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):
  1. Selection of topic and inclusion in the relevant work programme(s)
  2. Appointment of rapporteur (and,if necessary, co-rapporteur)
  3. Development of concept paper
  4. Adoption and release for consultation of concept paper
  5. Preparation of initial draft guideline
  6. Release for consultation of draft guideline
  7. Collection and assessment of comments
  8. Preparation of final version of guideline
  9. Adoption of final guideline for publication
  10. Implementation