EMA and FDA report on collaborative efforts

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EMA and FDA report on collaborative efforts

INICIO/Políticas y legislación | Posted 16/05/2014 0 Post your comment

Key initiatives being undertaken between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) were discussed at a bilateral meeting which took place in London, UK, from 31 March to 1 April 2014.

Similar meetings of EMA and FDA take place every 18 months, presenting an opportunity to review the collaborative efforts that are taking place between the two agencies.

At this meeting, the agencies reported on the work that has been taking place as part of the biosimilars cluster and the pharmacovigilance cluster. Clusters are topic areas of mutual interest that the two agencies have identified as benefiting from the regular exchange of information and collaborative meetings.

Biosimilars
The EMA–FDA biosimilars cluster was set up in June 2011 and Health Canada has also recently become involved in this cluster. EMA and FDA reconfirmed their plans to support and facilitate the global development of biosimilars. They confirmed that emerging guidance in both regions will allow the use of a reference product sourced from the other region when supported by adequate scientific justification, thus facilitating the use of a common clinical data package that may address the requirements of both regions.

Pharmacovigilance
The EMA–FDA pharmacovigilance cluster was set up in 2013 and was reported as being a success, bringing added value in particular in the areas of information exchange and scientific, procedural and communication planning discussions. Following the success of an EMA/FDA signal exchange on vaccines initiated in January 2013, both sides expressed a desire to continue this activity.

Other topics discussed included drug supply chain challenges, the creation of an EU–US Identification of Medicinal Products (IDMP) task force, veterinary topics such as promotion of the uptake of parallel scientific advice by the animal health industry and paediatric medicines.

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Source: EMA, FDA