To Promote Public Health and Free Circulation of Medicines

The European System offers two routes for granting authorizations. A company can or must, depending on the type of product, seek centralized approval, which means an authorization valid for the whole EU. The centralized procedure is compulsory for biotechnology products and optional for innovative conventional products. In this case the application is dealt with administratively by the EMEA. Independent evaluations are conducted by two selected members of the European scientific committee (named CPMP, Committee for Proprietary Medicinal Products). Multidisciplinary teams, coordinated by the selected members, perform those evaluations and discuss their conclusions with the other members. The European Commission makes final decisions after the CPMP has expressed an opinion following its scientific debate.

For innovative conventional products a company can instead choose the route based on mutual recognition of national decisions. The European System affords many advantages. New medicines come to market faster, which of course benefits patients and industry. Also, by utilizing the collective competence of several national drug authorities, the quality and objectivity of evaluations can be improved, duplication of work is avoided, and harmonized opinions and labeling throughout the EU becomes available.

An important part of this European-oriented work also revolves around developing new standards and requirements in the face of rapid scientific discoveries and development of new medicines. The intended end result is to promote public health and free circulation of medicines [20].

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