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EMA published guidance on specifications for herbal products

damienbove — Wed, 16 Nov 2011 11:17:38 +0000

This new EMA guidance document provides general principles on the setting and justification of a uniform set of specifications herbal substances and preparations. Since a simplified registration procedure was established for traditional herbal medicinal products for human use the quality medicinal products is independent of its traditional use. More specifically the addition of vitamins to herbal products need to comply with all the relevant legislation guidance.

This document is concerned with the specific definitions as a list of tests, references to analytical and biological procedures and appropriate acceptance criteria a number of limit ranges and other criteria have been as described and established.

excerpt from regulations

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This guidance document provides general principles on the setting and justification, to the extent possible, of a uniform set of specifications for herbal substances/preparations and herbal medicinal products to support applications for marketing authorisation or registration according to Directives 2001/82/EC and 2001/83/EC as amended. It should be read in conjunction with the ‘Guideline on quality of herbal medicinal products’ (EMA/CPMP/QWP/2819/00, EMA/CVMP/814/00, EMA/HMPC/201116/2005, as revised).
A simplified registration procedure was established for traditional herbal medicinal products for human use under Directive 2004/24/EC. The quality of a medicinal product is independent of its traditional use; therefore all general principles of quality also apply to traditional herbal medicinal products for human use. Traditional herbal medicinal products for human use may additionally contain vitamins or minerals. Concerning these products, this guideline describes specific aspects linked to mixtures of herbal substances/herbal preparations with vitamins and/or minerals. In addition, the quality, specifications and documentation for each vitamin and mineral have to comply with all relevant legislation and guidelines.

A specification is defined as a list of tests, references to analytical and biological procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a herbal substance/preparation or herbal medicinal product should conform to be considered acceptable for its intended use. “Conformance to specifications” means that the herbal substance/preparation or herbal medicinal product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are legally binding quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.
Specifications are one part of a total control strategy for the herbal substance/preparation and herbal medicinal product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterisation during development, upon which specifications are based, adherence to the ‘Guideline on Good Agricultural and Collection Practice (GACP)’ (EMEA/HMPC/246816/2005) and Good Manufacturing Practice (GMP), and a validated manufacturing process, e.g., raw material testing, in-process testing, stability testing, etc.
In the case of herbal medicinal products, specifications are generally applied to the herbal substance, to the herbal preparation and to the herbal medicinal product. Specifications are primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation, and should focus on those characteristics found to be useful in ensuring the safety and efficacy of the herbal substance/preparation and herbal medicinal product.

MHRA Publish Guidance on Organic Herbal Ingredients and Labelling Under THR

admin — Sat, 16 Apr 2011 08:56:50 +0000

MHRA Publish Guidance on Organic Herbal Ingredients and Labelling Under THR

The MHRA considers that consumers would understand “organic” claims to mean that the product meets an independently defined organic standard for herbal medicines. Producers of products presented as organic should therefore be registered and inspected by one of the Certification Bodies (CB) approved by the Department for Environment Food and Rural Affairs (Defra) and their product(s) certified by the CB as meeting these standards.
This is consistent with rulings on “organic” claims for non-food products made by the Advertising Standards Authority.

The active ingredients of a medicine are required to be included quantitatively on the labelling. [Article 54(b) of European Directive 2001/83/EC]. All ingredients in a medicine are required to be stated qualitatively in the patient information leaflet. [Article 59(1) (a) of Directive 2001/83/EC].
Article 62 of the Directive permits the inclusion of additional information which is compatible with the summary of product characteristics, useful for the patient and non-promotional.

Under these current provisions, it is possible for an applicant to include a factual statement that the product contains materials derived from organic production methods. This factual statement must be included within the summary of product characteristics and be verifiable by reference to the data submitted in support of the THR application.
Where companies wish to make non-promotional statements on the label that the herbal medicinal product is organic, it would be the responsibility of the company to provide evidence to support the organic standards in their application for a traditional herbal medicine registration. This would lead to information in the SPC and a simple statement on the labelling and other packaging.
The wording of any such statements must be subordinate in placement and prominence to the statutory information.
Certificates /documentation to support the claim would need to be available to any regulatory body such as the MHRA or ASA in the case of a complaint.

Advertising and promotion of “organic” THR’s must comply with existing guidance as set out in the Blue Guide and the supplementary guidance on consumer advertising for registered traditional herbal medicines.

EMA, The EU Herbal Regulator, Publishes List of References Supporting the Assessment of Ribes Nigrum L., Folium; Blackcurrant Leaf

admin — Tue, 27 Jul 2010 09:15:48 +0000

EMA, The EU Herbal Regulator, Publishes List of References Supporting the Assessment of Ribes Nigrum L., Folium; Blackcurrant Leaf.

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Drug Regulator, EMA (EMEA), Publish Comments Received on Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products / Traditional Herbal Products.

admin — Wed, 19 May 2010 06:53:10 +0000

Drug Regulator, EMA (EMEA), Publish Comments Received on Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products / Traditional Herbal Products.

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Interested party Comment and Rationale Outcome

AESGP We take the benefit of this revision to communicate some minor comments on specific items which are not correct from our point of view or which should be clarified.

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Drug Regulators, EMA, Publish Draft Guidline on the Investigation of Drug Interactions

admin — Wed, 12 May 2010 06:48:53 +0000

Drug Regulators, EMA, Publish Draft Guideline on the Investigation of Drug Interactions.

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The potential for interactions between new medicinal products and already marketed drugs should be evaluated. This applies both to effects of the medicinal product on other drugs as well as the effect of other drugs on the medicinal product. Furthermore the effect of concomitant food intake needs to be investigated. The interaction potential is usually investigated through in vitro studies followed by in vivo studies. In addition, studies in other species may be relevant for studies of pharmacodynamic drug-drug interactions. The results of interaction studies are used to predict a number of other interactions based on the mechanism involved. Treatment recommendations are developed based on the clinical relevance of the interactions and the possibility to make dose adjustments or treatment monitoring. This document aims as providing recommendations on all these issues. General recommendations are also provided for herbal medicinal products.

Drug-drug interactions are a common problem during drug treatment and give rise to a large number of hospital admissions within the EU. The aim of this guideline is to ensure that sufficient knowledge has been gained regarding potential drug interactions with medicinal products and furthermore, that the prescriber receives clear information on the interaction potential as well as practical recommendations on how the interactions should be handled during clinical use. The first CHMP interaction guideline was adopted in 1997 and this is the first revision of this guideline. During the past 20 years, scientific progress has made it possible to predict clinically relevant pharmacokinetic drug interactions based on a limited number of in vitro and in vivo studies. In the last decade, knowledge has been gained in the areas of enzyme induction and drug transport which has opened up the possibility to better predict interactions via these mechanisms. However, in the area of drug transport, the knowledge about clinical consequences of drug-drug interactions is still limited and our understanding needs to be increased. The aim of the interaction studies performed on new medicinal products under development is to gain knowledge on how the new medicinal product affects other medicinal products and vice versa. The interaction potential should be taken into account in the risk-benefit evaluation of the drug. The potential for interactions is mainly investigated before marketing of a drug. Additional studies may be needed post-marketing as follow up measures/commitments or to support variation applications, e.g. for new indications or new dose recommendations. There may also be a need to perform additional studies due to newly gained knowledge as science develops or due to indications of drug interactions reported post marketing. The marketing authorization holder is advised to perform and report interaction studies as needed during the full life-cycle of the medicinal product. This guideline aims to give recommendations and advice on which drug-drug interaction and food-drug interaction studies to perform for medicinal products. The guideline also aims at giving advice on study design, presentation of study results and translation of these results to treatment recommendations in the labeling of the drug. It should be remembered that if justified, other approaches may be used than the ones recommended in this document. The interaction studies performed should be driven by science and by the expected clinical consequences of the interaction. Interactions with specific foods and herbal medicinal products may occur and should be included in the labeling if clinically relevant interactions are expected. General recommendations are presented in the guideline. Interactions with therapeutic proteins, pharmaceutical drug-drug interactions related to physiochemical properties and impact of drugs on clinical chemical laboratory tests are not discussed in this guideline.

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

admin — Mon, 08 Feb 2010 11:19:25 +0000

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

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

admin — Wed, 09 Dec 2009 07:20:05 +0000

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

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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:
• it is legally on the UK market as an unlicensed herbal remedy in accordance with s12(2) of the Medicines Act 1968 and
• was also legally on the UK market under s12(2) at 30 April 2004
It can continue to be marketed as an unlicensed herbal remedy until 30 April 2011 provided it continues to comply with the requirements of s12(2).
This leaflet and flowchart has been produced in an effort to provide guidance which will help those working within the herbal medicine sector to understand and comply with the Traditional Herbal Medicines Registration Scheme (THMRS). The guide covers the key requirements of the THMRS. It does not cover in detail all the areas you will need to consider to meet the requirements of the registration scheme.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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MHRA puts new Traditional Herbal Medicines Registration Scheme Page Live

admin — Tue, 08 Dec 2009 07:19:48 +0000

MHRA puts new Traditional Herbal Medicines Registration Scheme Page Live

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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.

It covers specific and detailed information about the regulation of herbal medicines including the scope of the Legislation, restrictions that apply, who is responsible for applying for registration or other relevant licenses and what these processes involve.

Information on the background to the Directive 2004/24/EC and its European negotiations is available at our Background and policy section.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

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This guideline ap

recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

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IDA adds Herbal Medicines Expertise to Offerings

admin — Wed, 18 Nov 2009 10:13:48 +0000

IDA adds Herbal Medicines Expertise to Offerings

Associate consultant Chantel McGrath (BA, BSC) joins the IDA team. 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.

Her most recent work includes drafting National Institute of Medical Herbalist’s Joint-UK wide consultation on the Report to Ministers from the Department of Health steering Group on the Statutory Regulation of Practitioners of Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK and working as a regulatory and legislation advisor on herbal medicines to the various lobbying organisations.

Key Services

Advice and strategy on the regulatory process involved introducing herbal products through the Traditional Herbal Medicines Registration Scheme (THMRS), including finding scientific peer review research on specific herbs. Market research and planning for herbal medicine drug introduction and practice.
Country Market reports: Providing an overview of the political and economic climate & medical markets, Healthcare systems, regulatory environment, Legal and policy requirements, trade and business organisations, forms of distribution, general market growth forecasts and Public funding, market support mechanisms and Private investment opportunities, R & D initiatives and the competitors, Providing a contacts database of key decision makers within government departments, research institutions, trade and business organisations and manufacturers.
Competitor Reports: Profiles and analysis, covering key commercial indicators such as: product development, market placement, technological or biotechnical viability, consent status, staffing, published company accounts, funding & investment and full analysis of the client’s position within this market.
Design and Concept Reports: Providing the history and evolution of a product and reporting on the predictable and future innovations to aid product conception and development.
Advertising Support: Photo research and slogans for products, advertising copy and design, flyer design, promotional materials and recruitment drives.