ich.org/home.html (ICH).
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79) prepares the scientific and clinical guidelines which we will cover in this series especially. The guidelines cover virtually all therapeutic areas (Box 1).
Box 1 Areas covered by the EMA guidelines and regulatory documents (hyperlinked directly to the relevant area).
Adopted guidelines reflect a harmonized European approach to a specific scientific issue and should reflect the most recent scientific knowledge. However, while EU regulations are mandatory for all members states and EU directives must be followed by national laws in line with the directive, EMA guidelines do not have legal force and alternative approaches may be taken, but these obviously require more justification.
This new series of the BJCP, developed in collaboration with the EMA, aims to address this issue by providing an annotated version of some relevant EMA guidelines and regulatory documents by experts. Hopefully this will help in promoting their diffusion and in opening a forum for discussion with our readers.
The first of this series appears in this issue of the BJCP, and the series will be continuously collected in a virtual issue of the journal. In this issue you will find the commentary on the http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500210825&mid=WC0b01ac058009a3dc that was adapted as a result of the death or disability of a number of subjects in a trial in France 1, 2. The commentary is written by Professor Joop van Gerven, Chairman of the Netherlands' Central Committee on Research Involving Human Subjects (CCMO) and Dr Milton Bonelli of the EMA 3. All future commentaries in the series will share the same format. They will start with a summary of the main points covered in the guideline and the most important messages emanating from it. Our experts will then give their motivated opinion on relevant and controversial issues in the guideline and where it may change current practice. Throughout the commentary, hyperlinks will guide you to the relevant sections of the guideline.
We hope this series will become a useful reference for everyone involved in scientific studies of medicines in man. This editorial also serves to welcome Professor Bonini as our EMA series special editor and to introduce a hopefully long‐lasting and productive collaboration between the EMA and the BJCP.
Competing Interests
There are no competing interests to declare.
Cohen, A. , and Bonini, S. (2018) Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP . Br J Clin Pharmacol, 84: 1399–1400. doi: 10.1111/bcp.13599.
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