In 2021 the EU proposed harmonized rules on Artificial Intelligence (AI Act) as currently most countries have national AI strategies and regulations. The EU is set to become the global hub for trustworthy artificial intelligence (AI), so-called ecosystem of trust. Based on the upcoming regulation there is a high probability future IT-applications in the Pharma and BioTech sector could be considered as high-risk AI-applications and therefore need to meet considerable legal requirements of the AI Act. Especially in the Biotech and Pharma sector with the analysis and processing of biological data, DNA and RNA the AI Act needs to be evaluated with regard to its effects on the use and development of sophisticated selection processes based on IT-applications, which rely on AI-techniques. A possible solution to strike the delicate balance between the regulatory need to provide safety and the high pace of technology development can be generated by the application of so called sandbox regimes. In its current form, the far-reaching risk-based approach reflected in the AI Act may impede the rapid development of AI-applications in the EU. Therefore, the design of innovation friendly and effective Sandbox-Regimes is key in order to keep innovation in the EU as well as to help cure human diseases by using modern AI systems for faster and more efficient development of biopharmaceuticals.