new zealand medicines and medical devices safety authority a business unit of the ministry of health
TRANSCRIPT
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New Zealand Medicines and Medical Devices Safety Authority
A business unit of the Ministry of Health
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National Health Committee
A regulators perspective on the
integration of complementary medicines
into the management of chronic diseases.
Dr Stewart S Jessamine
Principal Technical Specialist
Medsafe
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The Case For Regulation
Evidence based practice requires evidence of:– Safety – – Quality – Efficacy
Medicines are not items of ordinary commerce– Oversight by an expert authority is
necessary.
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Current Regulatory Controls
Assessed by Regulator Activities Medicines Dietary Supplements Safety of ingredients Yes No Quality in manufacture Yes No Effectiveness/claims Yes No (not permitted) Ministerial approval Yes No Dose Yes No Labelling Yes Yes Additives Yes Yes
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Balancing Expectations
Regulation
Industry Regulator
Consumers
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Shared Expectations
Products:• Safe• High Quality• Effective• Predictable• Accessible
Regulation:• Simple• Risk based• Cost efficient• Transparent• Equitable
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International Requirements
• WHO - support registration and quality controls for complementary medicines
• USA - DSHEA limits claims, introducing quality controls,proposing to introduce active regulation.
• Europe – increasing regulatory controls on complementary medicines, herbal and traditional medicines and adverse reactions monitoring.
• Australia – pre-market approval, standards, quality (GMP), claims limited by evidence, controls over advertising, adverse reactions monitoring
• Canada – new legislation, registration, quality (GMP), controls over claims, adverse reactions monitoring
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Risk AssessmentRisk identification:
• Intrinsic – risk arising from the ingrediants themselves e.g. aristolochia.
• Extrinsic – risk arising from the way goods are manufactured e.g. spiking with sildenafil.
• Inappropriate use - risk arising from misuse, abuse e.g. 1,4 butandiol, misinformed use, and inappropriate claims e.g. lyprinol.
Risk Management Strategy– Legislation introducing:
• Minimum quality standards• Ingredient safety requirements• Adverse reactions monitoring• Appropriate therapeutic claims
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Scope and Coverage of the Regulatory Scheme
• Manufacture, import, supply, promotion and export of therapeutic products in New Zealand and Australia
• Prescription medicines, non-prescription medicines, complementary medicines, medical devices and other therapeutic products
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Key Elements of the Regulatory Framework for
Medicines
• Compliance with standards
• Licensing of manufacturers
• Product licensing
• Post-market monitoring and surveillance
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Risk Classification for Medicines
Class I– Contain only ingredients from permitted
list; no scheduled medicines– Product not for prevention or treatment of a
serious disease– Excludes products required to be sterile
(e.g. injections, eye drops)
All other medicines are Class II medicines
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Licensing of Manufacturers
• Agency will license New Zealand and Australian manufacturers
• Manufacturers audited for compliance with manufacturing principles
• Licence issued subject to conditions• Annual fee and declarations to maintain
licence• Certain medicines or persons exempt
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Product LicensingFor Class I complementary medicines
– Simple, internet based application system– Relies on sponsor self-assessing product against
a set of requirements– No pre-market evaluation by agency– No delay to market entry
• For Class II complementary medicines– Sponsor submits application for evaluation by
agency– Data requirements depend on characteristics of
product
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Product Licensing (continued)
• Export-only PL available (internet-based application)
• Each PL has a unique identifier • Product licence document sets out particulars
of product and conditions subject to which licence is issued
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Product Licensing (continued)
• PL may be varied• PL may be revoked or suspended• Certain medicines exempt from PL
requirement• Separate PL for each separate product (some
grouping possible)
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Ingredients Permitted in Class I
Complementary Medicines
• New list at start-up of joint agency• List will include ingredients currently
permitted in Listable medicines in Australia, plus those added as a result of Permitted Ingredients List project
• Process for adding new ingredients to list
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Expert Advisory Committee on Complementary Medicines
• Appointed by Ministerial Council• Members chosen for their expertise• Provide advice to the Managing Director
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Post-market Monitoring and Surveillance
• Product testing programme• Adverse reactions monitoring• Complaints investigations• Recalls
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Fees and Charges
• Agency to operate on full cost recovery• Fees and charges prescribed in Rules• Fees and charges model is under
development• Consultation to occur on a set of proposals
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Review of Decisions
• Merits review– Internal review– Review by independent merits review
tribunal
• Judicial review– Existing judicial review arrangements
maintained– Review in one country or the other– Decision has effect in both countries
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Next Steps
• Exposure drafts of regulatory requirements
• Rules finalised after stakeholders consulted
• Bills passed 2005
• Treaty ratified
• Agency opens doors mid-2005
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Keeping up to date ……
• www.jtaproject.org
• Subscribe to Medsafe e-mail service
for news and site updates:
www.medsafe.govt.nz/regulatory