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ATMP Group Developments from January to April 2025

Find out what the ECA ATMP Group was working on and accomplished in the first four months of 2025 - in the latest report.

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FDA Initiates Transition to Non-Animal Testing Methods for Monoclonal Antibodies

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a significant policy shift aimed at reducing and potentially eliminating the requirement for animal testing in the development of monoclonal antibodies and other drugs. This initiative seeks to enhance drug safety, accelerate the evaluation process, and reduce research and development costs by incorporating human-relevant testing methods.

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EMA Proposes Revisions to GMP Guideline for ATMPs

On May 8, 2025, the European Medicines Agency (EMA) released a concept paper proposing revisions to Part IV of the EU Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). This initiative aims to align ATMP-specific GMP requirements with recent updates in sterile manufacturing and to incorporate advancements in technology and quality management systems.

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Microbiology - EDQM asks for Comments on the new or revised Chapters

Chapters with microbiological relevance are currently being published or revised in a whole series of pharmacopoeias. Chapters on rapid methods, pyrogenicity and endotoxin testing are also currently published for comment in the European Pharmacopoeia.

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Become a Speaker at PharmaLab 2025 - Analytic, Bioanalytic, Microbiology

PharmaLab 2025 - become a speaker at the leading congress on analytics, bioanalytics and microbiology. Meet over 500 colleagues as part of the speaker team in Neuss/Düsseldorf. We also welcome poster requests.

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FDA leitet Übergang zu tierversuchsfreien Testmethoden bei mAbs ein

Am 10. April 2025 kündigte die US-amerikanische Food and Drug Administration (FDA) eine bedeutende Änderung ihrer Richtlinien an, die darauf abzielt, die Anforderungen an Tierversuche bei der Entwicklung von monoklonalen Antikörpern und anderen Arzneimitteln zu reduzieren und möglicherweise ganz abzuschaffen. Diese Initiative soll die Arzneimittelsicherheit verbessern, den Evaluierungsprozess beschleunigen und die Forschungs- und Entwicklungskosten durch den Einsatz humanrelevanter Testmethoden senken.

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Development of a Risk-based Quality System for CMC R&D Laboratories in Drug Development

Drug development requires extensive knowledge, especially in the CMC area, to optimize manufacturing processes, ensure product stability and meet regulatory standards. While there are clear regulatory requirements for CGMP activities, specific guidelines for non-CGMP studies in R&D laboratories are lacking. An article in the Journal of Pharmaceutical Sciences presents a risk-based quality system to help companies ensure the reliability, traceability and regulatory usability of R&D CMC data.

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Europäische Pharmakopöe-Kommission verabschiedet erste allgemeine Texte zu mRNA-Impfstoffen

Die Europäische Pharmakopöe-Kommission (EPK) hat im November 2024 bedeutende Fortschritte erzielt, indem sie erstmals drei allgemeine Texte zur Herstellung und Qualitätskontrolle von mRNA-Impfstoffen und deren Komponenten verabschiedet hat. Diese neuen Richtlinien bieten einen standardisierten Rahmen für Entwickler, Hersteller und Regulierungsbehörden im aufstrebenden Feld der mRNA-Technologie.

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EMA Guideline on Quality, non-clinical and clinical Requirements for Investigational Medicinal Products for Advanced Therapies in Clinical Trials

The European Medicines Agency (EMA) has published a comprehensive guideline detailing the quality, non-clinical and clinical requirements for Advanced Therapy Medicinal Products (ATMPs) in clinical trials. This guideline serves as an important guide for developers and researchers to ensure the safety and efficacy of ATMPs during clinical trials.

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European Pharmacopoeia Commission Adopts First General Texts on mRNA Vaccines

The European Pharmacopoeia Commission (EPC) made significant progress in November 2024 by adopting the first three general texts on the manufacture and quality control of mRNA vaccines and their components. These new guidelines provide a standardized framework for developers, manufacturers and regulators in the emerging field of mRNA technology.

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