The European regulatory system for medicines is based on a network of all national medicines regulatory authorities for both human and veterinary medicines in the EU and European Economic Area, united in the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA). The new 2020 Regulatory Strategy document is a high level strategy explaining what work needs to be taken forward and why. It builds on the EMA roadmap to 2015 and the HMA strategy document 2011-15. It is open for consultation until 30 June 2015. Of their 4 identified themes, ‘Contributing to Human Health’ is the most relevant.
Key themes
- Theme 1: Contributing to human health
- Focus on key public health priorities including availability of medicines and antimicrobial resistance (AMR)
- Review whether there are areas that could benefit from regulatory incentives to support the development of novel products and review how to ensure continuity of supply of good quality appropriately authorized medicines.
- AMR will remain a high priority for the network and the network will facilitate access to the market of new antibiotics, particularly those against multi-drug resistant infections
- Dementia is one area that the network believes could benefit from regulatory initiatives
- Exploring the needs of rare disease patients and coordinate better the existing tools like horizon-scanning exercises for orphan medicinal products carried out by different institutions
- Ensure Timely access to new beneficial and safe medicines for patients
- Ensuring timely access to novel medicines and taking forward the idea of adaptive pathways and strengthening cooperation with the Health Technology Assessment (HTA)/ Pricing and reimbursement bodies and healthcare professionals and patient representatives.
- Support for patient focused innovation and contribute to a vibrant life science sector in Europe
- The network will work to ensure the optimal implementation of the Clinical Trial Regulation, collaborate more on supporting innovation and considering further regulatory incentives for innovation, particularly in certain areas of public health need.
- Strengthen regulatory capability and transparency
- The network will ensure that it has the capability to regulate novel products of the future, develop regulatory science, consider greater use of real world databases and increase transparency about the data that underpin regulatory decisions.
- Theme 2: Contributing to animal health and human health in relation to veterinary medicines
- Theme 3: Optimising the operation of the network
- Theme 4: Contributing to the global regulatory environment
- Assure product supply chain and data integrity
- The network will intensify measures to continue to assure product, supply chain and data integrity within increasingly complex global supply chains.
These priorities will be reflected in the EMA and the HMA’s work for the coming 5 years and serves as a good guide for upcoming initiatives. Early and easy access to treatment remains a core goal for medicine agencies and, in line with the new Commission advisory group on the Safe and Timely Access of Medicines for Patients (STAMP), this strategy foresees novel ways to increase availability and access to medicines including closer collaboration with Health Technology Assessment bodies. Furthermore, AMR is seen as amongst the most pressing health threats, which is common across all bodies, and reflected by ongoing discussions in the European Parliament.
More information is available here.
