presentation: the regulation of complementary …...2015/03/25 · the regulation of complementary...
TRANSCRIPT
The regulation of complementary medicines
Yasmin Mollah Assistant Director, Listing Operations Angeliza Querubin Pre-Market Assessment Section Complementary medicines branch, TGA Capsig NSW - Complementary medicines - revival 25/3/2015
Therapeutic Goods Administration What do we do?
• Established in 1989
• Department of Health of Australia
• Safeguard health of Australian public
• Regulates therapeutic goods – Medicines and medical
devices
TGA Structure National Manager
Market Authorisation Division
Medicines Authorisation Branch
Complementary Medicines Branch
Devices Authorisation Branch
Scientific Evaluation and Special Product Access
Branch
Monitoring and Compliance Division
Regulatory Compliance Branch
Manufacturing Quality Branch
Laboratories Branch
Post Market Surveillance Branch
Regulatory Support Division
Regulatory Business Services Branch
Regulatory Engagement, Education and Planning
Branch
Regulatory Legal Services Branch
Regulatory knowledge and Technology Services Branch
Regulatory Business Improvement Branch
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Complementary Medicines Branch Market
Authorisation Group
MAB (Medicines)
CMB (Complementary
Medicines)
Regulatory Reform &
Coordination
Pre-market Assessment
Listing and Operations
Listing Compliance
DAB (Medical Devices)
SESPAB (Scientific
Evaluation)
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What are Complementary Medicines?
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The TGA does not regulate: • Practitioners, such as naturopaths,
traditional Chinese Medicine practitioners • Complementary medicines that are
dispensed or extemporaneously compounded by healthcare practitioners for individual patients Regulated at a State/Territory level
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Risk based regulation of medicines Australia has a risk-based approach with a two-tiered system for the regulation of all medicines, including complementary medicines Lower risk medicines listed on the Australian Register of Therapeutic Goods AUSTL Higher risk medicines registered on the ARTG AUSTR
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Risk based approach
• Pre-market evaluation • Medicine focussed • May have restrictions
on access • Higher level claims • Identified by “AUST R”
number
RISK
Registered
Listed
• No restrictions on access
• Low and medium level claims
• May have restrictions: quantities, dosage form, route of admin, plant part, etc
• Enter ARTG via the Electronic Listing Facility (ELF)
• Sponsor makes certifications against requirements
• Evidence for claims monitored ‘post-market’
• Id. by “AUST L” number
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medicines - revival
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Determinants of Risk • Ingredients • Dosage form • Indications and claims • Significance of side effects • Effects of prolonged use or inappropriate self-medication
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Is it eligible for Listing? Eligibility requirements
Approved ingredients
Preparation not in SUSMP
Qty restrictions not exceeded
Not required to be sterile
Herbal ingredients meet definition of “herbal substance”
Indications do not refer to disease / condition in Appendix 6 of TGAC
Sponsor certifies medicine eligible for Listing
ELF validation can pick up some ‘ineligibility’
Listing
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Listed Medicines Regulatory Framework
Listed on ARTG • Streamlined online application & validation process
• Sponsor certify meets legislation requirements
• No premarket efficacy evaluation
Retail supply to Australian market
place
Compliance review
Unique Regulatory Framework
Evidence sourced from open literature
Regulatory framework consistent with low
risk medicines
Quick & easy market access
Pre-approved ingredients
Market share established
Fully compliant Non compliant
??? Cancelled from ARTG
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Post-listing regulatory activities Risk based regulatory approach includes: • desk-based audits of listed medicines • laboratory testing of products and ingredients • surveillance in the marketplace • monitoring of adverse reactions • recalls procedure • audit of manufacturing sites • controls for advertising
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Type of Compliance Reviews for LMs Investigations • Triage of complaints into highest
priority target review Target Reviews • Often triggered from complaint or
intelligence report • Specific information is reviewed to
address concerns • Comprehensive evidence reviews Random Reviews • Newly LMs are randomly selected • Standard set of information is
reviewed
Target Reviews (Narrow scope)
Random Reviews
(broad scope)
Investigations (triage)
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Compliance Review
Review
Evidence Claims / indications: relevance, quality
Labelling
Correct format
Presentation
Advisory statements
Manufacturing
Licence / valid clearance
Finished Product Specifications
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Listing Compliance Review Process
Medicine listed on ARTG
Compliance review Request for information (s31 of Act )
Assessment of information against relevant legislative
requirements
Direct cancellation
ss30(1C) or (1A)
Cancel medicine from ARTG
compliance issues identified
Propose to Cancel (P2C)
Address all non-compliance
issues of P2C Medicine remains
on ARTG
Cancellation ss30(2)
Cancel medicine from ARTG
Fully compliant Medicine remains
on ARTG
Sponsor review listing & address issues
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Does the indication match the evidence? • Scientific indications are supported by scientific evidence • Traditional indications are derived from a tradition of use
within a paradigm • Format of 2 types of indications are different on the
medicine label • According to the current Evidence Guidelines1
– Is the evidence relevant?
• Equivalent doses; plant part – Is it high quality evidence?
• Systematic reviews, methodological sound – Is it a balanced view?
• Positive evidence > equivocal/negative
1Guidelines for levels and kinds of evidence to support indications and claims (2011)
Incr
easi
ng q
ualit
y
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Traditional Use – Indications & Evidence • Evidence of Traditional Use:
– well-established tradition of use for its intended purpose >75 years and includes: how it has been used during that time the continuity of its use; and the geographical extent of its use.
• Example of traditional indication:
– Traditionally used in Western herbal medicine to relieve nasal congestion
• Sources include: – National formularies – materia medica – official pharmacopoeias; and – monographs
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Evidence guidelines
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Registered complementary medicines • Higher risk than listed medicines based on the ingredients and/or
therapeutic indications • identified on the label by ‘AUST R’ followed by a number • Medicines must be registered on ARTG, where they:
– Don’t solely comprise ingredients permitted for use in listed medicines
– Contain an ingredient subject to the conditions of Poisons Standard e.g. Pharmacist Only vitamins/minerals must be registered
– Are required to be sterile – Have indications that make higher level claims that are not allowed
in listed medicines • Registered complementary medicines may be subject to the conditions
of a Schedule of Poisons Standard 18
Registered complementary medicines • Pre-market evaluation is undertaken to establish quality, safety and
efficacy of the medicine prior to approval for entry on the ARTG • Data requirements and evaluation are consistent with other OTC or
prescription medicines • Evaluation includes determining whether the medicine complies with all
applicable legislative requirements • Application data typically follows scheme used in the Common
Technical Document (CTD), an internationally-agreed format for approval of new drugs adopted by TGA in 2004
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Registered Medicines – Safety & Efficacy Data Overview • Literature search strategy • History and pattern of human use • International regulatory status • Pharmacodynamics, pharmacokinetics, safety
pharmacology, drug interactions • Toxicology: acute, chronic/subchronic, genotoxicity,
carcinogenicity, reproductive & developmental etc. • Clinical trials • Adverse event reports in Australia and overseas
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Registered Medicines – Quality Data Overview • Structural formula of the ingredient or components • Physiochemical and other relevant properties • Manufacturing details • Characterisation of ingredient or components • Control of substance: specifications, analytical procedures,
batch certificate of analysis, justification of specifications • Reference standards • Stability data • Container/closure system
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The Challenge Managing industry innovation with consumer safety
Minimal regulatory burden
Industry Consumer
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Guidance material Recently updated
• Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
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Questions Subscribe to Updates: www.tga.gov.au/newsroom/subscribe.htm Information on reforms: www.tga.gov.au/industry/cm-reforms.htm
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