First adaption of German AMNOG to the EU HTA Regulation: With the German Federal Ministry of Health's recent adoption of the respective ordinance in Germany (AMNutzenV), the German legislator took a first step to integrate...more
Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more
On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 2: Clinical Trials Information System - This part of the series is about the Clinical...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 1: Transitional period and timeline Do you wonder when you need to apply the new rules...more
Step by step towards self-testing: Due to the Covid-19 pandemic, which continues to impinge upon everyday life, the German Federal Ministry of Health (Bundesministerium für Gesundheit, “BMG”), after approving the distribution...more
Seit Monaten wird die Frage kontrovers diskutiert, ob Probenentnahme-Sets zur Feststellung einer SARS-CoV-2 Infektion oder entsprechender Antikörper an jedermann abgegeben werden dürfen oder nicht....more
For months now there has been ongoing controversial debate about whether or not specimen-collecting kits for the detection of a SARS-CoV-2 infection or related antibodies may be furnished to members of the general public. ...more
Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and Medical Devices (BfArM) and...more