The European Medicines Agency’s Committees prepare 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. Among them, EACPT is in a privileged position to contribute to the drafting process of Clinical efficacy and safety guidelines and some multidisciplinary guidelines during the 3-6 month period of release for consultation.
EACPT Associate Members are encouraged to express interest and expertise on one or more of the following topics, so that working groups can be established for the different scientific areas, taking care of ensuring a high scientific quality contribution from EACPT to the CHMP Guidelines drafting process. The task of these working groups will be coordinated by a Regulatory Responsible EACPT member appointed by the EACPT Executive Committee. Groups will report on their activity to the Executive Committee on a yearly basis and to the EACPT Council every other year.
The Regulatory Responsible Team will highlight on a monthly basis new guidelines entering their release-for-consultation period and will appoint the working groups on the basis of the expression of interest.
Clinical Safety and Efficacy Guidelines
- Clinical pharmacology and pharmacokinetics
- Alimentary tract and metabolism
- Blood and blood forming organs
- Blood products (including biotechnological alternatives)
- Cardiovascular system
- Genito-urinary system and sex hormones
- Anti-infectives for systemic use
- Antineoplastic and immunomodulating agents
- Rheumatology/Musculo-skeletal system
- Nervous system
- Respiratory system
- Herbal medicinal products
- Information on medicinal products
- Radiopharmaceuticals and diagnostic agents