To celebrate 20 years since its opening, the European Medicines Agency (EMA) organized a one-day meeting this week. Called “Science, Medicines, Health: Patients at the heart of future innovation”, the invitation-only event in London focused on the EMA’s future role
To celebrate 20 years since its opening, the European Medicines Agency (EMA) organized a one-day meeting this week. Called “Science, Medicines, Health: Patients at the heart of future innovation”, the invitation-only event in London focused on the EMA’s future role.
Over the past 20 years, EMA has recommended the authorization of 975 human medicines and 188 veterinary medicines. Its success is based on cooperation within the European medicines regulatory network and a partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA, it states.
According to a statement, “Looking back at the past two decades, the Agency is proud of its successes, impressive growth and achievements. Yet, in addition to celebrating past successes, the Agency has its eyes firmly set in the challenges of the future. Cognizant of its pivotal role at the crossroads of life science research and development, patient care, public health policy and law, the Agency will use this event to explore with a range of stakeholders how best to deliver its role in the future.”
Seven scientific committees and more than 30 working parties provide scientific guidance for the regulation of medicines by drawing on a pool of several thousand European experts, and this has encouraged the exchange of knowledge, ideas and best practices between European experts striving for the highest standards in medicines regulation, noted the Agency.
In addition, EMA has produced an anniversary book about the progress in regulatory science and changes in medicines regulation in the last 20 years. The 66-page book describes the Agency's role in addressing these drivers for change. To access it online, click here.
This year also marks the 50th anniversary of the introduction of the first EU legislation on human medicines. On 26 January 1965, the Council Directive 65/65 on the approximation of the law relating to medicinal products was adopted.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.