This section includes the European Medicines Agency's guidelines on the clinical efficacy and safety of medicines.
The 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.
Clinical efficacy and safety guidelines are provided for:
- 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/musculoskeletal system
- Nervous system
- Respiratory system
- Radiopharmaceuticals and diagnostic agents
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