We author publications presenting our opinions, methodological approaches to health
products development, and our views on environment changes.

Cell Therapy - Current Regulatory Framework,Forum article for April 2003


Cell therapy consists of the prevention or treatment of human diseases by the administration of viable cells which have been selected, cultured, often multiplied, and possibly pharmacologically treated or altered outside the body (ex-vivo). This article will present the wide array of different approaches present today in Europe for the regulation of cell therapy products and envision how cell therapy products could be regulated in the near future.

Progress in the development of Regulations for Orphan Drugs in Europe,Forum article for December 2002


Innovative therapies pose special problems for drug developers and regulators alike. By definition, such therapies tend to leap forward into unregulated or incompletely regulated territory. Orphan drugs often fall into the category of “innovative therapies” and certainly stretch and challenge established regulatory guidelines.

Global challenges facing the biotechnology industry

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

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

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)).