[Approval of clinical trials with biological medicinal products]

Biological medicinal products can be distinguished from chemically characterized medicines. Their active substance is either extracted or manufactured from organic source materials. Monoclonal antibodies are currently the fastest growing product class in the pharmaceutical sector. The Paul Ehrlich Institute (PEI), an independent federal authority, has the task of assessing the benefits and risks for the purposes of clinical development and approval and after launch onto the market.To ensure the credibility of the results of clinical trials, there are internationally accepted quality requirements for the planning, execution and recording of the trials. The rights, safety and well-being of all participants in clinical trials are to be ensured in the Member States of the European Union (EU). To achieve a common basis for the evaluation at a European level, the goal was to harmonise the regulatory requirements for clinical trials of human drugs. With full entry into force of EU regulation 536/2014 by the fourth quarter of 2018, this objective is being pursued. It is expected that this will result in procedural changes in the course of processes leading to the approval of clinical trials. The content and technical specifications that should ensure that the investigational products are safe and compatible for the subjects or patients should not be influenced by this.