[The effects of the 12th and 14th amendments to the AMG (Medical Preparations Act) on paediatric pharmaceutical research--a survey of the new regulations]

Abstract

Objective: The 12th amendment to the German Medical Preparations Act (Arzneimittelgesetz, AMG) implements EU-Directive 2001/20EC in national law and introduces changes with regard to academic research in child and adolescent psychiatry. The 14th amendment implements labelling regulations for drugs.

Method: This article analyses the effects of these new regulations on safety aspects, on the performance of clinical trials with and without sponsoring (investigator-initiated trials, IITs), and on the development of paediatric drugs. The former regulatory directives are compared with the changes mandated by the 12th amendment, and their effects on off-label use, long-term safety, and so-called dose-finding studies will be pointed out.

Results: Current law no longer allows post marketing surveillance studies ("Anwendungsbeobachtungen" and "Therapieoptimierungsstudien"). Requirements and procedural regulations are now standardized for all clinical trials with human beings. The term "group benefit" has now been introduced into German law, which excludes research without any direct or group benefit for children participating in a study.

Conclusion: While prerequisites for drug development in accordance with GCP guidelines on a high medical and ethical standard are now granted, due to multiple regulatory requirements, investigator-initiated studies in paediatric psychopharmacology will be more difficult to conduct. Moreover, because of the strict regulations, it is very improbable that academic research will be undertaken without sponsoring (IITs).