EMA's 25th Anniversary

In 2020 EMA celebrated its 25th anniversary. Since the Agency’s creation on 26 January 1995, the environment in which EMA operates has undergone fundamental scientific, technological, legislative and social changes. But its mission has remained: bringing the best experts from around the EU together to create an efficient and robust system for the evaluation and supervision of human and veterinary medicines that serves citizens throughout the EU. This has allowed EMA to remain agile and adapt to continuous extensions of its legal mandate and to deliver for public and animal health in Europe.
 

25 years of advancing public and animal health

To mark its 25th anniversary, EMA organised a series of events in 2020 together with its stakeholders. Due to the pandemic restrictions, not all planned events could take place. The meetings and conferences that had not to be cancelled were held virtually, underlining EMA’s successful transition into an online-based meeting environment. 

20 years of orphan medicines regulation

December 2020 marked the 20th anniversary of the Orphan Regulation. The EU’s orphan designation programme offers incentives to encourage the development of medicines that otherwise would not be developed to help diagnose and treat patients with rare diseases. These are often debilitating and life-threatening diseases that place a huge burden on the patients, their families and carers, and represent an enormous challenge for countries’ public health systems.

Since the EU orphan regulation entered into force in 2000, EMA has given orphan status to over 2,300 medicines. By the end of 2020, 192 medicines with orphan status received a marketing authorisation. The European Commission completed an evaluation of the Regulation in August 2020. It has been an EU success story and it is delivering in public health terms. It has helped many, but many disease areas have still not attracted sufficient attention and more dedicated research is needed to help patients to access new or better treatments. The findings from this evaluation are being considered as part of the recently launched Pharmaceutical Strategy for Europe.

On 30 November 2020, EMA held a workshop with academia, companies, patients and healthcare professionals. The aim was to review and raise awareness of the range of currently available development support tools and encourage early and efficient interactions with the regulators. A meeting report outlines the key findings.

With the establishment of the Committee for Orphan Medicinal Products (COMP) in 2000, EMA opened its doors to patients and healthcare professionals and their contributions. Today, representatives of patients, healthcare professionals and civil society take part in most of EMA's scientific committees as full members, adding their unique perspective and experiences to the debate. They play an increasingly important role in the assessment of the risks and benefits of medicines.

15 years of SME regulation

The 15th anniversary of the implementation of the SME regulation was another policy milestone in 2020. EMA held a virtual round-table meeting with stakeholders on 27 November 2020 to mark the introduction of this successful initiative. The objectives of the meeting were to:

• provide an update on EU support for small and medium-sized enterprises (SMEs);
• highlight the achievements of EMA’s SME initiative;
• present the results of an SME survey launched by the Agency in 2020;
• exchange views on achievements, challenges and future opportunities to support SMEs and innovation in the pharmaceutical sector.

Representatives of the European Commission, the European Investment Bank (EIB), the EU Agencies Network, industry organisations representing SMEs and service providers in the human, veterinary and med-tech sectors participated in the round-table meeting. The outcomes of the discussion are summarised in a meeting report.