EMA launches rolling review process for Ebola vaccine makers

By Gareth Macdonald contact

- Last updated on GMT

EMA launches rolling Ebola vaccine review plan
EMA launches rolling Ebola vaccine review plan

Related tags: Influenza

Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.    

The Agency said the process was similar to the approach used to speed up the assessment of vaccines in 2009 during the influenza pandemic.

Under the system, Ebola vaccine developers can either seek European Union marketing authorisation or apply for clearance under the so-called Article-58 procedure, which allows the CHMP and WHO to assess products intended for use outside Europe.

The EMA has also set up a panel of experts capable of assessing incoming data and quickly providing developers with scientific opinions.

The London, UK-based Agency has also begun reviewing information of Ebola treatments that are under development to support health authority decision making.

An EMA spokeswoman told in-Pharmatechnologist.com the organisation is “in close contact with a number of developers of treatments and vaccines and is discussing the scientific and procedural aspects with them. However, rapid scientific advice is confidential​.”

She added that: “The EMA is committed to turning an assessment around as quickly as possible, but the timeframe of the review will also depend on the quality of the data receiv​ed” going on to say “the concept of rolling reviews was applied during the assessment of pandemic influenza vaccines and resulted in the approval of several vaccines​.”

Vaccine reviews reviewed

The EMA began reviewing its vaccine approval processes in 2011 after efforts to accelerate the development of pandemic influenza vaccines a few years earlier exposed bottlenecks.

Then the focus was primarily on speeding up the assessment of vaccine potency, as demonstrated in a concept paper issued at the time​ and revised draft guidance published​ for consultation this August.

In contrast, the new process being touted for Ebola vaccines is about accelerating review and balancing safety concerns with public health need according to Tomas Salmonson, Chair of the Agency’s Committee for Medicinal Products for Human Use (CHMP). 

Companies are expected to put efforts into demonstrating that vaccines and treatments against Ebola actually work and are acceptably safe and of high quality, because we need to be reassured that the benefits of these medicines outweigh their risks.

However, in the current emergency situation we accept that the benefit-risk balance is determined largely by the public health need.”

The EMA’s announcement of the rolling review process comes a day after EC President-elect Jean-Claude Juncker confirmed he had abandoned plans​ to hand oversight of the EMA – as part of the overall pharmaceutical package - to DG Enterprise. 

Related topics: Regulatory & Safety, Regulations

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