Control of Quality and Safety of Traditional Medicines and Health Supplements
اسلاید 1: www.tabaye.ir
اسلاید 2: National Pharmaceutical Control Bureau Ministry of Health Malaysia26 January 2005 tttt tttttVal Johanson - Johanson and Associates Consulting tttttt‘Natural Health Matters’Control of Quality and Safety of Traditional Medicines and Health Supplements - The Australian Experience
اسلاید 3: Overview The Australian regulatory framework The Australian market The Australian Experience
اسلاید 4: Australian Supplements Supplements and traditional medicines are regulated as complementary medicines in Australia Include: vitamins minerals nutritional supplements e.g.glucosamine and chondroitin herbal remedies sports supplements homoeopathic products aromatherapy products- essential oils
اسلاید 5: Australia has a strict regulatory system risk basedleads the worldbased on a pharmaceutical regulatory approach pharmaceutical manufacturing standards Regulation of Supplements
اسلاید 6: Principal Legislation Implemented in February 1991 Therapeutic Goods Act 1989 and amendments Therapeutic Goods Regulations Supported by- Therapeutic Goods Orders for example - Labelling Order, Pills, Tablets and Capsules Standard for Uniform Scheduling of Drugs and Poisons Guidelines for example - AGRCM Codes of Practice e.g. for example- Therapeutic Goods Advertising Code Levels of Evidence Guidelines
اسلاید 7: Objective of Legislation “ To provide a system of controls over the quality, safety and efficacy of medicines including health supplements and traditional herbal medicines and to ensure their timely availability”
اسلاید 8: Complementary Medicines A complementary medicine is defined as: t “a therapeutic good consisting wholly or ttprincipally of one or more designated active tingredients, each of which has a clearly ttestablished identity and:tt(a) a traditional use; ortt(b) any other use prescribed in the Regulations”
اسلاید 9: Traditional Use “is well documented or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and accords with well established procedures of preparation, application and dosage.”
اسلاید 10: Designated Active Ingredients Listed in the regulations and include: amino acids charcoal choline salts essential oils plant or herb material (or their synthetic forms) homoeopathic preparations microorganisms (other than vaccines) minerals including salts mucopolysaccharides non human animal material (or synthetic form) lipids bee products sugars, polysaccharides or carbohydrates vitamins or provitamins
اسلاید 11: Definition of ‘herbal substance’ - “all or part of the plant or substance (other than a pure chemical or a substance of bacterial origin):(a) that is obtained only by drying , crushing, distilling, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol, and(b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.”Herbal Medicines
اسلاید 12: Pharmaceutical manufacturing standards Register of therapeutic goods Positive list of low risk ingredients Expert Evaluation Committee Advertising Code Post market surveillance Adverse reporting systemEssential Regulatory Elements
اسلاید 13: The Australia regulatory system recognises the low risk nature of supplements and herbal remedies and this is reflected in the level of regulation that applies to these products Risk Based System
اسلاید 14: All products must be registered before they can be legally manufactured, exported, imported or supplied in Australia and included in the Australian Register for Therapeutic GoodsTwo registration categorieslow risk listable productshigher risk registerable products Register of Therapeutic Goods
اسلاید 15: Listable products are self assessedlow risk products containing low risk ingredients and making lower level therapeutic claims sophisticated electronic lodgement system validate application details and lodge electronically certification of compliancequick turn around timeAUST L number in 48 hours after payment receivedgo to market as soon as get labels printedlow registration fee $490 and annual charge $530 Low Risk Category
اسلاید 16: Listable complementary medicines can contain only low risk permitted ingredientsThousands of ingredients permitted under lawPermission based either on long history of safe use in Australia or have been evaluated for safety by the expert committeeNew ingredients must comply with the definition of complementary medicine and must be evaluated for safety and approved by the Expert CommitteePositive list of Ingredients
اسلاید 17: Low risk listable products can only make less serious claims symptomatic relief of non serious diseases or conditionshealth maintenancehealth enhancementrisk reduction nutritional supportmay assist in the management of non serious diseases or conditionsClaims for Listed Products
اسلاید 18: Legal requirement for the company to hold evidence to support the claims they make for their product Stronger evidence is required for stronger claims The TGA has developed a Guideline for Levels and Kinds of Evidence to Support Indications and Claims The TGA can call for the evidence if there is a complaint about a claim or as part of their post market surveillanceEvidence to Support Claims
اسلاید 19: Registerable products must be fully evaluated by expert committeeHigher risk products containing more toxic ingredients or making higher level therapeutic claimslonger process more expensive- $780 application fee plus $5000-$36000 evaluation fee and higher annual chargesHigher risk category
اسلاید 20: ‘High’ level claims are permitted on these higher risk products but must be evaluated and approved by the Expert Committee before the products can be registered, advertised or marketed High level claims include:claims for treatment, cure or management PreventionReference to serious conditions or diseasesBetter quality evidence is required to substantiate high level claims as identified in the Guideline Claims for Registerable Products
اسلاید 21: Expert Government Committee with members appointed by the Minister of Health Members include expertise in: complementary medicine, general practice, herbal medicine, nutrition, pharmacognosy, pharmacology, toxicology, naturopathy, regulation and a consumer Responsible for evaluating and providing advice: registerable complementary medicines new ingredients other matters referred by the MinisterComplementary Medicines Evaluation Committee
اسلاید 22: Expert Government Committee with members appointed by the Minister of Health Responsible for:classifying and scheduling substances (drugs and poisons) according to their toxicity providing advice on legislative restrictions and labelling, packaging and advertising of scheduled substances (drugs and poisons)considering matters referred by the MinisterNational Drugs and Poisons Schedule Committee
اسلاید 23: ‘Manufacture’ means any step required to bring the product to their final stateAustralian Code of Good Manufacturing Practice (GMP) is based on the EU/PICS for pharmaceuticals Australian manufacturers must be licensed by TGA to carry out the specific step in manufactureInternational manufacturing facilities must be audited and approved by the TGA Manufacturing Standards
اسلاید 24: Includes raw materials as well as finished product processing assembling packaging labelling storage sterilising testing raw materials testing finished product releasing for supply Licensable steps
اسلاید 25: Information is required to determine the quality of products including identity and impurities:active ingredient specifications identification and validation of the ingredient- particularly herbal ingredients batch certificates of analysisanalytical procedures and validationStability data are required to justify a shelf life and to identify any degradants Quality
اسلاید 26: All Advertisements for complementary Medicines are required by law to comply with the Therapeutic Goods Advertising CodeTherapeutic Goods Advertising Code Council a co-regulatory committee comprises industry, practitioners, consumers and regulatorsresponsible for updating the Code and Advertising Complementary Medicines
اسلاید 27: The definition of advertisement is very broad and means: “any statement, pictorial representation or design, however made, that is intended whether directly or indirectly, to promote the use of supply of the goods”What is an Advertisement
اسلاید 28: Products can be advertised ONLY for the therapeutic claims or indications that have been included in the Register for that productAdvertising Complementary Medicines
اسلاید 29: Provides the rules for advertising therapeutic goods including supplements and herbal medicines to the public Objective is to ensure that the advertising:is socially responsiblepromotes the quality use of medicines does not mislead or deceive the consumerTherapeutic Goods Advertising Code
اسلاید 30: Advertisements for radio, TV, newspapers or magazines must be approved before publication or broadcast Point of sale information and other promotional material including Internet does not require approval but must comply with the Code and the legislation Approval of Advertisements
اسلاید 31: Complaints about advertisements can be made by the public or by other companiesComplaints from main stream media are handled by a co regulatory Complaint PanelIf the complaint is upheld the Panel can:ask for the advertisement to be withdrawnask for a public retraction statement in the same mediarefer it to the TGA for cancellation of product or prosecutionComplaints about other promotional material are handled by the peak industry organisations Complaints
اسلاید 32: All serious reactions to medicines should be reported to the TGAThese are considered and evaluated by the Adverse Drug Reaction Advisory Committee to assess causality, note any trends and make recommendations to the TGA and the Minister Under GMP companies are required to keep a record of all adverse reactions that are reported records inspected at GMP audits Adverse Reaction Reporting System
اسلاید 33: Comprehensive Post Market Surveillance (PMS) backs up the self assessable electronic registration system and provides confidence to consumers and the regulators on quality, safety and efficacyPMS action includes:targeted and random desk based audits (records and info) monitoring suspected adverse reactions ttargeted and random laboratory testing of final product and ingredientsTargeted and random surveillance in the market placeEffective and timely recall proceduresRegular GMP auditsPost Market Surveillance
اسلاید 34: Industry Codes of Practice for: Marketing and Advertising Raw Materials Sports SupplementsComplaint Resolution Committees that deals with complaints Work with Education and Research institutions Industry consults with the Regulatory Bodies to ensure that regulation is appropriate and effectiveSelf Regulation
اسلاید 35: Australia and New Zealand have signed a treaty to establish a Joint Regulatory systemJoint regulatory office to administer the systemSame basic elements as the current Australian regulatory system Pharmaceutical GMP, product licence, Register of products, positive list of safe ingredients, advertising code The new regulatory system with New Zealand is expected to allow more low risk ingredientsNew Agency expected to open its doors in mid 2005Trans Tasman Joint Agency
اسلاید 36: Australian Market Over 1AUD$ billion market Market growing around 15% per yearSold through: Health Food Stores Pharmacy Supermarkets Mail Order/Internet Direct selling (door to door) Health practitioners
اسلاید 37: Australian Industry 4 or 5 big brand companies ttmany small companies 3-4 big manufacturers ttseveral small Mostly contract manufacturers Manufacturers are world standard, high quality and TGA licensed Common market with New Zealand in mid 2005
اسلاید 38: Consumer UseOver 60% of Australians take supplements Nearly 60% of Australians prefer to take a natural product before a pharmaceutical product“In a healing profession obsessed with intervention, invasive technology and drug management, the practitioner has an obligation to his or her patients to use natural healing methods wherever possible, and be very discerning and conservative with investigatory medicine”ttProf John Murtagh- J Comp Med May/June 2004
اسلاید 39: The Australian Experience The Australian Regulatory framework for natural health products leads the world It is a good system that: recognises the low risk nature of natural health products allows therapeutic claims where they can be justified enables fast product registration and access to market provides consumer confidence that the products are high quality, low risk and are efficacious one possible death from Complementary Medicines since the legislation was introduced 14 years ago BUT- it can always be improved
اسلاید 40: Terminology The term ‘complementary medicine’ is not understood by consumers Industry prefers ‘natural health products’ as Canada uses Consumers use these products because they are ‘natural’
اسلاید 41: Administration An office of Complementary Medicine within an Administration that is staffed by pharmaceutical and medical experts brings some challenges and difficulties resulting from a medico-pharmaceutical mindset and culture There is a clear need for regulatory officials who are responsible for interpreting and administering regulations for natural health products to be educated and have expertise in natural healthcare
اسلاید 42: Role of the Peak Industry Association A positive and constructive relationship between the peak industry body and the regulator can achieve much providing a win/win outcome The CHC is the peak industry body for CM in Australia and has been extremely successful and responsible for major changes to the regulatory environment for Complementary medicines
اسلاید 43: Some Achievements of the CHC Establishment of the CM Evaluation Committee Approval of first new CM ingredients (after 9 years) Review of the advertising rules to allow more ttmeaningful claims Establishment of an Office of CM within the TGA Development of Guidelines for Levels of Evidence Development of Guidelines for registration of listable t products Establishment of a co-regulatory advertising system (in conjunction with the other OTC association)
اسلاید 44: Consultation The ‘partnership’ approach that allows constructive consultation with industry has been invaluable and allows industry to contribute to the debate and decision making process prior to legislative change
اسلاید 45: Australian made supplements and herbal products are high quality, low risk and efficacious due to: A stringent regulatory system Pharmaceutical manufacturing standardsRegistration before being manufactured, going to market or being exported or importedPost market surveillanceAdvertising controls Good quality herbs and herbal extractsClean and green environment In Summary-
اسلاید 46: TGA website www.tga.gov.auComplementary Healthcare Council of Australia www.chc.org.auJohanson and Associates websitewww.nhm.johanson.com.auMore Informatio
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