Drug Development Consultant and Regulatory Consultant

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Drug Regulators EMEA, Publish Overview of Comments Received on Selection of Test Materials for Genotoxicity Testing For Traditional Herbal Medicinal Products

Organisations that commented on the document as released for consultation in June 2009 until September 2009.

1 Association of the European Self-Medication Industry (AESGP) Brussels, Belgium
2 Kooperation Phytopharmaka Bonn, Germany

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Drug Regulators, EMA, Publish Reflection Paper on Ethanol Content in Herbal Medicinal Products and Tranditional Herbal Medicinal Products Used in Children

Herbal medicinal products may contain significant levels of ethanol arising from its use as an extraction solvent in liquid extracts and tinctures or when added as a diluent to liquid herbal preparations. The use of ethanol is necessary for extraction of some constituents that are important for efficacy. Ethanol is metabolically active, therefore formulations without ethanol or with the lowest achievable level should be selected to avoid systemic exposure when the target population is children.

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Drug Regulators, EMA, Publish Overview of Comments Received on Reflection Paper, Ethanol Content in Herbal Medicinal Products

Organisations and/or individuals that commented on the draft Reflection Paper as released for
public consultation on 6 November 2008 until March 15th, 2009.
Organisations and/or individuals
1 Association of the European Self-Medication Industry (AESGP)
2 Kooperation Phytopharmaka, Germany
3 Association of Natural Medicine in Europe (ANME e.V.)
4 German Pharmaceutical Industry Association (BPI)

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Drug Regulators, EMEA, Publish Guidance on Herbal Medicinal Products, Test Materials for Genotoxicity

The ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’ is established by the European Commission based on proposals from the Committee on Herbal Medicinal Products (HMPC), in accordance with Directive 2001/83/EC as amended. The list is being developed gradually through entries of structured information relating to individual herbal substances or preparations.

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MHRA Re-Publish Guidance On How they Regulate Traditional Herbal Medicines (THMRS)

Manufactured herbal medicines1 placed on the UK market are required to have either a Traditional Herbal registration (THR) or a Marketing Authorisation (MA). This applies whether the product is marketed to consumers, herbal practitioners, retailers, or wholesalers. There is one principal exception in relation to herbal medicinal products. Where a manufactured herbal remedy meets both the following requirements

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MHRA puts new Traditional Herbal Medicines Registration Scheme Page Live

This new section has been specifically created to provide practical guidance to help those operating within the herbal medicine sector to understand and comply with the Traditional Herbal Medicines Registration Scheme (THMRS), as required by Directive 2004/24/EC on Traditional Herbal Medicinal Products.

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European Directive on Transitional Qualified Persons for Herbal Medicines

The draft Directive on Traditional Herbal Medicinal Products (THMPD) widens the scope of existing EC legislation to bring certain herbal medicines under Directive to the activities of manufacture and importation (from a third country) to certain herbal medicines

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IDA adds Herbal Medicines Expertise to Offerings

She is a fully qualified medical herbalist and who provides regulatory consultancy on the herbal medicine sector. She has 5 years of experience in producing market research and analysis reports and has built a strong reputation for delivering concise market intelligence and analysis-for clients keen to understand market entry opportunities and barriers in the UK and overseas, with a strength in finding information that is not readily available; simplifying complex legal, planning and financial processes and providing clients with comprehensive contact lists for target markets

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Herbal Drug Regulations – EMEA Draft Guidance on Genotoxicity Testing for Traditional Herbal Medicinal Products

Inclusion in the Community list of a herbal substance/preparation represents a significant advantage to applicants seeking registrations for traditional herbal medicinal products. Progress with the development of Community list is being hampered by the absence of genotoxicity data