UK experience with the traditional herbal registration scheme

Transcription

1 Safeguarding public health UK experience with the traditional herbal registration scheme ESCOP Symposium Cologne June 2009

2 UK cultural issues... Public perception: natural means safe Historically, herbal medicines largely unregulated Public lack information to identify good quality products; this suits some operators! Slide 2

3 The UK regulatory background. Some herbal medicines have marketing authorisations (often old products) Most herbal medicines supplied as herbal remedies exempt from licensing under s12 of Medicines Act 1968 No specific standards set for quality and safety standards or information about safe use of product A weak regime wide recognition of need for reform Slide 3

4 The MHRA strategy for bringing herbal medicine into effective regulation Slide 4

5 Bringing herbal medicine into effective regulation: MHRA strategy Encourage responsible operators into effective regulation 2. Promote informed consumer choice; aim for it to become the norm for consumers to opt for regulated products 3. Promote compliance with medicines legislation to enhance expectation that compliance is the norm Slide 5

6 MHRA programme to manage regulatory impact of THR scheme MHRA discussions with interest groups during Directive negotiations MHRA fact finding visits to small business MHRA website guidance within 3 months of Directive MHRA programme of workshops eg: herbal pharmacovigilance Sept 08 THR advertising March 09 Regular dialogue with industry s Herbal Forum MHRA runs pre-application notification scheme. Companies submit outline information about likely registrations and receive feedback >150 company meetings held under this scheme UK public assessment reports published Review of herbal PLs allows companies some flexibility over timing Range of pointers guidance notes made available Slide 6

7 Examples of guidance at UK national level.. Transitional Protection guidance about herbal medicines on UK market at April 2004 Sources of evidence of traditional use Examples of indications that might be suitable for THR scheme Who can compile safety report? Guidance on use of HMPC Monographs to demonstrate safety and traditional use (Dec 2007) Slide 7

8 How do I know whether a herbal product would be seen as a medicine by MHRA? On MHRA website.. Guide to what is a medicinal product Borderline Advice form available online Slide 8

9 UK Public Assessment Reports 26 published so far. Slide 9

10 Advice to applicants Pre-submission notification scheme operating since May 2004 meetings with companies > 150 meetings > 800 products Western, TCM, Ayurvedic, Tibetan, South American, African Slide 10

11 MHRA most repeated advice: Keep it simple! Advice to new / inexperienced applicants start with a simple product preferably one active ingredient not 34! sort out the formulation before starting stability trials Slide 11

12 Some products don t fit within Directive 2004/24/EC! new herbal products new combinations / dosage / indications non-herbal ingredients apart from vitamins/minerals have not been used for 30 years or in EU for 15 years therapeutic indications not minor, self-limiting Slide 12

13 Herbal products with non-herbal active ingredients Examples: menthol camphor flavonoids isoflavonoids glucosamine ghee honey rock salt TCM products with animal parts Slide 13

14 Indications not suitable. asthma bleeding fibroids cardiac palpitations consumptive fever diabetes epilepsy glaucoma high blood pressure infertility schizophrenia shortness of breath spondylitis Slide 14

15 Typical points raised on THR applications Summary of Product Characteristics Patient Information Leaflet Labels Evidence of traditional use for specific extracts Slide 15

16 Typical points raised on: the starting plant material Suppliers of plant material Documentation for Good Agricultural & Collection Practices Actual chemical treatments used Assurance that ethylene oxide fumigation not used Slide 16

17 Typical points raised on: Manufacture of the herbal preparation Typical / maximum batch size Further details of process and controls In-process controls Container / closure system / materials Stability data Slide 17

18 Typical points raised on: Specification for herbal preparation Additional identification test Assay for suitable marker Batch data to support the specification Stability data to support storage Slide 18

19 Typical points raised on: Finished herbal product Additional identification test Assay for suitable marker Validation of analytical methods Batch data to support the specification Slide 19

20 Typical points raised on: Finished product stability What to measure Chromatographic fingerprints Stability data to support shelf life Extrapolation of data Update on on-going studies Stability commitments Slide 20

21 Where are we with Traditional Herbal Registrations? Applications received = 70 Applications granted = 32 Herbal substances in applications = 35 Herbal substances registered = 16 Combination products: 10 received / 5 granted Slide 21

22 Cumulative total of THR applications and grants By March 06 By March 07 By March 08 By March 09 Since March 09 THR applications THR grants Slide 22

23 Cumulative total of THR applications and grants for combination products By March 06 By March 07 By March 08 By March 09 Since March 09 Combo THR applications Combo THR grants Slide 23

24 Herbal ingredients registered in THRs Agnus castus fruit Vitex agnus-castus L. Artichoke Cynara scolymus L. Arnica flower Arnica montana L. Black cohosh root Cimicifuga racemosa (L.) Nutt. Devil s Claw root Harpagophytum procumbens (Burch.) DC.ex Meissn Echinacea purpurea root Echinacea purpurea (L.) Moench Feverfew herb Tanacetum parthenium (L.) Schultz Bip. Ginkgo Ginkgo biloba L. Hops Humulus lupulus L. Horse Chestnut seed Aesculus hippocastanum L. Passion Flower herb Passiflora incarnata L. Pelargonium root Pelargonium sidoides DC Rhodiola root Rhodiola rosea L. Saw Palmetto fruit Serenoa repens (W. Bart.) Small St John s Wort herb Hypericum perforatum L. Valerian root Valeriana officinalis L. Slide 24

25 Traditional Herbal Registrations: Pharmaceutical forms Tablets Uncoated tablets Coated tablets Film-coated tablets Gastro-resistant tablets Effervescent tablets Oral liquids Oral drops Capsules Hard capsules Soft capsules Cutaneous gel Slide 25

26 Review of existing herbal Product Licences MHRA priority on Directive 2004/24/EC to bring unlicensed herbal medicines within regulation; major task But - Scope of Directive not restricted to unlicensed products - For historic reasons some former herbal medicines with PLRs had PLs granted on basis of traditional use in the review of medicines - Confusing to have different categories of traditional use Slide 26

27 Review of existing herbal Product Licences Constructive response from industry generally recognise the case and can see some benefits Guidance issued January 2009 Meetings are underway with PL holders (8 to date) Transfers likely to start Summer 2009 Slide 27

28 Traditional Herbal Registrations: Summary Steady flow of applications Reasonable variety of herbal ingredients and indications Continuing dialogue and productive meetings with industry Slide 28

29 Promoting informed choice. We will target key audiences, eg consumer / lifestyle magazines, to explain advantages of users of herbal medicines choosing regulated products Advice to healthcare professionals: helping patients wishing to self medicate with herbals to do so safely. MHRA has registered a THR certification mark with the Intellectual Property Office. (To be made available shortly) Role of industry in responsible advertising; MHRA guidance + workshop on advertising of THRs Slide 29

30 Health care professionals advising patients Drug Safety Update April 2008 Slide 30

31 European developments on traditional herbal registration Growing numbers of HMPC monographs - Mitigates difficulties over Community positive list Mutual recognition of THRs yet to be tested Possible legislative changes affecting THRs: - Coverage of some other ingredients? - Evidence of traditional use from outside EU? Impact of European Commission proposals on pharmacovigilance; possible simplifications for low risk products? Slide 31

32 Underlying issues are significant Disparities between MS over extent of usage of THR scheme Public health protection re eg St John s Wort? - Differences of perspective over well established use vs traditional use within medicines regulation - But more significant is whether SJW supplied within medicines regulatory controls or with no regulation of manufacturing and patient information Impact of recent ECJ judgements on classification of products? Outcome of permitted health claims Slide 32

33 Regulation of herbal medicines made up by or for practitioners in one to one use Slide 33

34 Regulation of herbal medicines prepared by / for practitioners Several thousand herbal practitioners in UK (mainly western herbalism and TCM) - No regulation of practitioners - Weak regulation of unlicensed herbal medicines prepared by practitioners under s12(1) of Medicines Act 1968 Public health issues eg: - Clinics treating patients who may be seriously ill - Some use of low grade / toxic products or ingredients in TCM Slide 34

35 Regulation of herbal medicines prepared by / for practitioners Difficult to improve regulation of unlicensed herbal products unless practitioners are professionally accountable Various reports recommended statutory regulation of herbal practitioners (most recently Pittilo Report 2008) Likely to be consultation on Pittilo Report timing and outcome uncertain Potential complexity of operating regulated market (OTC herbal medicines) alongside largely unregulated market (unlicensed herbal medicines prepared by practitioners) Slide 35

36 Conclusion. Steady growth in number of UK THRs; likely to continue Competitive market in UK likely Continued management of regulatory impact necessary Uncertainty over practitioner regulation may impact on MHRA herbal strategy Uncertainty in EU over relative attractiveness and availability of different regulatory options for herbal products Slide 36

37 Further information MHRA website: (look up traditional on A-Z index) If you are thinking about possible applications to register products in UK and would like advice please use A-Z index on website to find: traditional herbal medicines registration scheme: product registration scheme Thank you..

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