10 Years of EU Orphan Drug Regulation

It is 10 years since orphan drug regulation was implemented in Europe and the European Medicines Agency (EMA) is marking the anniversary with various conferences and workshops during April and May.

In April 2000, Regulation (EC) No 141/2000 of the European Parliament and the Council on Orphan Medicinal Products came into effect. Since then, over 700 products have received orphan designation to treat rare disorders.

The regulation established the criteria for orphan designation in the EU and delineated the incentives, including market exclusivity, protocol assistance, and access to the centralised procedure for marketing authorisation. The regulation was also developed to encourage the research, development and marketing of medicines to treat, diagnose or prevent rare diseases.

Two workshops and a conference are scheduled to take place at EMA headquarters in London. The first workshop, on nanomedicines, is scheduled for April 26-27, and the second, on May 10, will focus on stem cell-based therapies.

Then on May 3-4 there will be a conference, entitled 10 Years of the Orphan Regulation in Europe, featuring plenary sessions, discussions and three parallel workshops on the development of products for rare diseases, research for rare diseases and patients’ views on the Regulation.

Further details are available from the EMA.

We will keep you up-to-date if we hear of any interesting developments.

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