Key activities and events in 2024
Key activities and events in 2024
January 2024
Major update of the SME user guide
EMA has released a major revision of its user guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector.
© Talia Mdlungu/peopleimages.com | stock.adobe.com
© AnnaStills | stock.adobe.com
Launch of the Antimicrobial Sales and Use (ASU) platform
EMA has launched the ASU platform to support the collection of data by Member States on the sales and use of antimicrobials in animals.
© Gorodenkoff | stock.adobe.com
One year left for clinical trials' transition to the Clinical Trials Information System (CTIS)
All ongoing clinical trials in the EU must be transitioned to CTIS by 31 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.
February 2024
© Andrii Yalanskyi | stock.adobe.com
Progress on pilot for academic and non-profit developers of ATMPs
Following the launch in September 2022, EMA has accepted three academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) into a pilot scheme, in which they benefit from enhanced support from the Agency.
© Lomb | stock.adobe.com
Launch of catalogues of real-world data sources and studies
EMA and the Heads of Medicines Agencies (HMA) have launched two digital catalogues: one for real-world data (RWD) and one for RWD studies.
© Oleksandr | stock.adobe.com
Multi-agency report highlights importance of reducing antibiotic use
Taking a One Health approach, which recognises the connection between the health of people and animals, the report presents data primarily collected between 2019 and 2021 on antibiotic consumption and antimicrobial resistance in Europe. Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.
March 2024
© Felix/peopleimages.com | stock.adobe.com
© kasto| stock.adobe.com
April 2024
© Trodler | Dreamstime.com
ICMRA and WHO report on COVID-19 vaccine strain updates
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO publish a report highlighting the outcomes of their discussions on key regulatory considerations and data requirements related to updated COVID-19 vaccine composition.
© John6863373 | Dreamstime.com
New recommendations to strengthen supply chains of critical medicines
EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.
© Oleksii | stock.adobe.com
Confidentiality arrangement between the EU and the Republic of Korea
EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a working arrangement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for the exchange of confidential information on medical and medicinal products.
© Siarhei Yurchanka | stock.adobe.com
ETF recommends updating COVID-19 vaccines to target new JN.1 variant
EMA’s Emergency Task Force has recommended updating COVID-19 vaccines to target the JN.1 variant for the 2024/2025 vaccination campaign.
May 2024
One Health: a joint framework for action published by five EU agencies
The European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and EMA have published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the EU.
© butenkow | stock.adobe.com
June 2024
© Felix/peopleimages.com | stock.adobe.com
© Gorodenkoff | stock.adobe.com
Improved access to clinical trial information in the EU
EMA announces the launch of the updated Clinical Trials Information System, enhancing early access to clinical trial data for patients, healthcare professionals and stakeholders, in line with revised transparency rules.
© stokkete| stock.adobe.com
EU actions to tackle shortages of GLP-1 receptor agonists
The Medicines Shortages Steering Group (MSSG) has issued recommendations, including manufacturing capacity increases, supply chain monitoring, and prioritisation guidelines, to address shortages of GLP-1 receptor agonists.
Press briefing on EU actions to tackle shortages of GLP-1 receptor agonists
EMA has organised a press briefing to discuss EU actions to tackle shortages of GLP-1 receptor agonists indicated for the treatment of diabetes and in some cases for weight management in patients with obesity or weight-related conditions.
July 2024
© AS Photo Family | stock.adobe.com
EMA supports pilots for joint African continental assessment and inspection procedures
EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to support a pilot to test procedures for the joint continental evaluation and inspections of medicines in Africa.
August 2024
September 2024
© Farknot Architect | stock.adobe.com
Harnessing AI in medicines regulation: use of large language models
EMA and the HMA have published high-level principles and recommendations for all staff across the EMRN using large language models (LLMs) in their work.
October 2024
© dottedyeti | stock.adobe.com
Fostering regulatory collaboration to improve access to mpox medicines
International regulators have published a report highlighting their considerations on the development, clinical trials and availability of vaccines and therapeutics for mpox. It presents the outcomes of a workshop that was organised by EMA under the umbrella of ICMRA.
© Regien Paassen | Dreamstime.com
Seizing opportunities in a changing medicines landscape
EMA and the HMA have published their draft joint EU network strategy to 2028 for an eight-week public consultation.
© Tierney | stock.adobe.com
Handling of competing interests: revised rules for committee members and experts
EMA has launched a public consultation on its draft revised policy on handling competing interests of scientific committee members and experts.
November 2024
© Юлия Завалишина | stock.adobe.com
First veterinary vaccine platform certification
EMA’s Committee for Veterinary Medicinal Products (CVMP) has issued the first certificate for a veterinary vaccine platform technology master file (vPTMF), which will support and accelerate the development and authorisation of new veterinary vaccines in the EU.
7th Veterinary International Conference on Harmonization (VICH) conference
On 13 and 14 November, EMA co-hosted the 7th VICH public conference in Amsterdam, under the theme ‘VICH and a new era’, bringing together regulators and industry leaders to discuss global challenges and strategies for enhancing access to veterinary medicines. Key discussions focused on regulatory convergence, international collaboration, and streamlining registration processes to address rising global demand and challenges.
Call to action against the silent pandemic of antimicrobial resistance
To mark European Antibiotic Awareness Day (EAAD) in 2024, EMA has published an infosheet emphasising the urgent need to tackle antimicrobial resistance.
Global regulators commit to playing their part in tackling AMR as a priority
EMA endorses a joint ICMRA statement, which reiterates that preserving the effectiveness of antimicrobials is a top priority globally for the protection of public health and that regulators have an important role to play.
© Westend61 | stock.adobe.com
December 2024
EMA communication activities: 2024 survey results
EMA has published a report highlighting the results of its fifth communication perception survey, which was conducted between May and June 2024.
© pikselstock | stock.adobe.com
Successful pilot paves the way for implementation of ePI
EMA has published a report of a pilot exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures.
End-of-year message from EMA’s Executive Director
Emer Cooke looks back at 2024 and gives insights into the year ahead.
© KanitChurem | stock.adobe.com
A common EU approach to data transparency in medicine regulation
EMA and the HMA have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines.