4.1 Implementation and status of CHMP guidelines

Implementation and status of CHMP guidelines

The status of a guideline is different from that of a regulation, directive or national law. A guideline offers guidance. This means industry is recommended to follow the guideline, for example when preparing the documentation for a new medicine. New guidelines will normally be implemented six months after adoption by the CHMP. However, medicine development is a lengthy process. A guideline only applies to development or research started after the date of implementation of the given guideline.

As mentioned, a guideline is not legally binding. In specific situations, it may be inappropriate to follow a guideline during the development of a new medicine. What if a company finds this to be the case? The company needs to provide sound scientific argumentation for any deviation. If they do so correctly, the regulators should be willing to accept it. The assessor(s) involved will consider whether they find the justification acceptable and, as has happened, may even initiate a process to update a guideline.