Presentation: The regulation of complementary …...2015/03/25 · The regulation of complementary medicines Yasmin Mollah Assistant Director, Listing Operations Angeliza Querubin

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

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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)

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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

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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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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

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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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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. Evidence is assessed for its quality and relevance to the product. Labelling Product labels are reviewed to ensure that they comply with Therapeutic Goods Order 69 (TGO 69)– General requirements for labels for medicines. Manufacturing TGA will check to ensure that manufacturing documents comply with the relevant standards.

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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Presenter

Presentation Notes

When regulating complementary medicines, the OCM must balance industry’s needs with consumer safety. As shown on the slide, it is a balancing act between making products available whilst making sure that they are safe and of high quality.

Guidance material Recently updated

• Australian Regulatory Guidelines for Complementary Medicines (ARGCM)

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Presenter

Presentation Notes

The OCM has developed some guidance materials to help the industry understand the complementary medicines regulatory framework. We have recently updated the Australian Regulatory Guidelines for Complementary Medicines (ARGCM). This is our main guidance document. The Guidelines on the Evidence Required to Support Indications and Claims for Listed Complementary Medicines is another important document for industry.

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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Presentation: The regulation of complementary …...2015/03/25 · The regulation of complementary medicines Yasmin Mollah Assistant Director, Listing Operations Angeliza Querubin

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