Presentation: The regulation of complementary ... 2015/03/25 آ  The regulation of complementary medicines

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  • 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

    Presenter Presentation Notes What is the Therapeutic Goods Administration?

    The Therapeutic Goods Administration, also known as the ‘TGA’, is a Division of the Australian Department of Health. It was established in 1989. The purpose of the TGA is to safeguard the health of the Australian public. The TGA does this by regulating therapeutic goods before they are available to the Australian public. This work is the ‘pre-market’ work of the TGA.

    Another important role of the TGA is to monitor and review therapeutic goods after they are available to the public. This is to make sure that therapeutic goods in Australia continue to be safe for use. This is the ‘post-market’ work of the TGA.

    Therapeutic goods include both medicines and medical devices. TGA also regulates biologicals.

  • 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

    2

    Presenter Presentation Notes As shown on the diagram, the TGA is divided into three sections. The National Manager, Professor John Skerritt, is the head of the TGA.

    The three different sections, or ‘groups’ of the TGA are: The Market Authorisation Group The Monitoring and Compliance Group and The Regulatory Support Group

    The Market Authorisation Group takes care of the pre-market space of therapeutic goods. That is, they evaluate and assess products before they are available to the Australian public.

    The Monitoring and Compliance group takes care of the post-market space. They make sure that products accessible to the Australian public are safe. They also make sure that therapeutic products comply with the law.

    The Regulatory Support Group provides corporate support to everyone at the TGA. They also deal with the business side of the TGA.

    The Office of Complementary Medicines, or OCM, is found within the Market Authorisation Group. The OCM is unique because it also monitors and reviews products after it becomes accessible to the Australian public. This is usually the role of the Monitoring and Compliance Group.

  • 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)

    3

    Presenter Presentation Notes Within the Market Authorisation Group, there are a number of different offices. Each office generally looks after a certain class of therapeutic goods.

    For example, The OMA is the Office of Medicines Authorisation. This office evaluates prescription medicines and over-the-counter medicines. The OCM oversees the regulation of complementary medicines in Australia. The ODA is the Office of Devices Authorisation. The ODA is in charge of medical devices. And the OSE is the Office of Scientific Evaluation. This office looks after toxicology, pharmaceutical chemistry and biological sciences, including blood and tissues products. The Office of Complementary Medicines contains four sections.

  • What are Complementary Medicines?

    Capsig NSW - Complementary medicines - revival

    4

  • 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

    5

  • 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

    6

    Presenter Presentation Notes Australia has a risk-based approach with a two tiered system for the regulation of all medicines, including complementary medicines. Medicines are either listed or registered on the Australian Register of Therapeutic Goods (ARTG), depending on the claims that are made bout the medicines, and the benefits and risks associated with using it. Lower risk medicines are listed medicines are include an “AUSTL” on the label. Higher risk medicines are registered medicines and include an “AUSTR” on the label.

  • 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

    Capsig NSW - Complementary

    medicines - revival

    7

  • Determinants of Risk • Ingredients • Dosage form • Indications and claims • Significance of side effects • Effects of prolonged use or inappropriate self-medication

    Capsig NSW - Complementary medicines - revival

    8

  • 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

    Capsig NSW - Complementary medicines - revival

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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

    Capsig NSW - Complementary medicines - revival

    10

  • 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

    11

  • 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)

    Capsig NSW - Complementary medicines - revival

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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

    13

    Presenter Presentation Notes Compliance Reviews

    Information reviewed by the TGA can generally be divided into three categories:

    Evidence Claims made about the product are compared to the evidence provided by the sponsor. Evid

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