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Biomedical subjects

Vittorio Bertele

Publications and source records attributed to Vittorio Bertele.

5 recordsLinked to original sources
PubMed2006

Orphan drug development is progressing too slowly.

AIMS: To assess the methodological quality of OMP dossiers and to discuss possible reasons for the small number of products licensed. METHODS: Information about orphan drug designation and approval was obtained from the website of the European Commission-Enterprise and Industry DG and from the European Public Assessment Reports. RESULTS: Out of 255 OMP designations, only 18 were approved (7.1%). Their dossiers often showed methodological limitations such as inappropriate clinical design, lack of active comparator where available and use of surrogate end-points. CONCLUSIONS: The paucity of European incentives for manufacturers and the poor documentation underpinning the applications may have limited the number of new OMP. The over 5000 rare diseases awaiting therapy are an important public health issue.

Animals↗
PubMed2003

European regulatory policies on medicines and public health needs.

The establishment of the EMEA has been a revolutionary step in the European pharmaceutical system. The 15 Member States of the European Union now share a common system for the evaluation of new medicinal products entering the European market. The decisions taken apply to the whole EU, with important implications for both industry and patients who may benefit from new therapies. The main immediate consequences of this system are: i) the time and effort saved by Member States in the evaluation of new drug applications; ii) more consistent and quicker availability of medicines in EU countries; iii) the establishment of a homogeneous regulatory policy throughout the EU. Public health has been presented as the fundamental concern of the EMEA, the mission statement of which is 'to promote the protection of human health ... and of consumers of medicinal products'. However, we note that there are some inconsistencies with this objective and the current system, such as those regarding drug trial requirements and the institutional location and financing of the EMEA. In this paper, some aspects of the new system are reviewed and consideration given as to how they relate to public health needs. Proposals are made for debate alternatives and improvements to the present system that would better respond to patients' health needs.

Drug Therapy↗