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IHTA Annual Conference. The Irish Medicines Board and the regulation of herbal and other medicines. Crowne Plaza Hotel, Dublin Airport - 28 th April 2010. Dr. J.M. Morris Senior Scientific Advisor, IMB. Overview. Introduction to medicines regulation Classification of products as medicines

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Ihta annual conference

IHTA Annual Conference

The Irish Medicines Board and the regulation of herbal and other medicines

Crowne Plaza Hotel, Dublin Airport - 28th April 2010

Dr. J.M. Morris

Senior Scientific Advisor, IMB


Overview

Overview

  • Introduction to medicines regulation

  • Classification of products as medicines

  • Herbal medicines regulatory framework

  • Homeopathic medicines

  • Other medicines

  • Herbal medicines post 2011

  • Conclusions and questions


What is a medicine i

What is a Medicine I

  • Definition given in Article 1.2 of Directive 2001/83/EC

  • Revision in Directive 2004/27/EC

  • IMB guide to definition of a medicinal product for human use based on

    • Composition

    • Claim

    • Presentation

    • Function


What is a medicine ii

What is a Medicine II

Article I of Directive 2001/83/EC, as amended by Directive 2004/27/EC makes changes to the definition of a Medicinal Product. The new definition states that a medicinal product is:

  • Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

  • Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.


Requirements of medicinal products

Requirements of Medicinal Products

  • Marketing is controlled by valid authorisation or registration

  • Protection of consumers

  • Medicines should be of good quality

  • Risk of using the product should be reasonable and acceptable in the light of the expected benefit

  • Demonstrable therapeutic benefit should be anticipated


Imb guideline definition of a human medicine

IMB Guideline “Definition of a Human Medicine”

  • Non-legally binding advice – definition is in the Directive

  • Borderline between MP’s and foods, cosmetics, Medical Devices etc.

  • Adjudication by IMB Classification Committee

  • Application form and fee

  • Guideline revised February 2008


Classification process 1

Classification Process 1

  • Application form on IMB website

    www.imb.ie

  • Complete application form in full

  • Enclose all labels, leaflets, promotional

    material

  • Pay attention to websites used to promote products

  • Application fee €250 (€200 for supplements)

  • Submit to Classification Committee

  • Response usually within 28 days


Imb classification committee

IMB Classification Committee

  • Multidisciplinary scientific in-house committee

  • Consists of representatives from Human Medicines, Medical Devices, Compliance Departments

  • Expertise in medicine, pharmacy, herbal medicine, toxicology, market surveillance and pharmacovigilance , medical devices, cosmetics.

  • Meets once monthly

  • Typically 100 applications p.a

  • Provides a formal response in writing

  • Decisions can be appealed to ACHM (final)


Classification process 2

Classification Process 2

  • Open to dialogue – removing a claim or even changing language may alter status

  • Consultation with other interested parties – e.g. FSAI for food supplements

  • Two way process – FSAI makes referrals to IMB also

  • Same active may be present in medicines and foods – e.g, garlic, ginger

  • Some herbs may be present exclusively in foods i.e. not medicines provided no claims made


Directive on traditional herbal medicinal products thmps

Directive on Traditional Herbal Medicinal Products [THMPs]

  • Must meet pre-defined standards:

    • - Quality

    • - Safety

    • - Traditional Use


Quality

Quality

  • All traditional medicinal products must conform to agreed quality standards as for any other medicinal product

  • Herbal Medicinal Product Guidelines – HMPWP

  • 2001/83/EC - where appropriate

  • New legislation 2004/24/EC

  • EMA guidelines

  • European Pharmacopoeia monographs


Efficacy

Efficacy

  • Full product authorisation application

    => clinical trial data

  • Well-established use’

    => bibliographic applications

  • 2004/24/EC -30 years on market, at least 15 in EU for THMP registration


Manufacturing considerations

Manufacturing considerations

  • Good Agricultural Practice [GAP]

  • Good Manufacturing Practice [GMP]

    Manufacturer’s Authorisation

  • Good Distribution Practice [GDP]

    Manufacturer’s/Wholesaler’s Authorisation

    Third country importation = manufacture


Eu irish initiatives

EU/Irish initiatives

  • European Scientific Co-Operative on Phytotherapy [ESCOP]

  • Pharmaceutical Committee of the European Union

  • Herbal Medicinal Products Working Committee [HMPC]/Other Working Parties of the European Medicines Agency

  • IMB Herbal Medicines Project 2000 - 2002


Homeopathic medicines

Homeopathic medicines

  • Simplified Registration Procedure provided for in 2001/83/EC Chapter 2

  • No Hom MP on the market unless it has a MA or SRP

  • National Rules Scheme adopted in Ireland to allow limited claims on basis of supporting data


Simplified registration

Simplified registration

  • Products administered orally or topically

  • No specific medicinal claims on labels and literature

  • Sufficient degree of dilution I in 10,000 or 1/100th of smallest allopathic dose of POM

  • That is 4x(4d)-2C – or greater dilution (potency)


Documents to be submitted

Documents to be submitted

  • Details of product and stock

  • Details of preparation and control of stock(s)

  • Manufacturing and control file for product

  • Manufacturing authorisation

  • Registrations in other MS

  • Mock-ups of packaging

  • Product stability data


Srp products

SRP Products

  • Exempt from authorisation-no SPC

  • Exempt from pharmacovigilance

  • Labelling requirements- Article 69

    • Scientific name of stock(s) and dilution level

    • Name and address of reg holder

    • “Homeopathic medicinal product without approved therapeutic indication”

    • No other detail other than as specified


Homeopathic medicines national rules scheme 2010

Homeopathic Medicines National Rules Scheme 2010

  • Article 16.2 of Directive 2001/83/EC

  • Implemented by Regulation 11 of SI 540 of 2007

  • Product is a homeopathic medicine i.e. prepared from homeopathic stocks using a recognised manufacturing procedure (Pharmacopoeia)

  • Indication is appropriate

  • Indication does not need medical diagnosis/intervention

  • Efficacy established in Ireland

  • Safety evaluated


Homeopathic national rules 2 safety evaluation

Homeopathic National Rules (2) Safety evaluation

  • Reference to published literature

  • Oral products derived from food substances

  • Active used in allopathic medicine dilution of 1 in 10,000 minimum (nmt1/100th therapeutic dose)

  • 1 part per 10,000 MT


Homeopathic medicines national rules labelling

Homeopathic medicines national rules labelling

  • General labelling requirements of Directive (TitleV)

  • The product is a homeopathic medicinal product authorised by this procedure

  • Any evidence of efficacy is not based on clinical trials

  • Use for symptomatic relief of the condition specified

  • Consult a Doctor if symptoms persist


Other medicines

Other medicines

  • Anthroposophic medicines

    - regulated as medicines when manufactured by a homeopathic (pharmacopoeial) method

  • “Spagyrics”

    – methods unlikely to be approved in the pharmacopoeia

  • HMM Group of Experts at Ph. Eur making good progress


Other medicines 2

Other medicines 2

  • Korsakovian dilutions (k potencies) may be included in pharmacopoeia

  • Bach flower remedies remain outside legislation

  • Aromatherapy products not regarded as medicines unless specific claims made


Herbal medicines post 2011

Herbal Medicines post 2011

  • Since July 27th 2007 no new THMP can come on the market without PRIOR IMB approval

  • Existing herbal medicines can remain on the market up to 30/4/2011

  • Applications should be received by IMB for by end April 2010 (THMP or WEU)

  • Products with PA’s can of course continue to be marketed

  • Few applications received

  • Problem not restricted to Ireland – same across EU generally


Herbal medicines post 2011 2

Herbal Medicines post 2011 (2)

  • Few registrations

  • Herbal medicines masquerading as foods

  • “Health claims” vs. medicinal claims

  • Illegal products

  • Marketplace availability of herbal products?


Herbal medicines post 2011 3

Herbal Medicines post 2011 (3)

  • What can IMB do?

  • All products need to be registered

    - as herbal medicines

    - as food supplements

  • Registration with IMB or FSAI as appropriate

  • Documented proof of legal status

  • No documentation - expect products to be seized


Herbal medicines registration

Herbal Medicines Registration

  • Registration process is feasible and user friendly

  • IMB is now the primary authority for determining method of sale and supply

  • No longer bound by the restrictions of prescription legislation

  • For example Ginkgo biloba could be accepted for THM registration provided suitable indication


Herbal medicines registration 2

Herbal Medicines Registration (2)

  • IMB aiming constantly to improve clarity of the registration process

  • Developing lists of herbal substances which can only be considered as medicines

  • ExamplesG. biloba

    A. belladonna

    H. perforatum

  • Some of these might be acceptable OTC once registered as THM’s

    e.g. Ginkgo

    Valerian


Herbal medicine registration 3

Herbal Medicine Registration (3)

  • IMB also developing a list of herbal substances acceptable for marketing as foods provided no medicinal claims made

  • Developing policy in conjunction with

    -IMB expert Herbal sub-Committee

    -FSAI

    -DOHC

    -Industry

  • Draft list has approximately 150 entries

  • Looking forward to further discussion


Conclusion

Conclusion

  • Need to be aware of the distinction between medicines and foods

  • IMB Classification process is there to assist

  • Herbal and homeopathic medicines require registration or authorisation by April 2011

  • New national rules scheme introduced for authorisation of homeopathic medicines with limited indications

  • Herbal medicines registration scheme up and running

  • “Positive” and “negative” lists being developed to help improve clarity

  • 30/4/2011 is only 1 year away


Questions

Questions

Thank you for your

attention


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