Global challenges facing the biotechnology industry

2002
Current Drug Discovery

Biotechnology has the potential to provide solutions to a number of the world's problems, but must develop globally harmonized procedures and regulations, while still acknowledging and embracing regional issues and differences. Emmanuelle Voisin reports from the recent BIO 2002 in Toronto on the challenges and hurdles faced by this fascinating, yet incredibly demanding global industry.

Orphan Drug Regulation in Europe-Fall 2002

2002
Emmanuelle Voisin

European Member States have decided that they cannot accept that certain individuals be denied the benefits of medical progress because these individuals suffer from a disease that affects only a small fraction of the population. It is therefore their role to facilitate access to medicinal products for these patients, provided that these products are as safe and effective as any other medicinal product, and meet the same quality standards.

Orphan Drug Regulation in Europe - Fall 2001

2001
Emmanuelle Voisin

Rare diseases are referred to as “orphan diseases”, and the products intended to treat them as “orphan medicinal products”. In addition to rare diseases, orphan diseases include those for which developing new therapeutic tools is not profitable. Following the international examples of the United States, Australia and Japan, Europe adopted its “Orphan Regulation” on December 16, 1999 (European Commission Regulations EC No. 141/2000 (1) and EC No. 847/2000 (2)).

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