Guideline development process
Scientific guidelines issued by the European Medicines Agency are
normally developed in accordance with the following steps [3] (see
table 1 for relevant timelines):
- Selection of topic and inclusion in the relevant work programme(s)
- Appointment of rapporteur (and,if necessary, co-rapporteur)
- Development of concept paper
- Adoption and release for consultation of concept paper
- Preparation of initial draft guideline
- Release for consultation of draft guideline
- Collection and assessment of comments
- Preparation of final version of guideline
- Adoption of final guideline for publication
- Implementation