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Topic: Regulatory considerations for rare disease drug development – A global perspective.
Description: There are approximately 7000 rare diseases affecting less than 10% of the world’s population. It became obvious in around 1980 that incentives must be provided to encourage drug manufacturers to invest time and money to develop products that affect a small population in the world. United States was the first country to bring a legislative change, an Orphan Drug Act, following which many countries around the world established regulations for orphan drug products or medicines for rare diseases. In the United states, orphan drug designation can be requested for products for diseases affecting population of less than 200,000. In the EU orphan medicine status can be requested for a life-threatening disease where there is no existing alternative treatment and if the prevalence of the condition is not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development. Japanese regulatory agency considers drugs and devices for orphan designation if they can demonstrate high efficacy and safety for rare and serious diseases affecting 4 in 10,000 people where no alternative treatment exists. In Australia orphan drug status can be requested based on the rarity of disease occurrence (1:10,000). Health Canada proposed a regulatory framework for orphan drug development. This webinar will provide an overview of orphan drug regulations, review process and incentives in the US, EMA, and rest of the world.
Speaker: Sathya Ganesan, PhD, RAC
Regulatory Affairs Manager, PPD
|Date:||Tuesday, April 3, 2018|
|Time:||1:00 p.m. to 2:00 p.m.|