Duties of the Paul-Ehrlich-Institut
The duties of the Paul-Ehrlich-Institut are based on the list contained in the "Act on the Establishment of a Federal Agency for Sera and Vaccines" of 7 July 1972. The updating of German and European medicinal product legislation has led to a further development of these duties. Today they include:
- Activities in connection with medicinal product law, concentrating on the following groups of medicinal products
Medicinal products for human use:
sera, vaccines, blood preparations, bone marrow preparations, tissue preparations, allergens, gene transfer medicinal products, somatic cell therapeutics, xenogenic cell therapeutics and genetically manufactured blood components (section 77 AMG).
The BfArM is competent for all other medicinal products for human use.
Medicinal products for veterinary use:
sera, vaccines, immunomodulators and tuberculins ("immunological veterinary medicinal products"), with the exception of immunological veterinary medicinal products against exotic epizootics. For these as well as for immunological veterinary medicinal products not intended for use in animals (e.g. diagnostics), the Friedrich-Loeffler-Institut is the competent authority (section 2 of the German Animal Vaccine Ordinance).
All other veterinary medicinal products are under the responsibility of the Federal Office of Consumer Protection and Food Safety (BVL).
- Approval of clinical trials of the medicinal products for human use within the scope of the Paul-Ehrlich-Institut.
- Participation in the approval of field trials (clinical trials in the veterinary sphere) to be granted by the competent Land agency in connection with the medicinal products for veterinary use within the scope of the Paul-Ehrlich-Institut.
- Processing of applications for marketing authorisation and subsequent applications (change notifications, variations) in the various national and European procedures in connection with the medicinal products for human and veterinary use within the scope of the Paul-Ehrlich-Institut. In the national procedure, the mutual recognition procedure and the decentralised procedure, the Paul-Ehrlich-Institut grants marketing authorisation for the Federal Republic of Germany in the event of a positive outcome; in the centralised procedure the European Commission grants marketing authorisation for the European Union, including the Federal Republic of Germany.
- Official testing and release of batches of the medicinal products within the scope of the Paul-Ehrlich-Institut. The necessary precondition, of course, is that the medicinal products are manufactured in batches. This is not the case, for example, with blood components that are transfused (erythrocytes, blood platelets, plasma). Under certain conditions medicinal products may be exempted from official batch testing.
- Collection and evaluation of reports of adverse reactions to medicinal products (“side effects”) and, if necessary, the taking of appropriate measures (e.g. changing the instructions for use (“package leaflet”), introducing a warning message, recalling a batch, revoking the marketing authorisation).
- Carrying out inspections in connection with the approval of clinical trials and the processing of marketing authorisation applications (national and European); participation in inspections carried out by the competent Land agencies in connection with the granting of manufacturing authorisations and the surveillance of medicinal products, insofar as these are within the scope of the Paul-Ehrlich-Institut.
- Research relating to the groups of medicinal products within the scope of the Paul-Ehrlich-Institut, i.e. in the fields of allergology, bacteriology, biotechnology, immunology, haematology, transfusion medicine and virology. The current research topics are described in the research programme. They include practical topics (e.g. improving methods in batch testing, compiling and characterising standard preparations necessary for experimental testing) as well as more fundamental research (e.g. agent-host interactions).
- Preparation and publication of the annual reports within the co-ordinated reporting system for blood and tissue products. These annual reports serve to provide an overview of the supply situation in Germany for the products listed.
- Advice to various target groups, in particular advice to national, European and international committees in connection with the assessment of risks and the development of guidelines concerning the groups of medicinal products within the scope of the Paul-Ehrlich-Institut. Based on, among other things, the latest standards prevailing in science and technology, applicants are advised on scientific and procedural questions. The Paul-Ehrlich-Institut is also available to the Federal Government, the Land agencies and parliaments for expert information and the development of suggestions for action. Last but not least, it provides information to patients and consumers within the scope of its competence.
The aim of all these measures is to guarantee the quality, efficacy and safety of the medicinal products within the scope of the Paul-Ehrlich-Institut, according to the latest standards prevailing in science and technology, and thus to contribute to the availability of medicinal products with a positive benefit/risk assessment.