The regulation of complementary medicines Yasmin Mollah Assistant - - PowerPoint PPT Presentation

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

2

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

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

Risk based approach

• Pre-market evaluation
• Medicine focussed
• May have restrictions
• n 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

• f “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 9

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

• pen 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 12

Compliance Review

Review

Evidence Claims / indications: relevance, quality Labelling Correct format Presentation Advisory statements Manufacturing Licence / valid clearance Finished Product Specifications

13

Listing Compliance Review Process

Medicine listed

• n 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

• n ARTG

Cancellation ss30(2) Cancel medicine from ARTG Fully compliant Medicine remains

• n ARTG

Sponsor review listing & address issues

Capsig NSW - Complementary medicines - revival 14

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)

Increasing quality

15

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

Capsig NSW - Complementary medicines - revival 16

Evidence guidelines

Capsig NSW - Complementary medicines - revival 17

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
• f 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

19

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

20

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

21

The Challenge

Managing industry innovation with consumer safety

Minimal regulatory burden

Industry Consumer

22

Guidance material

Recently updated

• Australian Regulatory Guidelines

for Complementary Medicines (ARGCM)

23

Questions

Subscribe to Updates: www.tga.gov.au/newsroom/subscribe.htm Information on reforms: www.tga.gov.au/industry/cm-reforms.htm

Capsig NSW - Complementary medicines - revival 24