Important Classification Committee Update: Major Restructuring of ATC L-Class Impacting Oncology and Immunology

Important Classification Committee Update: Major Restructuring of ATC L-Class Impacting Oncology and Immunology

The EPHMRA/Intellus ATC Classification Committee is embarking on a pivotal reorganization of the L-class within the Anatomical Classification (ATC) system. This significant change aims to better distinguish antineoplastic (oncology) therapies from immunological products, creating a clearer and more adaptable framework for emerging innovations in both therapeutic areas.

Addressing Current Challenges
Currently, oncology drugs and immunological products are grouped under the same ATC1 level (L-class). While convenient in the past, this classification has become increasingly restrictive given the rapid development of novel therapies, particularly monoclonal antibodies (L1G) and protein kinase inhibitors (L1H). This grouping limits the availability of subcategories, making the classification less able to respond to market evolution.

The Proposed Change
The committee’s proposal introduces a new, dedicated ATC1 F-class for immunological products, allowing oncology drugs to exclusively occupy the restructured L-class. Antineoplastic subclasses within the L-class will be promoted to higher levels, such as L5 for alkylating agents and L10 for monoclonal antibody antineoplastics, among others. Immunology-related products will transition to new classifications (F1 for immunostimulants and F2 for immunosuppressants) to ensure separation from oncology drugs. 
This streamlined approach will enhance clarity in drug classification, separate oncology and immunology, and future-proof the ATC system to accommodate emerging therapies.

EPHMRA Classification Committee – Oncology/Immunology Proposed Developments
Currently both oncology and immunological products are classified within the same ATC1.
Within oncology, there are limited free sub-levels available for expansion to reflect new therapies. Especially in the MAb and PKI classes, L1G and L1H respectively.

The proposal creates a new ATC1 for immunological products and therefore separates them from oncology products.
This allows the promotion of existing L1 antineoplastic ATC3 classes to ATC2 level, providing scope for new class creation in line with market developments. 
L2 Cytostatic Hormone Therapy classes would remain unchanged. 

 
Benefits of the Change
The restructuring of the L-class offers multiple benefits:
• Clarity: Distinct classifications for oncology and immunology products.
• Adaptability: The updated framework can better accommodate market changes and new therapeutic innovations.
• Future-Proofing: The system will be positioned to manage therapies yet to be developed, ensuring long-term relevance.

Implementation Timeline
Voting on the restructuring proposal is scheduled for May/June 2026, with implementation planned for January 2027. This timeline provides ample opportunity for stakeholders to provide feedback and prepare for the transition.

Stakeholder Engagement and Support
To ensure a smooth transition, the ATC Classification Committee is encouraging feedback from industry professionals and organizations. Oncology and immunology teams are urged to review the proposed changes and align accordingly. Comprehensive materials and resources will be available on the EPHMRA and Intellus websites.
Additionally, the Committee will host a webinar to discuss the proposed restructuring in detail, answer questions, and provide further guidance. This event will serve as an opportunity to familiarize stakeholders with the proposed change and answer any questions.

Get Involved

1. Look out for the upcoming webinar to explore the changes and their implications further. 
2  Alert your oncology and immunology colleagues of this proposal.
3.  Share you questions and feedback by contacting the Classification Committee chair, Anthony Palkovic
4.  And finally, vote on the proposal in May/June 2026.  Intellus member companies each get one vote annually on all proposals.

Together, we can ensure the ATC Classification remains a robust and effective tool for classifying therapies in the evolving healthcare landscape.