The European Medicines Agency (EMA) has published its Annual Report for 2018, highlighting the successes of the Agency over the last year.
The Report discusses the Agency’s performance in its human medicines role over 2018. It says:
“In 2018, EMA recommended 84 medicines for marketing authorisation. Of these, 42 had a new active substance, i.e. one that had not previously been authorised in the EU.”
The Agency is also proud that this period saw Advanced Therapy Medicinal Products (ATMPs) Kymriah, Yescarta and Luxturna approved. Several other drugs for rare diseases also made their way through EMA assessment.
Alongside this news is a discussion on the impact of Brexit on the EMA, particularly around how the Agency has completed its relocation to Amsterdam from London. EMA hope they have mitigated many of the risks of Brexit through careful planning, and Deputy Executive Director Noel Wathion strikes a cautious tone:
“Brexit is a major obstacle that we did not foresee and it has had a significant impact on the Agency, its staff and the network – and of course on the fact that the Agency has had to relocate to a new country. However, we cannot afford to fail and we will not. Ultimately, we have a responsibility towards patients and users of medicines.”