Background Quality & Biologicals Quality (Chemical & Herbal) Biologicals Non-Clinical Clinical Efficacy & Safety Multidisciplinary

Scientific Guidelines for Human Medicinal Products

Introductory note on scientific guidelines

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) prepares scientific guidelines, in consultation with the competent authorities of the EU Member States, to help applicants prepare marketing-authorisation applications for medicinal products for human use.

Guidelines are intended to provide a basis for practical harmonisation of the manner in which the EU Member States and the EMEA interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy contained in the Community directives. They also help to ensure that applications for marketing authorisation are prepared in a manner that will be recognised as valid by the EMEA.

For the assurance of quality of medicinal products, guidelines are complementary instruments to European Pharmacopoeia monographs and chapters.

Compilation of European Commission and EMEA scientific guidelines relating to medicinal products for human use

Further to the implementation of the 'Procedure for European Union Guidelines' by the EMEA on 1 September 2005, an exercise has been launched to streamline the presentation on the EMEA website of existing and future guidelines for human and veterinary medicinal products.

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 currently valid guidelines originally published in Volume 3 and all currently valid guidelines published by the EMEA since 1995, plus their subsequent revisions and supplements. As well as adopted guidelines, it also includes concept papers, draft guidelines and overviews of comments received during the consultation on draft versions.

Depending on each guideline’s current 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, it should be noted that only adopted guidelines form part of EudraLex Volume 3.

The presentational order of the guidelines in this compilation has been 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 & Biologicals
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 & 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 products 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 European Union 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.

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 European Union 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, will continue to be published in the relevant working-party folders within the 'CHMP Working Parties' folder on the Human Medicines page.

Other guidelines, such as regulatory guidelines, GMP guidelines and pharmacovigilance guidelines, are excluded from this reorganisation exercise. They will continue to be published by the European Commission.

Reference:

1 Subsequently renamed Committee for Medicinal Products for Human Use (CHMP).
2 Subsequently renamed European Medicines Agency (EMEA).

The full text of the Directive is available through the European Union law portal, EUR-Lex .