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:
- Status of European Medicines Agency scientific guidelines and European Pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinal products
Compilation of European Commission and Agency guidelines
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. It 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.
The presentational order of the guidelines in this compilation was adapted following the introduction of the Common Technical Document (CTD) format in the EU. 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.
The following rationale has been applied for the individual sections:
- Quality: As far as possible, the structure of the CTD has been followed. The structure has been adapted where 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).
- Biologicals: 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'.
- Non-clinical: The CTD structure has been followed.
- Clinical efficacy and safety: Generally, the CTD structure has been followed. In addition, guidelines have been organised into therapeutic groups.
- ICH: This section includes guidelines that are harmonised through the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The CTD structure has been followed.
- Multidisciplinary: This section contains guidelines that apply to more than one specific area or have been prepared through the collaboration of several working parties. Where applicable, these guidelines are also listed in the specific section to which they relate (e.g. the 'quality' section).
- Herbal medicinal product guidelines: The Committee on Herbal Medicinal Products prepares the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products', and establishes Communiy herbal monographs. Although these documents are excluded from the scope of the procedure for EU guidelines, they have relevance for the registration as well as the authorisation of herbal medicinal products. Therefore, they are listed under a specific heading among multidisciplinary guidelines.
Related document types
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.