Assessment of genotoxicity of herbal medicinal products: a co-ordinated approach.
The submission of data on genotoxicity is a precondition for marketing authorisation respectively registration of herbal medicinal products (HMPs) with well established or traditional use in some countries. In European regulatory guidelines prepared by the Committee on Herbal Medicinal Products (HMPC) of the European drug regulatory agency EMA, a test strategy is defined giving a pragmatic framework adapted to the assessment of the potential genotoxicity of HMPs. It describes a stepwise approach, including the possibility to reduce the number of extracts of a herbal drug to be tested by the use of a bracketing and matrixing approach. According to this strategy, Kooperation Phytopharmaka, a scientific society in the field of HMPs, has so far coordinated the conduction of genotoxicity tests for 30 herbal drugs within the frame of a joint project of several manufacturers of HMPs. Results are delivered to the cooperation partners for use in regulatory applications.
Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, D-53173 Bonn, Germany.
Olaf
O
Kelber
Barbara
B
Steinhoff
Karin
K
Kraft
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug / Q000592:standards; D040541:Marketing / Q000331:legislation & jurisprudence; D008519:Medicine, Traditional / Q000379:methods*; D009152:Mutagenicity Tests; D010602:Pharmacopoeias as Topic; D008517:Phytotherapy / Q000592:standards*; D028321:Plant Preparations / Q000592:standards*; D011786:Quality Control; D012042:Registries / Q000592:standards
D028321:Plant Preparations