The December meeting of EMA’s Management Board was hosted by the Dutch government as the Agency’s interim building is now closed to prepare for the move to the new EMA building in Amsterdam Zuidas in January 2020. The move to the final building opens a new chapter for EMA and will allow the Agency to fully refocus on its mission of protecting public and animal health. However, Executive Director Guido Rasi stressed the challenges that the Agency now faces in reinitiating its activities following three years of relocation and Brexit preparedness planning and postponed investment into business-critical infrastructure. In the meantime, important new demands have been placed on the Agency that will need to be prioritised, such as the implementation of the new legislation for veterinary medicines and the new legislation on medical devices. At the same time, the Agency now has an available workforce of 775 which is significantly less compared to end 2017 when EMA’s relocation plans took shape.
As a consequence, in defining its work programme for 2020 and beyond, EMA will focus on the core activities identified in the last phase of business continuity as a baseline and will prioritise additional tasks depending on available resources. The Agency will continue to monitor staff levels and review whether additional activities can be relaunched in June 2020.
To help the Agency make best use of available resources and be best prepared for future challenges, EMA is currently conducting an in-depth review of its organisation. This future-proofing exercise will help EMA to strengthen its ability to perform important new activities together with the European regulatory network and to tackle important challenges ahead such as big data, digitalisation and new scientific methods and technologies.
EMA budget for 2020
The Board adopted EMA’s budget for 2020 and a preliminary draft programme and budget for 2021. EMA’s budget and work programme for 2020 will be published on the EMA website in Q1 2020. The 2020 budget is set at EUR 358 million, a 3.3% increase on 2019.
EU cooperation on medicines’ availability
The Board heard an update on the outcome of the first phase of a pilot on the EU SPOC (single point of contact) network for cooperation on availability of human and veterinary medicines. The SPOC system was set up in 2019, as a deliverable of the joint HMA-EMA taskforce on the availability of authorised medicines, to improve information-sharing on important shortages of medicines between Member States, EMA and the European Commission. It also allows Member States to share information on medicines that could be used as an alternative and are available in other Member States. This could help prevent and manage shortages.
The first phase of the pilot ran from April to August 2019 to test the functioning and usefulness of the information exchange of the SPOCs. During this phase, 52 notifications of shortages were circulated within the SPOC network. 24 Member States made use of the SPOC system for sharing information on shortages during phase one of the pilot.
A second phase is foreseen for 2020 during which additional responsibilities of the SPOCs will be tested which are expected to improve the handling of shortages. Criteria for identifying cases deserving EU-wide coordinated action will be tested together with criteria for network alerts of upcoming public communications by different Member States that could have a high impact on patients. Before moving to the second phase, however, it is important to ensure that necessary resources can continue to be made available by EMA and the national authorities in the Member States.
More information will be published once the second phase of the pilot is completed.
Update on the EU IT systems required by the Clinical Trial Regulation
The Board endorsed the outcome of the ‘audit readiness assessment’ and endorsed the proposal to commence the audit in December 2020. The assessment was carried out on the Clinical Trial Information System (CTIS) by the nominated product owners representing EU Member State authorities, the European Commission and sponsors as well as EMA and the IT supplier. While the system is already extensively developed, this assessment was conducted to identify critical items that still need to be fixed/developed for audit. The outcome includes an updated plan that outlines the items needed for audit to commence by end of December 2020.
The Board also noted the good progress in developing the CTIS by the supplier. The latest release of the system was validated in December 2019 by the nominated product owners. This release enhances CTIS functionalities concerning the process for the evaluation of clinical trial applications, data submission and view of data, management of user access, users’ oversight of activities and data transparency. These enhancements relate mainly to the authority and sponsor workspaces in the system.
In the first few months of 2020, product owners will work with EMA and the IT supplier to perform the analysis and design of the items that have been prioritised as still needing to be fixed/developed before the audit can begin. The approach will be carried out in a way that ensures efficient delivery.
Handling new information on nitrosamine presence in medicines
The Board was updated on EMA’s ongoing review into nitrosamine presence in medicines and on the EU network’s approach to handling emerging new information. As part of the review, in September 2019, EU regulatory authorities requested companies to assess the risk that their manufactured products contain nitrosamines and test products identified.
The European medicines regulatory network has agreed to reinforce the use of interim limits for the evaluation of cases where nitrosamines are identified, in line with the report issued by the Agency on the sartan review. This initiative is being taken in order to streamline the processes with which new information on nitrosamine presence in medicines is handled, whilst the scientific review by the CHMP under the Article 5(3) procedure is progressing. Should the interim limits be exceeded this will be handled through the EU network’s existing rapid alert systems. The Board welcomes the cooperation on the issue that is already ongoing at European level and encourages continued discussion with regulators from outside the EU.
Other meeting highlights
Mandatory use of international standard for reporting side effects to improve safety of medicines
The Board agreed to the mandatory use of the ISO ICSR format based on the ICH E2B(R3) modalities for the reporting of suspected side effects of medicines in individual case safety reports (ICSRs). The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects reported with medicines authorised in the European Economic Area (EEA). Further information and targeted communication to stakeholders is planned for January 2020.
HMA-EMA Joint Big Data Taskforce Report
The Board adopted the second report of the HMA-EMA Joint Big Data Taskforce. Further information and publication of the report is planned for January 2020.
Key principles and roadmap on electronic product information (ePI)
The Board endorsed the EMA–HMA–EC key principles for electronic product information (ePI) together with the roadmap. More information and relevant documents will be published in Q1 2020.