2. Legislative documents governing medicines regulation


1. Legislative documents governing medicines regulation

1.3. Other types of documents

Other types of documents have been produced in the past, for example, “Position Paper” or “Points to consider”. These documents expressed the view of the EMA Scientific Committees and provide advice on:

• A selected area of medicinal product development where limited experience is available and knowledge is evolving fast, requiring easy updates and flexibility of the document;

• Interpretation of guidelines or of technical requirements in the legislation;

• Further elaboration of specific issues addressed in guidelines, for incorporation into the guideline upon its next revision.

In substance, the documents referred to above (historical documents) also provide some guidance, but instead of the former terminology, the unique term “guidelines” is used and any distinction with respect to limited experience and/or the need for ongoing revision will be clearly outlined within the scope of the respective guideline.