پاورپوینت کامل Control of Quality and Safety of Traditional Medicines and Health Supplements 50 اسلاید در PowerPoint

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پاورپوینت کامل Control of Quality and Safety of Traditional Medicines and Health Supplements 50 اسلاید در PowerPoint

اسلاید ۴: 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 ۵: Australia has a strict regulatory system risk basedleads the worldbased on a pharmaceutical regulatory approach pharmaceutical manufacturing standards Regulation of Supplements

اسلاید ۶: 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 ۷: 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 ۸: 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 ۹: 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 ۱۰: 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 ۱۱: 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 ۱۲: 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 ۱۳: 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 ۱۴: 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 ۱۵: 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 ۱۶: 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 ۱۷: 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 ۱۸: 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 clai