The work plan of the Oncology working party 2025 to 2027 has been published

The European Medicines Agency's (EMA) Oncology Working Party (ONCWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) in order to carry out specific tasks related to oncology which include the following aspects:

• Preparing, reviewing and updating guidelines and concept papers on working party related matters;
• European and international co-operation relating to working party activities;
• Liaising with interested parties, such as industry, patient organisations and healthcare professional organisations;
• Providing trainings and workshops to assessors;
• Providing product related support upon request from EMA Committees and the Scientific Advice Working Party.

The Oncology working party has just published its consolidated 3 years work plan until December 2027 which includes short term as well as long-term goals.

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).
 
Therefore, one of the tactical goals include the finalising of the concept paper for the clinical evaluation of anticancer medicinal products, with the aim of releasing it for public consultation in the second quarter of 2025. This will be to prepare for the 7th revision of the guideline on the clinical evaluation of anticancer medicinal products and Appendix 1, EMA/CHMP/205/95 Rev.6.

Another goal is to issue the release of a draft guideline on the clinical evaluation of therapeutic radiopharmaceuticals in oncology in the fourth quarter of 2025 following the release of its concept paper in the fourth quarter of 2024. Radiopharmaceuticals are a special type of medicinal products as they are regulated by both the pharmaceutical legislation (2001/83/EC) and the radiation protection legislation (Directive 2013/59/Euratom). A radiopharmaceutical is defined as any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes). Radiopharmaceuticals can be further divided into those intended for diagnostic use, and those with therapeutic indications. The scope of the guideline is to provide specific guidance on how the key concepts from the two areas of legislation should be applied to the clinical development of therapeutic radiopharmaceuticals for marketing authorisation application.

The Oncology working part will also contribute to the reflection paper on the patient experience data in clinical trials and the reflection paper on Cardiovascular Safety in Oncology in 2025.

An important aspect of the oncology working party is Oncology European Specialised Expert Community (ESEC) which has been set up since March 2022. In 2025, it is planned to further expand the Oncology European Specialised Expert Community (ESEC) through enhanced communication and training activities by the involvement and participation of representatives, experts from Health Technology Assessment bodies.

The party's long-term goals are to enhance oncology network capabilities and build expertise. This is 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 optimise oncology drug development. To that extent, the Oncology working party support the activities of the Cancer Medicines Forum.
 
This article is authored by Dr. Pierre Demolis, chair of the oncology working party and vice chair of the scientific advice working party at EMA.