[Pharmaceutical Products and Medical Devices: Authorization and Conformity Assessment Procedures, Regulatory Data Protection, Patent Protection and Supplementary Protection Certificate].

Pharmaceutical products and medical devices can pose a potenzial risk to health. They may therefore only be placed on the market if their safety, efficacy and quality have been proven. The safety requirements are not to be understood as absolute.

Bedside manufacturing as the next step in personalized medicine: medical progress and legal challenges.

Bedside manufacturing is having a revival in healthcare, with a promise to revolutionize personalized medicine through on-site drug production. While this concept holds considerable promise, it also encounters a complex web of legal uncertainties. The current regulatory framework in Switzerland and the EU, which includes the Swiss Therapeutic Products Act and the EU directives, regulations, and guidelines, fails to adequately address its distinct challenges.

Genetic Material and Sequence Data to Protect Global Health in the Light of Pandemic Outbreaks: Mapping the Legal Landscape under European and International Law.

The current pandemic outbreak of corona virus SARS-CoV-2 shows the need for comprehensive European cooperation in drug development and the importance of genetic material and sequence data in research concerning this unknown disease. As corona virus SARS-CoV-2 is spreading across Europe and worldwide, national authorities and the European Union (EU) institutions do their utmost to address the pandemic and accelerate innovation to protect global health. In order to be prepared and to be able to respond immediately to serious epidemic and pandemic diseases, the EU has already adopted the Decision No (EU) 1082/2013 on serious cross-border threats to health.

A new transgenic rat model overexpressing the angiotensin II type 2 receptor provides evidence for inhibition of cell proliferation in the outer adrenal cortex.

This study aimed to elucidate the role of the AT(2) receptor (AT(2)R), which is expressed and upregulated in the adrenal zona glomerulosa (ZG) under conditions of increased aldosterone production. We developed a novel transgenic rat (TGR; TGRCXmAT(2)R) that overexpresses the AT(2)R in the adrenal gland, heart, kidney, brain, skeletal muscle, testes, lung, spleen, aorta, and vein. As a consequence the total angiotensin II (Ang II) binding sites increased 7.