Question
asked Her Majesty's Government:What steps they have taken to establish whether chromatographic fingerprinting is an appropriate requirement in the testing of multi-ingredient herbal remedies which are to be registered under the traditional herbal medicinal products directive (2004/24/EC); and what estimate they have made of the cost of commissioning such tests for a single product containing several herbal ingredients; and
Answer
Chromatographic fingerprinting is an accepted methodology in the analysis of herbal products and has been included in European guidelines and the European Pharmacopoeia since the early 1990s. With regard to multi-ingredient herbal medicinal products, it is recognised that identification and assay of individual herbal ingredients in the herbal product is difficult to perform and sometimes impossible. The European Committee on Herbal Medicinal Products has recently developed a guideline, in consultation with industry, that addresses the issue of multi-ingredient herbal products. The guideline states that if testing for identity or assay or to demonstrate stability cannot be performed in the herbal product, alternative strategies may be considered. The guideline refers to appropriate fingerprint chromatograms, appropriate overall methods of assay and physical or other appropriate tests. The applicant is therefore able to select appropriate methods and justify their use. The Medicines and Healthcare products Regulatory Agency (MHRA) submitted evidence in 2007 to the Commission’s review of directive 2004/24/EC. In addition, the MHRA has had a number of opportunities—for example, through sharing a platform at conferences—to update Commission officials on the agency’s early experience of the expending number of companies submitting applications under the traditional herbal registration scheme.