The European Medicines Agency (EMA) has launched a three-month public consultation on its Road Map to 2015.
The Agency is calling on all European and international partners and stakeholders – including patients’ and doctors’ organizations, the pharmaceutical industry and the public – to make their views known on the document – The European Medicines Agency Road Map to 2015: The Agency’s contribution to Science, Medicines, Health – by April 30.
The Road Map specifically identifies the following three priority areas for future action by the Agency:
– addressing public health needs by: stimulating R&D in areas of unmet medical needs or for neglected and rare diseases; facilitating new and innovative approaches to the development of medicines; and implementing effective preparedness plans to deal with public health threats;
– optimising the safe use of medicines by: strengthening the evidence base on benefits and risks following a medicine’s authorisation; applying novel pharmacovigilance methodologies and risk minimisation tools; taking patient experience into account for improved decision-making; and becoming a reference point on information about EMA-evaluated medicines; and
– facilitating access to medicines by: addressing the high attrition rate during the drug development process; improving its benefit/risk assessment model; and improving the quality and scientific and regulatory consistency of the review process.
Discussing this latter priority, the EMA notes that, despite increased research efforts, there is currently “a medicine development productivity gap,” and that this is due both to new development requirements and drugmakers’ “suboptimal management” of the process. It proposes to tackle these issues through a number of initiatives including: continuing efforts to optimise the scientific advice process; strengthening the involvement of stakeholders, particularly academics and patient groups, in drawing up medicines development guidelines; exploring whether the proven benefits of regulators engaging in early-phase development of pediatric medicines could be extended to the area of adult-use medicines; and exploring what incentives could be offered to the industry to make information from failed development projects available to the scientific community.
The EMA is also seeking a new platform for dialogue with the European Commission in order to improve the Agency’s input into the European Union (EU) research agenda for medicines, to complement current initiatives on fostering innovation such as the Innovative Medicines Initiative (IMI).
Improvements are also needed in the area of clinical trials, particularly in relation to the “current disconnection” between trials and EU scientific advice, it says, while the Commission’s impact assessment of proposed changes to the clinical trials legislation has revealed a need to establish an “overarching” regulatory process, covering all stages of medicine development up to licensing.
Finally, the EMA notes that the increasing globalisation of clinical research and manufacturing and its movement to low to middle-income countries needs careful consideration, and its plans here include further development and implementation of its strategy for acceptance of clinical trials conducted in third countries.
