Regulatory affairs - Strategic thinking
On 27 March 2015, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) launched a draft paper for consultation outlining their strategic direction for the next five years. This is the first time that both agencies have aligned themselves under one banner in a coordinated approach and is a significant step in the acknowledgment of a rapidly developing regulatory landscape.
Key areas
The agencies state that the new strategic document will help to strengthen collaboration across the network as well as meet the demands being faced by challenges in public health. In order to deliver on this they have focused on four main themes: Contributing to human health; contributing to animal health and human health in relation to veterinary medicines; optimising the operation of the network; contributing to the global regulatory environment.
In each of these themes the agencies have identified four key objectives to work towards over the five year period.
These areas of focus provide companies both small and large with a golden opportunity to align their regulatory strategies to the proposed changes in the agencies focus in the following ways:
- Human health
The agencies are targeting areas such as product availability and antimicrobial resistance as well as more flexible but robust regulatory pathways to support growing capabilities. This allows companies to help leverage disease areas where time-to-approval is key for patient welfare (such as dementia, for example).
- Veterinary medicines
The agencies are targeting a much more efficient regulatory framework thus allowing greater transparency in the approvals of veterinary medicines, as well as a more robust internal market for movement of approved products across Europe.
- Network optimisation
The agencies are focusing on strengthening global networks, such as those with pricing and reimbursement bodies, thus potentially facilitating quicker access to medicines. They are also focusing on greater collaboration with medical devices and therefore a greater opportunity to help steer regulation in this rapidly developing growth area.
- Global environment
The network will be taking a lead role in the convergence of global standards in close association with WHO. This will include integrated cooperation with emerging markets such as China and India, providing a more harmonized global framework.
Conclusion
The emergence of this draft paper for consultation has helped to bridge the gap between innovation and regulation within a global landscape. It shows that the agencies are keen to be more collaborative and transparent, thus acknowledging the change in the scientific landscape. This paper is a step in the right direction and we look forward to its development and implementation over the next five years. The door has now been opened, so companies should be encouraged to take advantage of the proposed changes to the regulatory landscape and maximise their growth potential.