Multidisciplinary guidelines

The European Medicines Agency's (EMA) multidisciplinary guidelines on the development of human medicines help applicants prepare marketing authorisation applications.

Multidisciplinary guidelines reflect a harmonised approach of EMA and EU Member States on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in EU directives.

EMA strongly encourages applicants and marketing authorisation holders to follow these guidelines. They should:

• seek scientific advice, to discuss any proposed deviations during medicine development;
• be able to justify deviations from guidelines fully in their applications at the time of submission.

EMA makes multidisciplinary guidelines available for various fields, from vaccines to artificial intelligence (AI). Find a full list of EMA multidisciplinary guidelines under 'In this section' on this page.

For more information, see:

• Scientific guidelines

In this section

• Artificial intelligence (AI)
• Biosimilars
• Cell therapy and tissue engineering
• Gene therapy
• Herbal medicinal products
• Nanomedicines
• Nasal products
• Orally inhaled products
• Paediatrics
• Patient experience data
• Pharmacogenomics
• Vaccines