The aim of the PEI is to ensure a positive benefit-risk ratio of biomedical drugs and vaccines available on the German and European market by testing and evaluating them.
Areas of responsibility
The PEI conducts its own experimental and pharmacoepidemiological research in the field of biomedicine. It combines drug testing, regulatory research and basic research in a multidisciplinary approach.
The regulatory tasks of the Institute in the field of vaccines and biomedical drugs include
- the marketing authorization, as well as the review and evaluation of marketing authorization applications to the European Medicines Agency (EMA),
- the approval of clinical trials,
- national Good Clinical Practice (GCP) inspections, support for inspections by the competent state authorities and inspections by the EMA,
- government experimental batch testing and batch release independent of the manufacturer,
- the recording and evaluation of adverse drug reactions (pharmacovigilance), and
- the coordination, initiation and implementation of drug risk reduction measures.
With regard to the approval and trade of medicinal products, the PEI assumes an advisory function for the Federal Government and the Länder. It advises applicants on scientific and procedural issues. It also provides information for patients.
The PEI is active in numerous committees and projects of national and international organizations, such as the World Health Organization (WHO), the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM) and the European Commission (EC) and professional societies. For example, it advises national, European, and international bodies on risk assessment and guideline development, and produces reference material to standardize measurement methods and assays. In addition, the WHO Collaborating Center for Quality Assurance of Blood Products and In Vitro Diagnostics and the WHO Collaborating Center for Standardization and Evaluation of Vaccines are located at the PEI. Through the Center for Pandemic Vaccines and Therapeutics (ZEPAI), PEI provides an infrastructure for the fastest possible procurement and distribution of vaccines in the event of a pandemic. Under the GHPP, PEI supports authorities and organizations in sub-Saharan Africa in establishing and expanding drug regimens.
For more information on PEI, click here.
Availability, Quality and Safety of Blood and Blood Products in Africa
Regulatory Capacity Building in the Field of Vaccines: Training and Scientific Advice to Establish Official lot Release
Regulatory Capacity Building in the Field of Vaccines: Training and Advice for Clinical Trials and Pharmacovigilance
Regulatory Training and Advice in the Field of Vaccines and Biomedical Therapeutics