EMA’s Management Board has re-elected Christa Wirthumer-Hoche as its chair for a three-year mandate. Dr Wirthumer-Hoche is Head of the Austrian Medicines and Medical Devices Agency, a post she has held since October 2013. This is her second and final mandate as chair, as the rules of procedure of the Board foresee a maximum of two terms. More information is available here.
Updates on Brexit
This was the first meeting of the Management Board in EMA’s new temporary premises, the SPARK building in Amsterdam, Sloterdijk. The Board heard that EMA has been operating in Amsterdam since Monday, 11 March and that the first EMA committee meetings have run smoothly, thanks to the close collaboration with the Dutch authorities and the commitment of EMA’s staff.
As the Agency will need several months to rebuild its workforce, EMA will continue to operate under business continuity conditions until at least the end of 2019 to safeguard core activities related to the evaluation and supervision of medicines. This may impact on the implementation of important pieces of legislation such as the medical devices legislation, the veterinary legislation and the General Data Protection Regulation (GDPR). At its next meeting in June 2019 the Board will discuss a list of temporarily suspended or reduced activities which could be gradually restored as a priority.
The Board was updated on the potential impact of Brexit on the supply of centrally authorised products (CAPs) and noted that the number of medicines at risk of shortages continues to decrease because more companies take the necessary steps to ensure that their medicines can remain on the market. Work is still ongoing with national competent authorities to verify availability and identify alternatives at national level.
In February, the Commission published possible exemptions to the rules for batch testing, which may also lower the number of products currently considered as critical and at risk of supply shortages, provided that eligible companies make use of the new available measure and the exemption is granted. The Agency is currently reviewing the requests for exemptions.
Despite the proactive approach by the European medicines regulatory network, there is still a high risk of supply issues with some medicines if the UK were to leave the EU without a withdrawal agreement.
EMA will publish shortly a questions-and-answers document for patients, healthcare professionals and the general public on the preparatory work that EU authorities are doing to prevent medicines shortages due to Brexit.
Medicines for children: achievements and challenges
Dr Dirk Mentzer, chair of EMA’s Paediatric Committee (PDCO) and Head of Pharmacovigilance at the German national agency for vaccine and bio medicinal products (Paul-Ehrlich-Institut), updated the Board on the work of the Committee and the steps taken since publication of the Commission’s ten-year report on the impact of the EU’s paediatric regulation on the development of medicines for children in the EU in November 2017.
“The report shows that although development in children has become an integral part of the overall development of a medicine, there is still a lot that can be done to further improve the situation for young patients,” said Dr Mentzer. “For future discussions on the development, approval and marketing of medicines for the treatment of children, the participation of all stakeholders is essential, including stakeholders not directly involved in the paediatric investigation plan process, such as national competent authorities, health technology assessment bodies and payers.”
Annual report 2018
The Board adopted EMA’s annual report for 2018. The Board acknowledged the challenging circumstances for EMA in 2018. The diversion of EMA’s resources to prepare for Brexit and the relocation to Amsterdam meant that EMA had to temporarily reduce or suspend many initiatives to be able to protect all activities directly related to the evaluation and supervision of medicines as well as core public health activities.
Despite these reservations, 2018 saw many advances regarding new medicines. Altogether, EMA recommended the authorisation of 84 new medicines for human use, including 42 with a new active substance. Many of these new medicines represented significant progress in their therapeutic areas.
In the veterinary area, EMA recommended ten medicines for marketing authorisation. Of these, four had a new active substance and three were vaccines.
Publication of the 2018 report is planned in April 2019.
Update on the development of the Clinical Trials Information System for the EU Clinical Trial Regulation
The Board was updated on the status of the ongoing development of the Clinical Trials Information System (CTIS – formerly the EU clinical trial portal and database). The project plan has been revised to improve delivery and to ensure that stakeholders can give feedback more regularly during the process so that their expectations can be taken into account, whilst enabling the legislation to come into application as early as possible, but retaining the possibility to extend functionalities in the future.
The contract for the delivery of the system has been restructured, so that the code of the safety reporting can be merged with EU clinical trial portal and database system modules, key bug fixing can be carried out and the system can then enter a phase of iterative, agile development as of June 2019. This approach will support the further enhancement of the system, in close interaction with the user community, through the audit and until after the system has gone live and the Clinical Trial Regulation has entered into application.
Further announcements will be made before user acceptance testing commences on the release that will be subject to audit. The Agency and the Member States are fully committed to ensuring the success of this project and its delivery.
