Inspections conducted by PEI
Inspections which the Paul-Ehrlich-Institut (PEI) performs under its own responsibility as well as inspections performed by the PEI on behalf of other bodies (EMA or authority of another EU member state) are intended to:
- verify compliance with Good Clinical Practices (GCP) in the context of national clinical trial authorizations and national or European marketing authorizations (GCP-inspections)
- verify information regarding human plasma for fractionation within the scope of the European Plasma Master File (PMF) Certification (PMF-inspections)
- verify pharmacovigilance systems (for human and veterinary medicinal products, haemovigilance and the vigilance of tissues and cells) on a national and European level (PhV-inspections)
- verify the data submitted within the national marketing authorization procedure
These inspections are either directly related to a marketing authorisation for a medicinal product or a clinical trial approval granted by the PEI or to a request for/variation of such an authorisation or approval granted by the PEI or the European Medicines Agency (EMA, incl. the PMF Certification Procedure) or the authority of another EU Member State.
During GCP-Inspections in the context of a national clinical trial approval procedure, the PEI may access premises, equipment, records, quality systems and other relevant resources located at the investigator site, at the sponsor or the contract research organization, the laboratories, the manufacturing sites of investigational medicinal products or other facilities involved. (Section 9 (5) and Section 15 Statutory regulation governing the application of Good Clinical Practice in performing clinical trials with medicines for human use; GCP-Verordnung, GCP-V)
GCP inspections in national, decentralized or centralized authorisation procedures verify the validity of data obtained from clinical trials on the efficacy and safety of medicinal products as well as the compliance with internationally recognised ethical and scientific standards for the conduct of clinical trials.
These inspections are conducted by the PEI on behalf of the EMA. All blood and plasma donation centers, laboratories, transport companies and warehouses located in a third country (e.g. in the USA) and involved in the collection, processing, testing and storage of human plasma for fractionation for import into an EU Member State must be inspected initially and subsequently in regular intervals by European authorities in order to deliver plasma for fractionation into the EU. Only plasma from facilities that comply with European regulatory requirements, including the requirements of the relevant Plasma Master File (PMF), will be accepted for import into the EU for the production of plasma derived medicinal products (PDMP).
In a pharmacovigilance inspection pursuant to Section 62 (6) Medicinal Products Act (MPA), the PEI may review the collection and evaluation of drug risks as well as the coordination of necessary measures in facilities that manufacture or place on the market medicinal products or perform clinical trials. These inspections may be linked to specific reports of adverse reactions or, more generally, verify the correct and functional operation of the pharmacovigilance system of pharmaceutical companies. In addition, the PEI also carries out inspections on tissue vigilance, haemovigilance and the vigilance of veterinary medicinal products.
During inspections within the national marketing authorisation process the PEI may verify information submitted for the marketing authorisation application with the actual situation on site at the pharmaceutical company and at all other sites involved in the manufacturing, testing, development of the medicinal product or the clinical trial. (Section 25 (5) and (8) MPA)
All inspections performed by the PEI on a national basis are carried out in close collaboration with the competent authorities of the federal states.
The fees payable for inspections conducted by the PEI can be found in the Statutory cost regulation for official duties of the Paul-Ehrlich-Institut pursuant to the Medicinal Products Act (PEI-KostVO). Inspections on behalf of the EMA are subject to inspection fees in accordance with the EMA Fees Regulation.
Federal Institute for Vaccines and Biomedical Drugs
Section Inspections of Biomedicines