A comparative assessment may be initiated by an application for the authorisation of a new candidate product, for the renewal of an existing authorisation, or for the amendment of an authorisation for new uses of a candidate product.
In the evaluation of similarity in the context of orphan drug evaluation, the CHMP needs to decide whether or not an active compound for which a new medicine, or an extension of an existing marketing authorisation (change of indication or line extension), is being sought is similar to an existing orphan drug that has already been authorised.
The PUMA will utilise existing marketing authorisation procedures but is specifically for medicinal products developed exclusively for use in children.
The final denouement has just played out in the French Parliament with an announcement last week which makes specific reference to resistance in the South that all existing shale gas permits and authorisations have been annulled.
This throws into doubt the adequacy of the existing system for approval and authorisation by a designated person within the police force or public authority which seeks communications data.
We propose a platform-independent system that uses proxy applications to provide both secure transport and authorisation services transparently to existing Internet applications.
In conclusion, we have found that experience in the drug development process and development of already existing (small) molecules are associated with market authorisation of orphan drug designations.
Although not significant, it shows that the odds of authorisation for products based on existing synthetic entities may be about four times higher compared to biotechnological products.
This is a systematic process to identify new medicines or new indications of existing medicines that are expected to receive marketing authorisation from the Regulatory Authority in the near future and to estimate their potential impact on patient care [ 16].
Assume that a new molecule M is being submitted for orphan drug authorisation, and that there is already an existing drug D for this indication.
