EMA和FDA将“生物仿制药”纳入双边交流议题

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http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/06/news_detail_001282.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

23/06/2011

European Medicines Agency and US Food and Drug Administration set up biosimilar 'cluster' and publish first report on interactions

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new 'cluster' on biosimilar medicines.

Clusters are topic areas of mutual interest for the two agencies, which they have identified as benefiting from the regular exchange of information and collaborative meetings. Biosimilar medicines is the latest addition to the existing list of topics, which already includes medicines to treat cancer, orphan medicines, medicines for children and blood-based products.
The new cluster will allow the two agencies to increase their degree of interaction and will begin with a kick-off meeting to discuss the group's activities. The group will follow this with discussions by teleconference around three times a year.

This is the latest step in the two agencies' ongoing collaboration on regulatory issues under their confidentiality arrangements, which they first signed in 2003. The degree of interaction between the EMA and the FDA has increased significantly since then, to the current stable level of around 55 interactions per month, according to the first report on interactions between the two agencies, published today.

The report, which covers regular and ad-hoc interactions, emphasises the close level of collaboration between the two agencies, including the exchange of staff and regular staff visits, the co-ordination of communication on high-profile issues and the exchange of information on topics of shared interest.
The agencies plan to issue an report on their interactions every year.