The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.
The Agency strongly encourages applicants and marketing authorisation holders to follow these guidelines. Applicants need to justify deviations from guidelines fully in their applications at the time of submission. Before that, they should seek scientific advice, to discuss any proposed deviations during medicine development.
The guidelines are complementary to European Pharmacopoeia monographs and chapters:
This section of the website updates and replaces the previous volume 3 of the rules governing medicinal products in the European Union (EudraLex), published by the European Commission.
The presentational order of the guidelines in this compilation was adapted following the introduction of the Common Technical Document (CTD) format in the EU.
The individual sections, and the rationale applied to each, are listed below (while the overall structure of Annex I to Directive 2001/83/EC has been followed, some adjustments have been made to account for the specific nature of certain areas or guidelines):
Search for scientific guidelines by category, type, topic and date.
Biological guidelines include information on active substance and finished product.
Because of the particular nature of these guidelines, the detailed CTD structure is not entirely applicable. Therefore, a distinction between biologicals, plasma-derived products and vaccines has also been added within the section 'manufacture, characterisation and control of the drug substance'.
Clinical efficacy and safety
Clinical efficacy and safety guidelines include information on various topics, from dermatologicals to biostatistics
Generally, the CTD structure has been followed. In addition, guidelines have been organised into therapeutic groups.
Herbal medicinal product guidelines
The Committee on Herbal Medicinal Products (HMPC) establishes EU herbal monographs (formerly Community herbal monographs). It also prepares the European Union list of herbal substances, preparations and combinations thereof, for use in traditional herbal medicinal products (formerly the Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products).
Although these documents are outside the scope of the procedure for EU guidelines, they are relevant for the registration and authorisation of herbal medicinal products.
The HMPC also establishes scientific EU guidelines addressing specific aspects and challenges with herbal medicinal products, particularly in the quality and safety areas. They are listed under a specific heading among multidisciplinary guidelines.
International Conference for Harmonisation (ICH) guidelines include information on quality, safety, efficacy and other topics.
These guidelines are harmonised through the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The CTD structure has been followed.
Multidisciplinary guidelines include information on biosimilars and other topics, from paediatrics to pharmacogenomics.
These guidelines apply to more than one specific area or have been prepared through the collaboration of several working parties. Where applicable, they are also listed in their related section (e.g. the 'quality' section).
Non-clinical guidelines include information on various topics, from toxicology to environmetnal risk assessment
The CTD structure has been followed.
Quality of medicines: questions and answers features answers to questions brought to the attention of the Quality Working Party (QWP) by marketing authorisation holders and/or EEA competent authorities
Quality guidelines include information on various topics, from active substance to lifecycle management.
As far as possible, CTD structure has been upheld. It has also been adapted - a different method of consolidation was considered to be more appropriate, as in the case of guidelines which apply to both the active substance and to the finished product (which, in the CTD format, are independent headings).
The compilation of European Commission and Agency guidelines contains:
- all valid guidelines originally published in volume 3;
- all valid guidelines published by the Agency since 1995;
- these guidelines' revisions and supplements.
Depending on each guideline's status, one or more of the following documents are available:
- concept paper;
- draft guideline;
- overview of comments received during the consultation period;
- adopted guideline.
However, only adopted guidelines form part of volume 3 of EudraLex.
Historical documents such as 'notes for guidance' are included in the compilation where they have the regulatory status of a guideline. Following the implementation of the procedure on EU guidelines, however, the use of these terms has been discontinued.
The compilation also includes other related documents, such as reflection papers, public statements and questions and answers. They provide additional information on topics of particular concern and/or clarification in areas where scientific knowledge is fast evolving or experience is limited.
Other guidelines, such as regulatory guidelines, good-manufacturing-practice guidelines and pharmacovigilance guidelines, were excluded from this re-organisation exercise. They continue to be published by the European Commission.