RDW - pharmaceutical development continues after issue of marketing authorisation

The medicine’s development does not end with the issuance of the marketing authorisation. Pharmaceutical companies continue the investigations on their medicinal products, gathering information on their benefits and adverse properties.

A medicine generates information throughout its life, even after its introduction. This data is generated in patient systems and national registers. The information in data lakes and registers can be utilised throughout the medicine’s life cycle.

The pharmaceutical companies are obliged to produce updated information for the authorities and the medicine users.

The term Real World Data (RWD) refers to any data that is stored in real time. This data may be generated on patients during treatments or information stored by people themselves through various platforms or applications, or data generated in a register maintained by the authorities, for example, on benefits or medicines reimbursements. In health sector research, RWD provides useful information related to clinical trials, safety monitoring, use of medicines as well as effectiveness of therapies.

The effectiveness of the therapy is an indicator of the health benefit obtained by the patient. For example, pharmacotherapy is an investment and its societal benefits can be studied by looking at the effectiveness of therapy. The effectiveness of pharmacotherapies can only be studied once they have been introduced. Before the introduction, the information is only based on the quality, efficacy and safety studies made for the marketing authorisation.