EMA publishes work plans for infectious diseases and oncology
The European Medicines Agency (EMA) has published work plans for its Infectious Disease Working Party (IDWP) and Oncology Working Party (OMCWP), outlining the actions these groups will undertake over the next three years.The work plans are divided into short-term and long-term goals, along with tactical goals and cover activities from January 2025 to December 2027.
The IDWP and OMCWP are responsible for preparing, reviewing, and updating guidelines and concept papers related to the development of treatments for infectious diseases or oncology, as well as providing training and workshops for assessors.
The short-term goals of the IDWP include drafting a concept paper on toward the eventual update of its guideline on the clinical evaluation of antifungal agents used to treat invasive fungal diseases, developing a guideline for the evaluation of medicinal products aimed at treating influenza, and finalizing the guideline for the clinical evaluation of medicinal products intended to treat hepatitis B virus infection.
The long-term goals are to fulfill the broad objectives associated with the EMA network strategy and to support the Emergency Task Force (ETF) in activities not covered by guidelines, and to contribute to the activities of the Innovation Task Force (ITF) such as assessing scientific advice and protocol assistance, and orphan designation related to infectious disease.
Some of the tactical goals include finalizing the update of the guideline on the clinical evaluation of medicinal products intended for the treatment of hepatitis B virus infection. Additionally, a goal is to complete the concept paper for updating the guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal diseases.
Some activities scheduled to start in 2025 include the development of a guideline for evaluating influenza treatments.
Some of the short-term goals of the ONCWP are to assess the necessity of developing new guidelines or reflection papers in oncology. This will be based on emerging needs identified through EMA scientific advice (SA), protocol assistance (PA), qualification procedures, and discussions from the Committee for Medicinal Products for Human Use (CHMP).
Another aim is to expand the Oncology European Specialised Expert Community (ESEC) through enhanced communication and training activities.
The party's long-term goals are to enhance oncology network capabilities and build expertise. This will be achieved by developing newsletters and training materials, promoting information exchange among assessors, leveraging collaborations with academic and professional societies, and building on the experience gained thus far, as well as published guidance.
A long-term goal is to promote collaborative evidence generation by providing appropriate guidance documents, facilitating information exchange, and contributing to multistakeholder platforms. This initiative aims to optimize oncology drug development.
Some of the tactical goals include finalizing a concept paper on guidelines for the clinical evaluation of anticancer medicinal products, with the aim of releasing it for public consultation in the second quarter of 2025. Another goal is to issue a concept paper on the clinical evaluation of therapeutic radiopharmaceuticals in oncology in the fourth quarter of 2024, followed by the release of draft guidelines in the fourth quarter of 2025.
Infectious disease work plan; Oncology work plan
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