title: [Approval of clinical trials of immunobiological medicinal products at the Paul Ehrlich Institute].
abstract: The GCP Directive 2001/20/EG has been implemented in Germany by the 12th Law Amending the Drug Law of 6 August 2004, thereby introducing new regulations for the performance of clinical trials. The amount of the required documentation has increased, but the assessment and the approval of clinical trials as well as scientific advice procedures (national or by the EMEA) allow the early discussion of many details of the development and the non-clinical and clinical testing of the medicinal product with the experts of the Paul Ehrlich Institute (PEI). This might shorten the times required for later marketing authorisation procedures. To facilitate these new tasks, the PEI has created a new central section "Approval of Clinical Trials", which is responsible for the assessment of the clinical trial applications and will coordinate the procedures within the institute. The main topics of clinical trial applications and the particularities of biological/biotechnological medicinal products such as allergens, blood products, vaccines, sera/mAb and products for cell and gene therapy as well as the differences from chemically defined products are discussed.
authors.affiliation: Paul-Ehrlich-Institut, Langen. Kraha@pei.de
authors.forename: H
authors.initials: H
authors.lastname: Krafft
authors.forename: K
authors.initials: K
authors.lastname: Cichutek
mesh_terms: D000047:Academies and Institutes / Q000331:legislation & jurisprudence*; D001685:Biological Factors / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D016208:Databases, Factual / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000627:therapeutic use*; D005060:Europe; D005062:European Union; D018014:Gene Transfer Techniques / Q000941:ethics; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007391:International Cooperation; D007880:Legislation, Drug; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence
chemical_list: D001685:Biological Factors; D015507:Drugs, Investigational; D007155:Immunologic Factors