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EMA and FDA to start monthly transatlantic drug safety teleconferences

By Gareth MacDonald+

20-Feb-2014

EMA and FDA to talk drug safety every month
EMA and FDA to talk drug safety every month

The EMA has confirmed that new monthly drug safety discussions with US counterparts will focus on information exchange rather than policy development.

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced plans to the so called pharmacovigilance cluster this week, explaining that the idea is to hold a monthly teleconference to discuss drug safety issues impact both agencies.

A spokeswoman for the European regulator told in-Pharmatechnologist.com that: “Discussions at the cluster are an opportunity to really understand each other’s thinking in relation to pharmacovigilance.

However,” she continued “the EMA’s and FDA’s respective approaches to pharmacovigilance are guided and determined by the respective legal framework in place in each region.”

The teleconferences will be attended by 5 or 6 EMA staff, depending on the topic, and an equivalent number of FDA employees, plus various members of the Pharmacovigilance Risk Assessment Committee (PRAC) that was established in Europe in 2012 .

The US FDA also confirmed that representatives from Canadian and Japanese regulatory authorities will participate as observers and reiterated that information exchanged at the meeting is covered by confidentiality arrangements between the FDA and the other participants.

Specific discussion topics are yet to be decided, however in general the meeting will be used “to share information and discuss issues related to the safety of medicines, currently being reviewed by EMA and or FDA” according to the EMA spokeswoman. 

Hands across the ocean

The collaboration is one of a number the EMA and FDA has set up in recent years, which include a regular discussion of biosimilars, cancer drugs, orphan medicines and treatment for children. 

More recently the two agencies agreed to collaborate on the inspection of generic pharmaceutical production facilities in an effort to reduce the increasing amount of audit work each is required to conduct.

Like the previous accords the new drug safety cluster is designed reflect the changing dynamics of the drug market according to EMA executive director, Guido Rasi.

Medicines’ regulators are inter-dependent: any action taken in one territory has repercussions on the rest of the world. International cooperation is a key area of work for the agency.”

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