[The authorization of clinical trials by the federal authorities].
Since 2004, clinical trials of medicinal products have to be approved by the federal authorities in Germany. Authorization is necessary in addition to the favorable opinion of the concerned ethics committee. This procedure has undoubtedly resulted in larger expenditures with respect to time and costs of planning and conducting of clinical trials. However, the implementation of Good Clinical Practice has also increased both safety for the trial subjects and validity of the data. The most important laws and regulations, definitions, the procedures for submitting a clinical trial application as well as subsequent amendments are described and further information is provided.
Schriever
J
J
Fachgebiet Klinische Prüfungen, Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn. schriever@bfarm.de
Schwarz
G
G
Steffen
C
C
Krafft
H
H
D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D019992:Databases as Topic; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005060:Europe; D005062:European Union; D005858:Germany; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence