On 6 July 2020, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published their 46 page joint strategy for the next five years that is released for a two-month public consultation.
The joint strategy describes the role of the European Medicines Agencies’ network regarding the continuous supply of safe and effective medicines in light of challenges caused by developments in science, medicine, digitalisation, globalisation and emerging health threats such as the COVID-19 pandemic.
CM&S is at the centre of this draft joint strategy as EMA and HMA both acknowledge the value of computer simulation throughout the lifecycle of medicines, for regulatory submissions and for the representation of special populations. These benefits are perceived as enablers when it comes to supporting policymakers and stakeholders with decision-making on investments.
The draft joint initiative also recognises the need for increased uptake of CM&S but stresses the need for consensus on standards including their acceptability for regulatory, HTA and payers’ decision making.
The goals and recommendations outlined in the strategy, once finalised, will inform the work of the EMA and the national competent authorities for the next five years.
Stakeholders are invited to submit their feedback until 4 September through an online questionnaire, which provides an opportunity to share input on the three aforementioned key areas.