title: The legal standards for the radioactive or non radioactive drugs research and approval in the European Community and in Germany after the thalidomide catastrophe.
abstract: The drug thalidomide was contained in the blockbuster Contergan, which has been used as a non- prescription sedative drug and a potent treatment for occurring morning sickness in pregnant women during the 1950s and the early 1960s. This therapeutic use has led to one of the most prominent disasters in the history of drug development due to peripheral neuritis and malformations, e.g. phocomelia, in babies whose mothers had taken thalidomide within their pregnancies. Moreover, this catastrophe initiated a change of paradigm in Germany as well as in Europe with regard to drug safety and the regulatory setting. This article describes the history of the use of thalidomide and the regulatory framework of drug approval at that time as well as changes after the Contergan disaster including considerations to radiopharmaceuticals. Additionally, aspects of drug safety in the different development phases of pharmaceuticals as well as radiopharmaceuticals, i.e. pre-clinical and clinical phases, are characterised. However, many drugs have been withdrawn from the market after approval due to changes with regard of their risk-benefit balance after the occurrence of adverse drug reactions. Thus, pharmacovigilance activities are also mentioned in this review article. Last, obstacles and future perspectives in the arena of drug research and development also considering the use of radiopharmaceuticals are delineated.
authors.forename: Michael
authors.initials: M
authors.lastname: Barsch
authors.forename: Andreas
authors.initials: A
authors.lastname: Otte
mesh_terms: D017277:Drug Approval / Q000266:history* / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000266:history* / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions / Q000266:history*; D005062:European Union; D005260:Female; D005858:Germany; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D011247:Pregnancy; D019275:Radiopharmaceuticals / Q000009:adverse effects* / Q000266:history*; D013792:Thalidomide / Q000266:history*
chemical_list: D019275:Radiopharmaceuticals; D013792:Thalidomide