Infographic – Tasks of the Paul-Ehrlich-Institut on the vaccine pathway

• Scientific advice: The Paul-Ehrlich-Institut offers scientific advice to pharmaceutical companies and thus supports the development of medicinal products from initial discovery through to marketing authorisation and beyond.
• Inspections: The Paul-Ehrlich-Institut carries out inspections during vaccine development and for marketing authorisation. The inspections are directly related to an approval issued by the Paul-Ehrlich-Institut for a clinical trial or to national or international marketing authorisation procedures. For example, inspectors check the completeness and quality of data, documents and processes in connection with clinical trials, as well as the data collected on medicinal product safety.
• Approval of clinical trials: The Paul-Ehrlich-Institut is responsible for approving clinical trials of vaccines and biomedicines. Before vaccines may be tested on humans, the clinical trial must be approved by the Paul-Ehrlich-Institut and must receive a positive evaluation from an ethics committee.
• Marketing authorisation: Medicinal products that are to be marketed in Germany require a national marketing authorisation or a centralised marketing authorisation from the European Commission. For vaccines and biomedicines, the national marketing authorisation is carried out by the Paul-Ehrlich-Institut. The Paul-Ehrlich-Institut is actively involved in European centralised marketing authorisation procedures.
• Batch testing: The Paul-Ehrlich-Institut tests every batch of vaccine and issues a batch release for the German market before the vaccine can be sold and used. The Paul-Ehrlich-Institut will only issue the batch release if the specified criteria for quality, efficacy and safety have been met.
• Safety of medicinal products: Medicinal products and, in particular, vaccines are tested on large numbers of people before they receive marketing authorisation. It is, however, possible that very rare adverse reactions may not yet have been detected at this stage. Even after marketing authorisation, there may be new findings about the safety of a medicinal product which may change its benefit/risk profile. In Germany, the Paul-Ehrlich-Institut collects and evaluates reports on suspected cases of adverse reactions to vaccines and biomedicines.