Descripció del projecte
Medicines’ regulation varies between the different world areas. However, it is clear that there are some specific Agencies which lead the way in global regulation. Most of the emerging countries follow the guidelines stipulated by some reference Regulatory Authorities, adapting their rules to them.
From a business perspective, the emerging or RoW (Rest of the World) countries are relevant because of the potential they hold for the future of the pharmaceutical industry due to their rapid economic and political development. To internationalize new medicinal products, the pharmaceutical companies must know the registration and maintenance requirements that are demanded by the different National Authorities. For that reason, it is considered essential to map the influences that the main Agencies may have over RoW medicines’ regulation.
The primary objective of this project is to elucidate how the emerging countries are influenced by the medicines’ regulation of other Authorities, considered as reference on regulatory matters. Analyzing the current state-of-the-art of these regions, we will stablish the dominant trends, the interconnections between different Agencies and the medicines’ registration and maintenance difficulty level.
In order to achieve the foreseen objectives, local and international databases will be reviewed and a contact network with National Authorities will be established.
The final purpose is to create a world-map where the main world areas will be clustered into different regions classified by registration procedures difficulty level, to identify harmonization or interconnection relationships between Regulatory Authorities and to provide a comprehensive approach to carry out internationalization procedures.
