The European Medicines Agency (EMA) is intent on establishing a firmer framework for its work with academia as the agency needs to keep abreast of advances in science and continue to hone its regulations.
Currently, like in the US, academia provides the European drug regulatory system with thousands of experts to ensure new treatments are evaluated and monitored to the highest scientific standards.
And as advances lead to new medicines developed, manufactured, assessed and used in novel ways, particularly with personalized medicines, EMA is interested in pursuing opportunities for greater collaboration to find new ways to approve such treatments through up-to-date methodologies and to monitor their use throughout a drug's lifecycle.
Academia and other public-private partnerships helped to develop about 17% of the 94 products approved between 2010 and 2012, according to EMA.
One of the key priorities of the recently published EU Medicines Agency Network Strategy to 2020 is the need to address unmet medical needs by keeping abreast of advances in science and providing an appropriate regulatory environment.
“Over the next five years the network will need ensure it has the capability to regulate the novel products of the future and to strengthen its capability to adequately assess and monitor these new medicines,” EMA said in its strategy. “Regulatory science, as an approach to how products are developed and regulated will become more prominent and regulators will need to work more closely with the academic community and expert patient community, industry and others to ensure appropriate support is given to the developments in this area.”
EMA also said it will work to build off of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which it created with the help of academics to strengthen its monitoring of the benefit/risk balance of drugs.
Now, EMA is wondering what it can do to better support academia in generating new medicines that meet regulatory standards; how it can channel academia’s advanced knowledge into the regulatory environment; how to assess the awareness among academics of the existing activities and incentives provided by regulators to support medicine development; and how it can refine regulators’ understanding of academia’s needs and expectations and develop a methodology for collaboration.
EMA is inviting academics to answer these questions online by 15 April 2016. The data and contributions collected will be analyzed and the results will be communicated to the respondents, EMA says.
EMA consultation on the proposal of a collaboration framework with Academia