Overview of the Complementary Medicines regulatory framework
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This presentation provides an overview traditional Chinese Medicines with the complementary medicines regulatory framework and the future of complementary medicine regulation
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Overview of the Complementary Medicines regulatory framework
- 1. Overview of the Complementary Medicines regulatory framework Australian Acupuncture and Chinese Medicine Annual Conference Perth 2016 Lyndall Soper, Assistant Secretary Complementary and Over-the-Counter Medicines Branch Medicines Regulation Division Therapeutic Goods Administration 20-22 May 2016
- 2. Overview • The Complementary Medicines regulatory framework • Traditional Chinese Medicines within the regulatory framework • The future of Complementary Medicine regulation Overview of the Complementary Medicines regulatory framework 1
- 3. The challenge Managing industry innovation with consumer safety Minimal regulatory burden Industry Consumer Overview of the Complementary Medicines regulatory framework 2
- 4. Therapeutic Goods Administration • Established in 1989 • Part of the Department of Health • Safeguard health of Australian public • Regulates therapeutic goods (medicines and medical devices) Overview of the Complementary Medicines regulatory framework 3
- 5. What is a Complementary Medicine? Complementary Medicines Herbal Medicines Aromatherapy Products Homoeopathic Medicines Nutritional Supplements Vitamins and Minerals Traditional Medicines Overview of the Complementary Medicines regulatory framework 4
- 6. Why do we regulate complementary medicines? • Safeguard the health of the Australian public • Safe, high quality medicines • Manage adverse events Overview of the Complementary Medicines regulatory framework 5
- 7. What the TGA does not regulate • Practitioners • Cosmetics • Health insurance • Veterinary medicines • Extemporaneously compounded complementary medicines • Food products Overview of the Complementary Medicines regulatory framework 6
- 8. Regulatory Framework for Complementary Medicines • Therapeutic Goods Act 1989 (the Act) • Therapeutic Goods Regulations 1990 • Poisons standard Overview of the Complementary Medicines regulatory framework 7
- 9. A risk-based approach to regulation Australian Register of Therapeutic Goods (ARTG) Listed medicines AUST L • Low level indications • Low risk ingredients • No premarket evaluation of product Registered medicines AUST R Premarket evaluation of: • quality • safety • efficacy Lower risk Higher risk Overview of the Complementary Medicines regulatory framework 8
- 10. Overview of the Complementary Medicines regulatory framework 9
- 11. Listed Medicines Regulatory Framework Medicine listed on the ARTG Post-market compliance Pre- approved ingredients Good manufacturing practice (GMP) Low level therapeutic claims Overview of the Complementary Medicines regulatory framework 10
- 12. Applying for a listed medicine • Electronic application: – Electronic Listing Facility (ELF) • Easy access to market: – Supply within 48 hours of applying Overview of the Complementary Medicines regulatory framework 11
- 13. Pre-approved ingredients Pre-approved ingredients GMP Low level therapeutic claims • Low risk • Some restrictions: • Limits • Route of administration • Plant parts, type of preparation • Labels • Container type Overview of the Complementary Medicines regulatory framework 12
- 14. We are often asked why the TGA does not allow some TCM? • Potential reasons: • Legislative restriction • Negative outcome from previous evaluation • No previous application • Risk based approach • Something that has been used traditionally doesn’t always mean it is safe • Safety concerns require further scientific data to show absence of the concern • We can consider internationally recognised safety reports (e.g. from Health Canada, EFSA) Overview of the Complementary Medicines regulatory framework 13
- 15. Good Manufacturing Practice (GMP) Pre-approved ingredients GMP Low level therapeutic claims • Licence or clearance Overview of the Complementary Medicines regulatory framework 14
- 16. Evidence for Listed Medicines Pre-approved ingredients GMP Low level therapeutic claims • Sponsor: evidence for all indications and claims • Complementary medicines indications: – Traditional – Scientific – Cross-paradigm • Evidence Guidelines Overview of the Complementary Medicines regulatory framework 15
- 17. Listed Medicines Compliance Framework Cancelled from ARTG Fully compliant Non compliant Medicine listed on ARTG Post-market Compliance review Pre- approved ingredients Good manufacturing practice (GMP) Low level therapeutic claims Overview of the Complementary Medicines regulatory framework 16
- 18. TGA: Post market compliance Risk based regulatory approach includes: • desk-based audits of listed medicines – ‘compliance reviews’ • laboratory testing of products and ingredients • monitoring of adverse reactions • recalls • audit of manufacturing sites • controls for advertising Overview of the Complementary Medicines regulatory framework 17
- 19. Post market compliance at our Branch Risk based regulatory approach includes: • desk-based audits of listed medicines – ‘compliance reviews’ • laboratory testing of products and ingredients • monitoring of adverse reactions • recalls • audit of manufacturing sites • controls for advertising Overview of the Complementary Medicines regulatory framework 18
- 20. Registered Complementary Medicines Regulatory Framework Quality Safety Efficacy • If the medicine cannot be listed then it may need to be Registered Overview of the Complementary Medicines regulatory framework 19
- 21. Traditional Indications – Evidence “Tradition of use” • Evidence to show use for its intended purpose for at least 3 generations (75 years) • Only refer to terms within that paradigm Sources of evidence include: • National formularies • Materia medica • Monographs • Official pharmacopoeias e.g. Pharmacopoeia of the People’s Republic of China Overview of the Complementary Medicines regulatory framework 20
- 22. Scientific Indications - Evidence Scientific evidence: • Quantifiable data Sources of evidence include: • Clinical studies • Peer-reviewed published articles • Pharmacopoeias • Systematic reviews Overview of the Complementary Medicines regulatory framework 21
- 23. Traditional Chinese Medicines within the regulatory framework • Adulteration • Aristolochic acids • Homeopathic ingredients Overview of the Complementary Medicines regulatory framework 22
- 24. Traditional Chinese Medicines within the regulatory framework • Adulteration • Aristolochic acids • Homeopathic ingredients Akebia, Asarum, Bragantia, Clematis, Cocculus, Diploclisia, Menispernum, Saussurea, Sinomenium, Stephania, Vladimiria. Products containing Mu Tong and Fang Ji as ingredients also at risk of containing the Aristolochia species. Overview of the Complementary Medicines regulatory framework 23
- 25. Traditional Chinese Medicines within the regulatory framework • Adulteration • Aristolochic acids • Homeopathic ingredients Overview of the Complementary Medicines regulatory framework 24
- 26. Outcomes of the Medicines and Medical Devices Review (MMDR) • 58 recommendations altogether • 19 recommendations for complementary medicines • Included in the Government's 2016-17 budget statements • Watch this space • Department of Health website for more information Overview of the Complementary Medicines regulatory framework 25
- 27. Guidance material • Australian Regulatory Guidelines for Complementary Medicines (ARGCM) • Evidence Guidelines • twitter.com/tgagovau .gov.au Overview of the Complementary Medicines regulatory framework 26
- 28. Contact us Complementary and OTC Medicines Branch • complementary.medicines@tga.gov.au • 1800 020 653 (freecall within Australia) • 02 6232 8634 Report a perceived breach or questionable practices • https://www.tga.gov.au/report-perceived-breach-or-questionable-practices Reporting adverse effects • https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase Overview of the Complementary Medicines regulatory framework 27
Editor's Notes
- Good Morning/Afternoon- My name is Lyndall Soper. I am the head of the Complementary and over the Counter Medicines branch. Today I am going to Cover….. But first I would like to give you a brief snapshot of the Comp Meds industry. Revenue from the complementary medicines industry was around $2.3 Billion a few years ago. Revenue is expected to grow to about $4.6 billion in 2017-2018. There has been a 54% growth in the industry in the last 5 years. There are 48,000 jobs in the industry. Australia exports to more than 20 countries in Asia, Europe and the Americas. Trade with China has significantly ramped up monthly. China is looking for trusted Australian brands, such as milk products and food. Now in 2016, they are looking at nutritional supplements. The TGA is trusted as a world class regulator. Asia is looking for Australian channels because of the trust we have built up with our regulatory system, we have a “clean” and “green” feel, they are looking for “Brand TGA” and “Brand Australia” . The regulatory framework I will discuss today underpins the reputation of Australian companies for producing high quality and safe products.
- The TGA faces a significant challenge: competing interests between industry and consumers. Industry would like less regulation, lighter touch, quicker access to market, however consumers want safe, efficacious and quality medicines and trust in the TGA system to insure they are that way. The TGA takes a risk based approach to regulation to try and balance competing interests.
- A little bit about the TGA- established in 1989. Part of the Australian Government Department of Health. Responsible for regulating therapeutic goods including: prescription medicines, vaccines, sunscreens, medical devices, blood and blood products. OTC & Comp Meds. Responsible for ensuring that therapeutic goods available in Australia are safe and fit for their intended purpose. (quality, safety and efficacy) We look at those goods from 3 angles.
- Encompasses a broad range of traditional and modern low risk medicinal products containing herbs, vitamins, minerals etc. Traditional Chinese Medicines fall under this category.
- We regulate medicines in order to: Protect the health of the Australian public. To meet consumers expectation for safe, high quality medicines. We review adverse event reports and complaints reported to the TGA , these can come from: consumers health professionals pharmaceutical industry, international medicines regulators; or the medical and scientific experts on TGA advisory committees.
- The TGA does not regulate: Practitioners, such as traditional Chinese Medicine practitioners and naturopaths. Cosmetics such as face creams (NICNAS is responsible for regulating cosmetics - National Industrial Chemicals Notification and Assessment Scheme. Health insurance. Veterinary medicines. Complementary medicines that are dispensed or externally extemporaneously compounded by healthcare practitioners for individual patients. Food products - These are regulated by the State/Territories- Sometimes there can be confusion about whether a complementary medicine is a food, we have a tool on the TGA website that helps determine whether a product is a food or therapeutic good.
- In Australia, Complementary medicines are regulated under the Therapeutic Goods Act 1989 (the Act). The Act sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. The law also includes advertising, labelling, and product appearance requirements. The Act is supported by other legal instruments (26BB – permissible ingredients list, TGO 69 – Labelling order). The TGA also needs to consider the Poisons standard when making decisions about medicines. The Poisons Standard, is a legislative instrument that consists of decisions regarding the classification of medicines and poisons into 10 different Schedules, based on risk. This covers everything from; Schedule 1 – NOT CURRENTLY USED Intentionally blank Schedule 2 – Pharmacy Medicine Schedule 3 – Pharmacist Only Medicine (behind the counter) Schedule 4 – Prescription Only Medicine Schedule 5 – Caution – low potential for causing harm Schedule 6 – Poison – moderate potential for causing harm Schedule 7 – Dangerous Poison – high potential to cause harm at low exposure Schedule 8 – Controlled Drug – should be available but restricted to reduce misuse, abuse Schedule 9 – Prohibited Substance, may be abused /misused, only used for medical or scientific research Schedule 10 – Substances of such danger to health as to warrant prohibition of sale, supply and use, eg Carcinogens The Poisons Standard contains important information, advertising and restrictions about each of the substances. The scheduling classification sets the level of control on the AVAILABILITY . The scheduling is implemented through relevant State and Territory legislation.
- The TGA takes a risk based approach to regulation Before being sold, all medicines must be included on the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Act creates a two- tiered system for regulation of all medicines It is a risk-based approach designed to ensure that the level of; regulation, compliance and enforcement activity is commensurate with the risks posed by particular therapeutic goods Lower risk complementary medicines, such as most; vitamin, mineral, herbal and aromatherapy products, are ‘listed’ medicines Listed complementary medicines may be sold anywhere, including health food stores, supermarkets as well as pharmacies. Medicines assessed as having a higher level of risk must be ‘registered’ on the ARTG. Registered medicines can include; prescription, non-prescription and complementary medicines. Prior to registration, these medicines are required to undergo comprehensive assessments of: safety; quality; and efficacy. (this does not happen in the lower risk listed medicines)
- How can you recognise a Listed or Registered product? All products are given a registration number when included on the ARTG Listed Medicines receive a number that begins with AUST L (as you can see in the picture) Registered Medicines are given a number that begins with AUSTR These numbers are normally included on the main label of the medicine Most complementary medicines are LISTED, and therefore have an AUST L number Some higher risk complementary medicines need to be registered, and would therefore have an AUSTR number an example of these higher risk registered complementary medicines include high dose calcium supplements
- Listed medicines containing an “AUST L” are not individually evaluated prior to being supplied in Australia. This means that they must contain ingredients which have been assessed by the TGA for quality and safety (but not efficacy). In addition, a product has to meet certain criteria which I will talk about in more detail on the next slides. A sponsor is required to certify that they have met these conditions before submitting an application for a new medicine. To make sure that sponsors are doing the right thing, my branch undertakes random and targeted-post market compliance reviews for products on the ARTG
- How do you apply for a listed medicine? Sponsors can submit an application through the Electronic listing facility (or ELF) on our website. ELF provides an online facility for sponsors to submit applications for new Listed medicines and updated information about existing listings. The ELF system is based on self certification. Sponsors must certify that the medicine is safe, and that the medicine has evidence to support any claim that it makes. The sponsor is responsible for ensuring they comply with the legislation and all applicable standards/codes (e.g. labelling order and advertising code). The ELF system electronically checks applications based on the validation rules prior to submitting. This ensures, amongst other things, that all the ingredients are pre-approved. The system is based on low risk products which means quicker access to market (sponsors can supply products within 48 hours once on the ARTG)
- I have talked about pre-approved ingredients- Only certain low risk ingredients that have been approved by the TGA are allowed to be used in listed medicines There is a permissible ingredients legislative instrument (26BB) which is a one stop shop list of all ingredients and their restrictions for use in listed medicines The permissible ingredients list can be found on our website. If you want to use a new ingredient that is currently not approved for use in listed medicines, then you may apply for a ‘new complementary medicine substance evaluation’ – you can find it on the TGA website. The primary reason the TGA evaluates a new substance is to determine whether it is of appropriate quality and safety. There are some restrictions for preapproved ingredients – I have some examples here to explain those restrictions; Limits: EPHEDRA is a common ingredient in TCM if it is used as an active ingredient, the total ephedrine concentration from all ingredients in the product must be no more than 0.001%. Route of administration: BARIUM SULFATE: can only be used as an excipient and only in topical medicines for dermal application. Plant part: RHEUM OFFICINALE: The plant part must not be leaf. Labels: PROPOLIS: requires allergy warning statement. Container type: Certain Iron products require a child resistant closure
- When we look at new ingredients, we don’t automatically approve them for use in Listed medicines, even though; they may have a history of traditional use, or; they may be documented in the Chinese pharmacopoeia . There are often 3 reasons why some ingredients are not currently approved for use in listed medicines A legislative reason (e.g. the ingredient or a component falls within the poisons standard and is scheduled) We have previously evaluated the ingredient and the sponsor was not able to demonstrate that it was safe; or No one has previously applied to have a particular ingredient approved Again, we adopt a risk based approach for ingredient assessments. Although a medicine may have been used for hundreds of years in a traditional manner in a specific population; it doesn’t necessarily mean that it is safe for therapeutic use when mass produced, and available for consumption by a larger population. If there is any reason or evidence of a safety concern (e.g. if an ingredient has a genotoxic component), then; we require further scientific data to show absence of genotoxicity. Sponsors can always apply for a new ingredient to be approved by the TGA, and; we can consider internationally recognised safety reports
- Moving on from pre-approved ingredients and into GMP… All listed medicines MUST be manufactured under the principles of Good Manufacturing Practice (GMP). GMP ensures that therapeutic goods are of a high quality. Quality must be built into each batch of product during all stages of the manufacturing process. Our website provides further information on GMP Australian manufacturers must hold a GMP Licence from the TGA Overseas manufacturers must hold a GMP Clearance from the TGA
- Now lets move onto the third important area of the listed medicines framework – Low level therapeutic indications/claims Listed medicines CAN; generally only refer to certain non-serious conditions only make indications that will not lead to unsafe or inappropriate use Listed medicines CANNOT refer to the; treatment of a disease, condition, ailment or defect specified in The Therapeutic Goods Advertising Code Sponsors MUST certify that they hold appropriate evidence for all indications and claims at the time they list their medicine on the ARTG Indications can be: Traditional e.g. “traditionally used in Chinese Medicine to tonify qui (vital energy)” Scientific e.g. “Helps relieve the symptoms of the common cold” Cross-paradigm e.g. “This medicine has been formulated from traditional and non-traditional ingredients to help support a healthy memory” The TGA has Evidence Guidelines (on the website) – you can get more information about how indications are classified.
- Once a medicine is listed on the ARTG, the medicine may be selected for review to assess whether it meets certain regulatory requirements. If the medicine is found to be compliant, it may continue to be supplied, but if there is a breach (e.g. if the products are found to be of unacceptable safety, quality or efficacy) then; the medicine may be cancelled from the ARTG, which means it can no longer be supplied.
- To explain some of our post-market compliance activities in a little more detail… Our approach includes: desk-based audits of listed medicines laboratory testing of products and ingredients monitoring of adverse reactions recalls audit of manufacturing sites controls for advertising We have a number of different branches within the TGA who work together to protect the health and safety of the public
- In my branch, one of the key functions we undertake is desk-based audits which we call compliance reviews. We review labels, advertising material, manufacturing documents and evidence for indications and claims. Since July last year we have completed over 400 reviews. Compliance reviews are categorised either as targeted or random reviews; Targeted reviews: If we receive a complaint about a medicine or another signal about potential compliance issues, we can “target” a medicine In these scenarios, we will request specific information from the sponsor. Random reviews: We randomly select listed medicines from the ARTG and review these We review a standard set of information about the medicines including; The label, manufacturing documents and evidence
- Now, to move onto Registered Medicines. You will recall earlier that I discussed the 2 tiered approach- listed & registered. Registered medicines require premarket evaluation of: quality safety Efficacy If the medicine cannot be listed then registration may be required. This is usually if; the ingredients are not available for use in Listed medicines (e.g. if the ingredient is not listed in the permissible ingredients list) the medicine makes higher level therapeutic claims (e.g. used for anaemia or osteoporosis) The data requirements and level of evaluation for registered medicines are higher. The individual medicines are fully evaluated prior to being supplied in Australia. This is a different process to the Listed medicines process. Most TCM are within the Listed space
- ALLISON presenting now Traditional indications must indicate that the health benefit is based on long term use and experience in a specific traditional paradigm. Evidence of a tradition of use will show that the medicine was used for its intended purpose for at least 3 generations (75 years). Traditional indications should not refer to terms that are not within that specific paradigm (e.g. cell oxidation) or conditions that cannot be diagnosed within the specified paradigm, e.g.: ‘Traditionally used in Chinese medicine to increase bone mineral density’ is inappropriate, bone mineral density cannot be monitored or determined without conventional medical intervention. Traditional evidence: Not based on scientific evidence therefore they cannot imply efficacy in a clinical setting, support a mechanism of action or an underlying physiological process. Sources of traditional evidence include: National formularies Materia medica Monographs Official pharmacopoeias e.g. Pharmacopoeia of the People’s Republic of China
- Scientific indications must be supported with scientific evidence which demonstrates quantifiable data Sources of scientific evidence include: clinical studies, peer-reviewed published articles, scientifically based pharmacopoeias and systematic reviews.
- Very roughly, 5% of all Listed medicines are Traditional Chinese Medicines (TCM). Similarly 5% of all our random and targeted reviews are on TCM products. We want to raise awareness with your stakeholders of some of the opportunities for improvement the TGA sees in the TCM space. It is important to be aware of some of these risks, especially when TCM health practitioners are prescribing, and consumers are using these products. Higher risk of Adulteration: One of the issues we see in the compliance space is that TCMs have been found to be adulterated with high-risk substances heavy metals: we conduct random surveys of TCMs – in 2014 we did a survey of >40 TCMs for levels of heavy metals, two were recalled as a result. scheduled medicines: Dr Ming’s Chinese capsule contained sildenafil (in viagra – prescription only). Also the place of manufacture was not approved by the TGA. sibutramine (a prescription medicine withdrawn from Australian market in 2010 as it caused cardiovascular events) – often adulterated in weight loss products
- Aristolochic acids (AA): TGA is concerned about TCM that are known/suspected to contain Aristolochia species. AAs are associated with severe kidney damage and urinary tract cancer All species of Aristolochia are prohibited for supply, sale or use in therapeutic goods in Australia. However, Aristolochia species appear to be finding their way into some herbal-based Traditional Chinese Medicine products because they may be confused with other herbs of similar appearance or similar name. It is a condition of listing that evidence for each batch of potentially contaminated product must be provided to TGA to demonstrate absence of AA. Herbal species most vulnerable to substitution by Aristolochia include some species of the following herbs … (list at the top right of the slide) Healthcare practitioners asked to take extreme caution in using herbal products, in raw or formulated form, if they contain any of the herbs listed above. If uncertain about the identity and authenticity, consider discontinuing their use. More information on TGA website under “safety alerts”
- Homeopathic ingredients: The medicine may include ingredients as “homeopathic” (on the ARTG entry and or label) when they are not actually in a homeopathic concentration. Homeopathic concentrations are very diluted (must be over 1000 fold). Certain ingredients can only be allowed for use in listed medicines if they are for homeopathic use ie. Over 1000 fold dilution. We have observed that there is sometimes a misunderstanding of what “homeopathic” is. This leads to sponsors using substances which are stated to be homoeopathic yet more concentrated than a 1000 fold and as such, wouldn’t be listable. This is a safety concern. E.g. product includes arsenic as an active ingredient. Arsenic is only permitted for use as a homoeopathic ingredient. However the sponsor has included arsenic at a greater concentration than 1000 fold dilution.
- Last year a review was completed of Medicines & Medical devices regulation- read from slide. The Government should announce their response to the Expert Panel Review of medicines and Medical Devices Regulation. Based on the Government's response, the Department will begin design and implementation of the agreed reforms. Some relevant recommendations: Comp meds continue to be regulated within TG framework. Catalogue of approved ingredients (permissible ingredients list) Permitted indications – work has been done on this in the past New listing pathways Monographs Increasing post market monitoring There will be consultation – the engagement of TCM stakeholders in that process would be valuable in shaping the future of your industry. For all the recommendations the MMDR report is available on the Department of Health website.
- My branch has developed guidance materials to help the industry understand the complementary medicines regulatory framework. ARGCM - Our main guidance document. TGA website – safety alerts, announcements, more information Twitter feed
- Contact us We would love to see more representation from the TCM industry, we value your feedback and welcome the opportunity to talk further with you about any specific concerns or insights into your industry that you may be able to provide us. Please speak to us to let us know how we can improve our interactions and what we can do to work better. You can contact COMB via the details on the slide. You can also…. Report a perceived breach or questionable practices Report a perceived breach of the Therapeutic Goods Act or report questionable practices in relation to therapeutic products For example: someone supplying an unapproved therapeutic product, questionable manufacturing practices, counterfeit medicines etc. Adverse event reporting In the online system, you can report a case of a suspected adverse reaction in association with a medicine (including complementary medicines). The TGA relies on the public, health professionals and industry to report problems with medicines or medical devices - this allows us to identify and respond to safety matters. We would really value this information from industry members and practitioners who are at the coalface of the consumer interaction with these medicines. Thank you