The Journal of the American Botanical Council
Issue: 70 Page: 62-66
Proposed Quality Control Guidelines for the EU Directive on Traditional Herbal
Medicinal Products: Implications for Small- to Medium-Sized Enterprises
HerbalGram. 2006;70:62-66 ? American Botanical Council
by Josef Brinckmann and Michael McIntyre, MA, DUniv, FNIMH, MBAcC, FRCHM
The European Union recently published draft quality-control guidelines applying to a
new European Directive called the Traditional Herbal Medicinal Products Directive
(THMPD). This Directive allows the licensing and over-the-counter sale of herbs that
have a history of use anywhere in the world for at least 30 years, 15 of which must be in
an EU Member State. Implementing these quality control guidelines is likely to see
companies incur significantly higher costs due to the additional requirements and
complexities of product registration, labeling, and adverse-event reporting. This raises
concerns that the costs for registration of products (especially those with mixtures of
herbs) may be unattainable and uneconomic, resulting in reduction of both traditional
herbal preparations and viable small- to medium-sized herbal companies. This is likely to
mean fewer choices for consumers throughout the EU. On June 20, 2005, the European Medicines Agency (EMEA) published an updated draft
guidance document entitled Guideline on Specifications: Test Procedures and
Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal 1Products / Traditional Herbal Medicinal Products. The deadline for public comment was September 15, 2005. This updated draft guidance aims to make clarifications and
corrections to the earlier Note for Guidance on Specifications, which went into effect 2January 2002. The stated objective of the new guideline is to provide general principles
on the setting and justification of uniform specifications for herbal medicines in order to
support the process of applying for marketing authorization or registration according to 34EU Directives 2001/82/EC and 2001/83/EC, respectively. While a simplified registration procedure was established for Traditional Herbal 5Medicinal Products (THMPs) under EU Directive 2004/24/EC, the guiding principles
for quality, specifications, and documentation are no different for a THMP than for any
other medicinal product (i.e., a drug). Therefore, the updated draft guidance is intended to
be read and understood in conjunction with the Guideline on Quality of Herbal Medicinal 6Products / Traditional Herbal Medicinal Products, another draft guidance document, published in July 2005, the public comment deadline for which was September 30, 2005.
Table 1. Acronyms and Abbreviations CPMP Committee for Proprietary Medicinal Products EHPA European Herbal Practitioners Association
EMEA European Medicines Evaluation Agency GMP Good Manufacturing Practice
HPLC High-performance liquid chromatography MHRA Medicines and Healthcare products Regulatory
PhEur European Pharmacopoeia
QC Quality Control
SME small- to medium-sized enterprises
THMP Traditional Herbal Medicinal Product THMPD Traditional Herbal Medicinal Product Directive TLC Traditional Herbal Medicinal Product Directive
MHRA Implementation of the EU Directive on Traditional Herbal Medicinal
Also in June 2005, directly corresponding to these various EMEA draft guidelines, the
Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom‟s
medicines regulator, issued two consultation letters to industry for comment:
• Consultation Letter: MLX 324: License Fees for Medicinal Products for Human Use 7 Only — Proposals for October 2005 [comment deadline August 29, 2005];
• Consultation Letter: MLX 325: Implementation of the Directive on Traditional Herbal 8Medicinal Products: Directive 2004/24/EC [comment deadline September 8, 2005].
Costs and Complexities of Product Licensing for SMEs While initially proponents of the Traditional Herbal Medicinal Products Directive
(THMPD), up through its passage into law in April 2004, the authors of this article have
subsequently become concerned, based on meetings with regulators as well as with
regulatory affairs consultants, and on briefing papers issued from the EMEA, that the
costs and complexities of product registration may be unattainable for small- to medium-9sized enterprises (SMEs). The authors are involved with enterprises presently in the
process of applying for registrations for THMPs through the MHRA, and are also
submitting comments to the EMEA for its draft guidelines and/or to the MHRA for its
proposals for implementation. Serious concerns have also been expressed recently by
non-EU national governments with a stake in the issue. For example, the Government of
India Commerce and Industries Minister Kamal Nath is urging the EU Trade
Commissioner Peter Mandelson to resolve the non-tariff market access barriers that the
EU THMPD may likely cause for most traditional Indian Ayurvedic medicinal herbal 10 In July 2005 the Secretary of the UK Chinese Medicine Association of products.
Suppliers (CMAS) wrote to the Chair of the Herbal Medicinal Products Committee
within the EMEA expressing concern that the EMEA-proposed new quality guidelines
would effectively bar traditional Chinese herbal formulas from the market.
Scope and General Concepts of the EMEA Guidelines
The scope of the EMEA guideline is specifications, i.e., those tests, procedures, and
acceptance criteria used to assure the quality of the herbal preparations and herbal
medicinal products. In this model, product quality is determined by the quality of the
starting plant material, development, in-process controls, good manufacturing practice
(GMP) controls, and process controls, and by specifications applied to them throughout
development and manufacture. The EMEA document provides details on concepts
followed by the guidelines. General concepts considered to be important in the
development and setting of specifications include:
• Characterization. EMEA proposes that to assure consistent product quality,
comprehensive and relevant specifications for the botanical and phytochemical aspects of
the starting plant material, manufacture, and the finished product, should be established.
• Macroscopical/microscopical characterization. To distinguish the active herb from
• Phytochemical characterization. Analysis of active and marker compounds including
use of chromatographic fingerprinting.
• Potential impurities/Contaminants/Degradation products. Specifications for heavy
metals, pesticide residues, microbial contamination, mycotoxins.
• Biological variation. Evaluation of historical batch data.
• Design and development considerations. EMEA proposes that it may be necessary only
to test the product for quality attributes uniquely associated with the particular dosage
form and/or the specific herbal substance. For example, a certified organic THMP could
have reduced testing requirements for pesticide residues. In certain extracts, depending
on the ethanol content or manufacturing process, testing for microbial limits might be
excluded or reduced.
• Pharmacopeial tests and acceptance criteria. Wherever appropriate, pharmacopeial
methods should be utilized for testing medicinal herbal products.
• Periodic/skip testing. EMEA proposes that performing certain tests on pre-selected
batches and/or at intervals, rather than on every batch, may be justifiable, e.g., dissolution,
solvent residues, and microbiological testing for solid oral dosage forms.
• Release versus shelf-life acceptance criteria. EMEA proposes that it may be acceptable
to establish more restrictive criteria for the quality control (QC) release of a finished
herbal product than for shelf-life specifications. For example, specifications for
degradation product levels.
• In-process tests. Such tests are used for the purpose of adjusting process parameters in-
process, if necessary (e.g., pH of a solution).
• Alternative procedures. EMEA proposes that it may be permissible to use a
spectrophotometric procedure for QC release rather than a chromatographic method.
However, for shelf-life specifications, the chromatographic procedure should still be used
to demonstrate compliance.
• Evolving technologies. New analytical technologies should be used if they offer
additional quality assurance.
• Reference standard. If the botanical raw material does not have a monograph published
in the European Pharmacopoeia (PhEur) or in another EU Member State Pharmacopeia (e.g., British Pharmacopoeia [BP] or German Pharmacopoeia [Deutsches Arzneibuch,
DAB]), an herbarium sample of the herb must be available.
• Statistical concepts. Methods of analysis should be described fully to allow independent
calculation of the results.
Summary of the Proposed Guidelines Specifications: Definition and justification
• Definition of specifications. EMEA proposes that it may be possible that, in addition to
QC release tests, the specification may include in-process tests or periodic (skip) tests
that are not conducted on every batch. In such cases, the applicant should specify which
tests are routine and which are not, with a justification for the testing frequency.
• Justification of specifications. Due to the inherent complexity of medicinal herbal
products, there may not be a single stability-indicating assay or parameter that profiles
the stability characteristics. EMEA suggests that applicants should propose a series of
product-specific, stability indicating tests that would enable the detection of changes in
quality during the product shelf-life. In this regard, EMEA refers applicants to three
additional sets of guidance: Note for guidance on stability testing of new drug substances 11and products, the Guideline on stability testing of new veterinary drug substances and 12medicinal products, and the Note for guidance on stability testing of existing active 13substances and related finished products. • Universal tests/criteria. For implementation of this section of the guidance, EMEA
suggests that the applicant should take into account yet two other sets of guidelines,
14 and Note for guidance on Validation of analytical methods: definitions and terminology,15validation of analytical procedures: methodology.
16• Herbal substances. The PhEur general monograph, Herbal Drugs, should be consulted for
interpretation of the tests (e.g., foreign matter, ash, water soluble extractive, water content,
microbial, mycotoxins, pesticides, etc.) and acceptance criteria (e.g., identification by three or
more of the following: macroscopical, microscopical, chromatographic, chemical reactions, and
organoleptic characteristics) for botanical raw materials.
17• Herbal preparations. The PhEur general monograph, Herbal Drug Preparations, should be
consulted for interpretation of the tests (e.g., residual solvents, water content, microbial limits,
mycotoxins, pesticides) and acceptance criteria (e.g., identification by a combination of
chromatographic tests, e.g., high-performance liquid chromatography (HPLC) and thin-layer
chromatography (TLC)-densitometry, and organoleptic characteristics) for preparations (e.g.,
tinctures, extracts, essential oils, expressed juices, processed exudates).
• Vitamins and minerals in THMPs for human use. Vitamins and minerals may occur as ancillary
substances in THMPs. EMEA proposes that validated assays are required for their identification,
quantification, and determination of impurities.
• Herbal medicinal products. Tests and acceptance criteria considered to be generally applicable
to all medicinal herbal finished products include a qualitative description of the dosage form,
identification as determined by a combination of chromatographic tests (e.g., HPLC and TLC-
densitometry) or, in the case of powders, microscopical and macroscopical characterization in
combination with other methods, validated quantitative assays for active constituents or marker
substances (when actives are not known). A non-specific assay could be justified, as long as other
supporting analytical procedures are also used to achieve overall specificity. For example, a
combination of ultraviolet visible (UV/VIS) spectrophotometric assay for determination of
anthraquinone glycosides with fingerprint chromatography could be acceptable under this
guideline. Additionally, finished products are to be tested, with a justifiable frequency, for
organic and inorganic impurities and residual solvents, as well as microbial limits. Microbial
limits should comply with the PhEur Guidelines.
• Specific tests/criteria. In addition to the aforementioned universal tests.
• Herbal medicinal products. This guidance concerns dosage form-specific tests:
• Tablets and capsules. Dissolution / disintegration, hardness / friability, uniformity of dosage
units, water content, microbial limits.
• Oral liquids. Uniformity of dosage units, pH, microbial limits, antimicrobial preservative
content, antioxidant preservative content, extractables, alcohol content, dissolution, particle size
distribution, redispersibility, rheological properties, specific gravity, reconstitution time, water
• Herbal teas. Loss on drying, total ash / ash insoluble in hydrochloric acid, identification (e.g.,
chromatographic methods, with microscopical and macroscopical characterization if justified),
purity, uniformity of mass / average mass of the sachet, assay (where possible, a specific,
stability-indicating quantitative assay, but non-specific assays can be justified, e.g., UV/VIS
spectrophotometric assay in combination with TLC fingerprint), particle size, and microbial
quality as per PhEur general text on the Microbiological Quality of Pharmaceutical Preparations,
Category 4a. For multi-herb products, where an assay of each herbal substance is not possible, the
applicant can instead justify how reproducibility of the finished product is guaranteed and tested.
*European Herbal Practitioners Association (EHPA) View on the Costs of the Proposed 18Quality Standards
The relatively rigid quality standards being implemented under the THMPD are proving to be
technically difficult, expensive, and in many cases unworkable in practice. The EMEA Guidance 19Note on the Quality of Herbal Medicinal Products calls for tests to demonstrate that the known
constituents of any herbal medicines in the product are present in the finished product. This
Guidance Note states that if an herbal medical product contains a combination of several herbs,
“the determination may be carried jointly for several active substances.” The Note advises that
such identification tests have to be carried out “by different appropriate chromatographic
methods.” The problem here is that demonstrating exactly what is present in the finished product
by chromatographic means is easier said than done. These quality control measures are relatively
easy to carry out for an orthodox drug which contains a single chemical entity but difficult to
demonstrate when evaluating a complex herbal mixture of several herbs, each one containing a
multiplicity of chemical signatures. The bulk of the UK products that are planning to seek
registration under the THMPD are not single ingredient products. Instead, they are likely to be
complex herb mixtures, often with 3 to 5 herbal ingredients and in the case of Ayurvedic and
Chinese herbal medicines, there may be 10 or even 20 individual herbal ingredients. The
proposed quality standards will be difficult, if not impossible in many cases, to apply to these
*The European Herbal Practitioners Association, founded in 1993, represents the interests of
professional herbal practitioners of all traditions and their patients across the EU. The EHPA was
a stakeholder in the Herbal Medicine Regulatory Working Party (2002-3) set up by the UK
Government to advise on the regulation of herbal practice and herbal medicines in the UK.
In practice, when using the relatively inexpensive TLC, the chromatographic fingerprint of one
herb often obscures that of other herbs with which it is combined in a product so that no
determination of the individual marker compounds of all the herbs can be made. It appears that
the only way that these data might be provided for combinations of several herbs is by the use of
HPLC. But even with such equipment the task of identifying markers of several herbs blended
together in one formulation might well prove impossible. The cost of a basic HPLC machine is
about ?50,000 (US $92,000), but the true cost of these procedures has to include the development
of techniques to demonstrate the chemical markers of each herb in combination. This is likely to
be expensive in terms of time and personnel involved and beyond the financial resources of the
many micro, small, and medium companies in the UK herbal sector.
**In response to concerns expressed by the Herbal Forum about these technical difficulties with
regard to the quality guidelines, the MHRA has recently responded:
On the general issue of how to use quality guidelines, we have picked up one point of difficulty
from time to time in our discussions with the Herbal Forum and with some individual companies.
This relates to the concept that the guidelines are there to be followed but sometimes in relation to
an applicant‟s specific product, it may be reasonable for the company to seek to demonstrate that
a particular element of the guidelines is not fully applicable to their situation and that a modified 20approach would be acceptable.
**The Herbal Forum (launched in 2000) is a consortium of representatives of UK herbal
suppliers, manufacturers, and practitioners working together to ensure that changes to UK and EU
herbal legislation are appropriate and proportionate and in the best interests of consumers and the
The point here is that for herbal product complexes containing more than two or three herbs, the
technical difficulties of meeting the EMEA Guidance Note requirements is likely to be a frequent
experience. It is not really reasonable or practical to consider that the majority of these multi-herb
formulations can somehow negotiate the difficulties of the QC guidelines by labelling some of
their herbs as excipients. Thus, these exceptions are likely to be the rule, thereby proving the
Guidelines more or less unworkable for small or medium herb companies with limited resources.
21The Guidance Note mentioned above, together with that on stability testing, also states that by
using the required “appropriate fingerprint chromatograms,” herb companies prove that herbal
constituents within their products are stable. A typical test procedure is likely to occur at three-
month and then six-month intervals over a minimum of three years. Again this testing is likely to
require expensive HPLC machinery, and multiple tests may be required to identify all the active
constituents in a complex herbal formula. For a product with other actives, such as vitamins, this
would again require a further identification and assay for each one. Stability cabinets used to
conduct these tests are not inexpensive. To purchase cabinets capable of holding 20-30 products
samples for up to three years is likely to cost from ?9,000-?12,000 (US $16,500-22,000). The UK
Herbal Forum has recently calculated that the cost of a single herb stability study per packaging
format would be in the region of ?11,000 (US $20,200) per item while a four-herb combination
tablet per packaging format would be in the region of ?31,000 (US $57,000). These are large †sums of money that will be difficult for many herb companies to find. †A well-known German Laboratory recently gave a written cost estimate to an American
applicant, Traditional Medicinals?, for quality assurance and stability testing sufficient to qualify
an herbal tea with two active ingredients for THMPD licensing at approximately a minimum of
100,000 Euros per product (USD $125,380).
Some Possible Solutions Recommended by the EHPA The current guidelines on quality and stability for herbs must be adapted to make them
appropriate for multi-component traditional herbal products. The product-release specification of
compound herbals (where the actives are often undefined) should be based on TLC against
„finger-print‟ standards. Similarly, the stability of the product should be assessed by potential
changes in the TLC profile over time as actives are often not quantifiable and the stability of
“markers” is not necessarily indicative of the stability of the actives. In order to build the “quality picture” of a finished herbal medicine, other associated quality
measures, as described by current CPMP guidelines on herbal medicinal products, should be
employed as appropriate. This would include tests on the herbal active material, aiming at “up front” quality control as well as appropriate and detailed batch documentation, including in-
process records. Solutions must be sought to ensure that the significant costs to small- and
medium-sized businesses of implementing the Directive are minimized and introduced gradually
over the transitional period which runs until 2011.
The EU Directive on THMPs potentially provides a much needed regulatory framework for traditional medicines such as herbal teas, oils, syrups, and tinctures, among others. It may also be considered more logical than the current regulatory framework in the USA, where the same medicinal herbal products are regulated instead as food/dietary supplement products. However, the accumulated costs of the proposed requirements for the development of validated, product-specific, quantitative assays for complex herbal mixtures, along with the product registration fees imposed by the national government and subsequent costs to obtain mutual recognition from other EU national authorities, plus other costs related to pharmacovigilance, labelling in Braille, and user testing for the development of Patient Advice Leaflets, may, in the end, permit only the best-funded large companies to exist in the market. Many traditional herbal medicinal products may disappear as a result. The total costs to bring a single herbal product into the EU market, as understood by the current draft proposals, appear out of reach for micro-, small-, and medium-sized companies.
One of the main objectives of the EU Directive was to establish a harmonized legislative framework for THMPs within the European Community in order to remove existing trade obstacles within the Community while ensuring the full protection of public health and 22maintaining consumer choice. An initial aim of the Directive was to encourage cross-border
trade in THMPs, which is presently quite limited due to significantly different national rules for 23the marketing authorization of THMPs from country to country. If the current proposals are
adopted in their present form, it appears that just the opposite of the original intent of the Directive may take place.
Josef Brinckmann is the Vice President of Research & Development at Traditional Medicinals, Inc. in Sebastopol, California; a Consultant on Market Intelligence for Medicinal Plants & Extracts for the International Trade Centre (ITC) of the United Nations in Geneva, Switzerland; editor of ITC’s quarterly Market News Service for Medicinal Plants & Extracts, and a member of
the Advisory Board of the American Botanical Council.
Michael McIntyre is a former President and an elected Fellow of the National Institute of Medical Herbalists, a Fellow of the Register of Chinese Medicine, Chairman of the European Herbal Practitioners Association and was a member of the UK Department of Health Herbal Medicine Regulatory Working Group. He is visiting Professor at Middlesex University and a Doctor of the University.
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