ATMP Group Developments from May to August 2025

Between May and August 2025, the ECA ATMP Interest Group remained actively engaged in discussions surrounding Advanced Therapy Medicinal Products (ATMPs) from a regulatory and scientific perspective. The group maintained its strong multidisciplinary foundation and expanded its educational and collaborative initiatives.

Board Developments
During this period, the composition of the ATMP Interest Group Board remained unchanged. The group currently benefits from a highly diverse and balanced team of experts representing various sectors within the ATMP field, including industry, academia, regulatory bodies and consultancy. This stable composition has enabled consistent and efficient collaboration within ongoing projects and discussions. The next online board meeting is scheduled for November 2025, when the group will continue to align its priorities and review the progress of current initiatives.

Guideline Developments
A key regulatory development during this period was the publication of the EMA Concept Paper in May 2025, which announced the planned revision of EudraLex Volume 4, Part IV. The ATMP Interest Group reviewed the document in detail and submitted formal comments expressing concerns and considerations regarding the proposed integration of Annex 1 into the revised guideline. The release date for the corresponding draft document has not yet been announced.

In addition to this major contribution, the group participated in several other commenting activities on emerging regulatory and pharmacopoeial documents, providing input on the new Ph. Eur., for example. Chapter 5.34 (Additional information on gene therapy medicinal products for human use) Chapter 6. Through these efforts, the group continues to ensure that the practical and scientific perspectives of ATMP developers are represented in European regulatory developments.

Miscellaneous
The months were also marked by several successful events and new initiatives. The “ATMP – short & simple” and “ATMP meets Development” training formats were both delivered successfully and received positive feedback from participants. Building on this momentum, the board finalised the planning of two new event concepts focusing on the supply chain of ATMPs and SoHO with a focus on blood/plasma and cell and gene therapy (CGT), which have now been launched.

Looking ahead, the group is particularly pleased to be collaborating with the Pharmaceutical Microbiology Working Group to present the Pre-Conference Quality Control of mRNA/LNP Products for the first time at PharmaLab 2025 in November in Neuss/Düsseldorf. Additionally, the long-standing ATMP/Cell and Gene Therapy Track on Quality and Safety will once again be part of the PharmaLab programme, continuing the tradition of fostering interdisciplinary dialogue between science, industry and regulation.