Scientific guidelines

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) 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 provide a basis for practical harmonisation of how the EU Member States and the Agency interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy that are 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. The Agency advises applicants to discuss any proposed deviations with EU regulators during medicine development through scientific advice.

For the assurance of the quality of medicines, 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 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 European Union. 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.

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 (HMPC) prepares the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products', and establishes Community 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, and are therefore listed under specific headings among the clinical 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.

Documents that do not have the status of a guideline, such as position papers, reflection papers or question-and-answer documents, continue to be published in the relevant working-party folders within CHMP: Working parties and other groups.

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.

Guidelines

• Quality guidelines
• Q&A on quality
• Biological guidelines
• Non-clinical guidelines
• Clinical efficacy and safety guidelines
• Multidisciplinary guidelines
• International Conference on Harmonisation (ICH) guidelines