2. Legislative documents governing medicines regulation

The rules given in regulations, directives and national law are not always very detailed. Therefore, both industry and regulatory authorities may need more detailed information on precisely what they should do and how.

 The European Medicines Agency and the European Commission have developed a large number of detailed documents giving the required guidance; they are called guidelines

A guideline is a document providing guidance on the scientific or regulatory aspects of the development of medicines and applications for marketing authorization among others. Although guidelines are not legally binding, applicants need to provide sound justification for any deviations.

Guidelines are very important tools for companies and regulators in their daily work, and are an important advocacy tool for patient organisations. When a company plans the development and establishes the documentation needed for a new medicine, they should carefully consider all recommendations of the guidelines. When regulators assess the documentation, they check whether the company has respected relevant guidelines (see also below “Implementation and status”).