EMA, HMA consult on next 5-year network strategy
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) on Monday released their next five-year network strategy aimed at steering the regulators through a “time of rapid charge” for a two-month public consultation.The 46-page European medicines agencies network strategy to 2025 sets out six priorities for the regulatory network in the post-coronavirus era and follows the agencies’ previous network strategy to 2020. (RELATED: EU regulators reveal 'Strategy to 2020', Regulatory Focus 31 March 2015; EMA, HMA Set 10 Priorities for Big Data, Regulatory Focus 20 January 2020).
The six focus areas set out in the strategy include:
- Availability and accessibility of medicines
- Data analytics, digital tools and transformation
- Innovation
- Antimicrobial resistance and other emerging health threats
- Supply chain challenges
- Sustainability of the Network and operational excellence
“The draft strategy details how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats such as the COVID-19 pandemic,” EMA says, noting that the strategy was developed in aligned with the European Commission’s new pharmaceutical strategy. (RELATED: European Commission consults on roadmap to pharmaceutical reforms, Regulatory Focus 2 June 2020).
Stakeholders are asked to complete an online questionnaire to provide feedback to EMA on the strategy by 4 September 2020. EMA says it will consider the feedback it receives in assembling a final draft of the strategy and that it anticipates the strategy will be adopted by its management board and the HMA by the end of 2020.