How do knowledge management and Open Data improve drug development and approval?

The pharmaceutical industry faces enormous challenges: on the one hand, it faces ever-increasing research and development costs and strict regulations varying from country to country, and on the other hand, it must be able to keep pace with innovation processes. The need for innovative drugs is growing, to which patients should also have quick access to alleviate suffering. Regulatory authorities, in turn, must evaluate and approve new medicines according to their human resources and available knowledge. The application and integration of knowledge management and open data could have positive effects on the innovative ability and accelerated access to medicines. Successes have already been achieved through the implementation of knowledge management means, such as the international harmonisation of evaluation criteria for the approval of drugs, a uniform standardisation of medical terminology and the electronic Common Technical Document (eCTD), a uniform and targeted electronic format for the submission of applications for approval. These already implemented measures and the sufficient recognition of evaluation reports by the approval authorities of other EU member states have saved time and avoided duplication of work. However, this can only be achieved if functioning models are available satisfying the interests of all partners and taking also property rights into account. The Virtual Knowledge Bank for the common data sharing of study data is such a model. The use of knowledge management measures should lead to an improvement in the transfer of knowledge between industry and regulatory authorities and contributes to better cooperation between inspectors and clinical trial investigators.