Der Parallelimport von Humanarzneimitteln – neue regulatorische Herausforderungen im Bereich der Pharmakovigilanz

Seit dem Vertrag zur Gründung der Europäischen Wirtschaftsgemeinschaft 1957 ist der freie Warenverkehr innerhalb der Mitgliedstaaten der damaligen Europäischen Wirtschaftsgemeinschaft (EWG) und heutigen Europäischen Union (EU) eine der vier garantierten Grundfreiheiten. Unter diese Freiheit fällt auch der Parallelimport von Arzneimitteln. Allerdings kann in Deutschland ein Arzneimittel nur von einem pharmazeutischen Unternehmer in den Verkehr gebracht werden. Somit sind Parallelimporteure im regulatorischen Sinne pharmazeutische Unternehmer mit allen damit verbundenen Rechten und Pflichten. Im folgenden Beitrag werden die regulatorischen Bedingungen, die damit verbunden sind, vorgestellt

Commentary on the draft revised guideline on the environmental risk assessment of medicinal products for human use

Abstract Applicants for marketing authorisation for human medicinal products in the European Union must submit an environmental risk assessment which is assessed by assessors from the national competent authorities. The EMA guideline on the environmental risk assessment of medicinal products for human use came into effect on 1 December 2006. After 12 years’ experience with the guideline, the EMA has released for public consultation a draft revision of the guideline. The revision proposes significant substantive and structural changes to the guideline. The major changes proposed in the revision are outlined together with the rationale for the changes and the expected impact on stakeholders

Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development

The first microfluidic microphysiological systems (MPS) entered the academic scene more than 15 years ago and were considered an enabling technology to human (patho)biology in vitro and, therefore, provide alternative approaches to laboratory animals in pharmaceutical drug development and academic research. Nowadays, the field generates more than a thousand scientific publications per year. Despite the MPS hype in academia and by platform providers, which says this technology is about to reshape the entire in vitro culture landscape in basic and applied research, MPS approaches have neither been widely adopted by the pharmaceutical industry yet nor reached regulated drug authorization processes at all.Here, 46 leading experts from all stakeholders - academia, MPS supplier industry, pharmaceutical and consumer products industries, and leading regulatory agencies - worldwide have analyzed existing challenges and hurdles along the MPS-based assay life cycle in a second workshop of this kind in June 2019. They identified that the level of qualification of MPS-based assays for a given context of use and a communication gap between stakeholders are the major challenges for industrial adoption by end-users. Finally, a regulatory acceptance dilemma exists against that background. This t4 report elaborates on these findings in detail and summarizes solutions how to overcome the roadblocks. It provides recommendations and a roadmap towards regulatory accepted MPS-based models and assays for patients' benefit and further laboratory animal reduction in drug development. Finally, experts highlighted the potential of MPS-based human disease models to feedback into laboratory animal replacement in basic life science research.publishe

EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

The global regulatory requirements for the assessment of the carcinogenic potential of pharmaceuticals provided for the conduct of long-term carcinogenicity studies in two rodent species, usually the rat and the mouse. Given the their extensive use of animals as well as the costs of these studies, it is in keeping with the mission of International Council on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) to examine whether this practice requiring long-term carcinogenicity studies in two species could be reduced without compromising human safety