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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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FDA Warning Letter: Unlicensed biological Product, Misbranding and many other Offences

During an inspection, the FDA found serious violations in the manufacture of an amniotic fluid-based product. An official warning letter lists, among other things, the lack of a licence for a medicinal product, violations of good manufacturing practices (CGMP) and misleading labeling - with potentially far-reaching consequences for the company.

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Become a speaker at PharmaLab 2025 - Analytics, Bioanalytics, Microbiology and more

The 13th PharmaLab Congress from November 24-28, 2025 will take place as usual in Neuss/Düsseldorf with two pre-conference workshops and several parallel conferences. As always, it offers you the opportunity to become part of the speaker team and submit a presentation to share your knowledge with colleagues and discuss the respective experiences. So, become part of the team of speakers - and submit your proposal for a presentation via our online form.

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14 Submissions for the Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology 2025

The Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology will once again be presented at the PharmaCongress on 8 and 9 April in Wiesbaden. This year, 14 projects have applied for the award, with topics ranging from optimised technology to AI applications.

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EMA Leitlinie zu Qualitäts-, nichtklinischen und klinischen Anforderungen für Prüfpräparate bei ATMPs

Die Europäische Arzneimittel-Agentur (EMA) hat eine umfassende Leitlinie veröffentlicht, die die Qualitäts-, nichtklinischen und klinischen Anforderungen für Prüfpräparate der fortgeschrittenen Therapien (Advanced Therapy Medicinal Products, ATMPs) in klinischen Studien detailliert beschreibt. Diese Richtlinie dient als wichtiger Leitfaden für Entwickler und Forscher, um die Sicherheit und Wirksamkeit von ATMPs während klinischer Prüfungen sicherzustellen.

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FDA publishes updated Guidance on the accelerated Drug Approval Process for serious Diseases

The U.S. Food and Drug Administration (FDA) has published a new guideline on the accelerated approval process. It is intended to facilitate and accelerate the development and review of new drugs for serious or life-threatening diseases with unmet medical needs.

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Recommendations for determining the Suitability of Donors for human Cells, Tissues and cell-based Products (HCT/Ps)

The U.S. Food and Drug Administration (FDA) has published a guidance document to assist facilities that evaluate donors of human cells, tissues and cell-based products (HCT/Ps). This guidance provides comprehensive recommendations to establish compliance with donor screening and testing requirements.

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EMA Q&A - When is Testing for Endotoxin Masking Effects necessary for biological Products?

The EMA has recently published an update to its question and answer catalog for biological medicinal products. Among other things, it also addresses the question of when endotoxin masking effects must be taken into account for biological products.

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