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Navigating The Regulatory Maze. 16 th February 2011. Tim Adetona Voisin Consulting Life Sciences 3 rue des Longs Pres 92100 Boulogne France Tel: +33 1 41 31 83 02 email: [email protected] Innovative Healthcare Product Development & Regulatory Strategy. Expertise.

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16 th february 2011

Navigating The Regulatory Maze

16th February 2011

Tim Adetona

VoisinConsulting Life Sciences

3 rue des Longs Pres

92100 Boulogne France

Tel: +33 1 41 31 83 02

email: [email protected]


Anticipate, convince and participate in creating forthcoming regulations


  • New classes of productsat borderbetween or combining drugs, biologics, bioactives, medical devices, diagnostics, cosmetics:

  • Personalized & predictive medicine

  • Targeted therapies

One Multidisciplinary Team

+/- 70 connected men & women working as one multicultural, scientific & regulatory team

Ph.D, M.D, Pharm.D, M.Sc, Engineers

Multilingual: English, French, German, Spanish, Italian, Serbian, Hindi…

Our Connected Offices

Cambridge, MA - USA

[email protected]

Lausanne –Switzerland [email protected]

Paris & Rennes - France

[email protected]

[email protected]

Bangalore - India

[email protected]

[email protected]


[email protected]

Navigating the nutraceutical maze
Navigating The Nutraceutical Maze

  • The Nutraceutical Promise

  • Marketing Objectives

  • Historical Perspective & Current Status

    • Differing Classification Questions

    • Product Positioning Questions

  • Global Regulatory Frameworks

    • FSSAI Alignments

  • Universal Health Claim Considerations

  • Human Data Elements

  • Strategic Regulatory Advice

The nutraceutical promise
The Nutraceutical Promise

  • Community of supplementusers continue to drive growthimpressively

  • A 2008 BCC research positions global Nutraceuticalsat 7.4% growth

  • Projected to hit $176.6 billion by 2013

  • Herbalsupplements to 93 billion in 2015 (Global Industries Analysts)

  • Globalisation of Nutraceuticals has come to stay

  • Howeverincreasinggrowthtypicallyattractsincreasingregulation

    • High degree of consumer protection

    • Promotion of fairtrade, and

    • Not at the expense of productresearch & innovation

  • Hence, there are challenges inherentwith the growthpotentials

Marketing objectives
Marketing Objectives

  • Get products to the market in the shortest time possible

  • Optimally communicate products’ health benefit to consumers

  • Achieved within the appropriate regulatory regimen

  • Preferably, operate the same requirements globally!

  • Harmonizationfacilitates global trade, R&D, predictability

  • Pharmas have takenveryhugeharmonizationstepsthroughICH

  • Global marketdevelopmentsuccess relies on soundknowledge of extensive as well as emerginglegislativeframeworks

Historical perspectives status
Historical Perspectives & Status

  • National regulations used to be “local” in concept and application

  • Harmonized rules present opportunities for global brands

  • Regional harmonization are gradually evolving e.g. ASEAN: AFTA

  • Asia, LAM at various stages of development

  • EC, USA, Canada, Japan are “stand-alone” at the most

  • With “work in progress” in key aspects e.g. EU’s

    • substances other than Vits/Min;

    • certain aspects of PARNUTS;

    • Nutrient Profile being a basis for NHCR

  • Discrepancy exists globally with definition, classification & requirements

Differing classification questions
DifferingClassification Questions

  • Product designation

    • Food supplements, dietary Supplements, Vit/Min level,

    • PARNUTS, FOSHU, Medical Food,

    • Herbal Product, Botanical product,

    • Medicinal?, Nutrient?, Ingredient status?

    • Permmited List for Nutrients, Functional Food,

    • Probiotic, Prebiotic,

    • Novel?, Sports food,

    • Additive permitted, Excipients,

    • Nutricosmetics, Cosmeceuticals

  • Market authorization:

    • registration vs. notification,

    • duration of procedure,

    • Life Cycle Management impact

Product positioning questions
ProductPositioning Questions

  • Regulatory approach questions:

    • Harmonized procedure

    • National procedure

    • Duration & Stringency

  • Communicating product’s health benefit questions:

    • NHCR,

    • Generic Art.13(1), Art.13(5),

    • Art.14(a) & (b),

    • Qualified health claims,

    • SSA,

    • National rules,

    • NHPD requirements

  • Global brand packaging differences:

    • Label content presentation,

    • Minimum font size requirements,

    • Regional RDA,

    • Mandatory warnings,

    • Geographical regions (Australia, USA, FDA, EU, Canada, LAM, MEA)

Global regulatory frameworks
Global RegulatoryFrameworks

  • EU (EFSA, National Authorities)

    • NHCR 1924/2006

    • Nutrition claims/nutrient content

    • Art. 13 (1) & (5); Art. 14 (a) & (b)

    • PASSCLAIM criteria

  • USA (FDA)

    • Health Claims

      • NLEA 1990: Authorized Health Claims (SSA – Significant Scientific Agreement)

      • FDAMA 1997: Authoritative Statements by scientific bodies (not Food Supp)

      • CHI&BNI 2003: Qualified Health Claims (evidence not as strong as SSA)

    • Nutrient Claims: NLEA 1990 (similar to EU Nutrition claim)

    • Structure/Function Claims: DSHEA 1994 (FDA non pre-approveddisclaimer)

Global regulatory frameworks1
Global RegulatoryFrameworks

  • Japan

    • Foods for special health Use (FOSHU) established from 1991

    • Includes processed food products, tablets & capsule forms

    • Dietary ingredients with beneficial physiological functions in humans

    • Maintain/promote health; improve health conditions

    • Similar to other structure/function claims in USA or other functions in Codex Alimentarius

    • Requires validation of quality, efficacy and safety

    • Disease risk reduction possible (Ca & osteoporosis; Fä & neural tube defects)

    • Since 2005, Qualified FOSHU claims (a la FDA) also possible

  • ASEAN (Association of South East Asian Nations)

    • Progressive harmonization at the instance of ASEAN Free Trade Agreement (AFTA, 1967)

    • Definition of Food supplement

    • Supplements diet to enhance or improve the health function of the human body

    • Contains one or more of vitamins, minerals, amino acids, enzymes, probiotics, bioactives

    • Health claim evidence increases from general/nutritional; functional; disease risk reduction

Global regulatory frameworks2
Global RegulatoryFrameworks

  • Korea (KFDA)

    • Health functional food (HFF) includes

    • Any form of foods, food supplements with functional ingredients useful to the body

    • Established in 2002, regulation recognizes Generic HFF (with spec & standards in HFF code)

    • And product-specific HFF (requires pre-market registration/approval of specific ingredients)

    • 3 types of claims: nutrient function; other function; reduction of disease (Codex Alimentarius)

    • Other functions. convincing; probable; or insufficient

  • China (SFDA)

    • Functional food: has special health functions or is able to supply vitamins or minerals

    • Suitable for consumption by special groups of people and regulates human body functions

    • Toxicity, functionality, stability and hygiene tests are required for pre-market approval

    • 27 categories of product-specific health claims (function and reduction of disease risk)

    • Historical/traditional & present-day use data to be provided on herbs

Global regulatory frameworks3
Global RegulatoryFrameworks

  • Latin America

    • No harmonized provisions on health claims and substantiation

    • National legislations to be considered separately (Argentina, Brazil, Chile, Colombia, Mexico)

  • Argentina

    • No provisions for health claims in the food regulation

    • Claims on diseases and therapeutic conditions are prohibited

    • Ads can describe physiological effect of nutrients (vitamins & minerals) on healthy people

  • Brazil

    • Food and food supplement labeling is regulated

    • Positive list on functional and health claims approved in 2008 for 18 nutrients & ingredients

    • Evidence to support food claims: nutritional, physiological, toxicological trials on animals; biochemical, epidemiological, clinical trials; proof of efficacy through traditional use in the population; and scientific literature

  • Mexico

    • Guidelines on nutrition and health claims are based on the Codex Alimentarius

Fssai alignment
FSSAI Alignment

  • Food Safety and Standards Authorities of India (FSSAI)

  • Traditionalmedicines not part of Nutraceuticals

    • USA’sDietarySupplementsincludetraditional and herbalproducts

    • Canada’s Natural HealthProductsincludetraditional and herbalproducts

    • EU’s Food Supplements (TraditionalHerbalMedicinesseparatelyregulated)

    • Japan’s FOSHU (Traditional & HerbalMedicines not part of definition for dietarysupp)

  • FSSA 2006 listsingredients (& properties) thatcanbeNutraceuticals

  • Foods for SpecialDietary Uses

    • May contain plants/botanicals, vit/min, substances of animal origin & dietarysupps

    • Similar to EU’s Food supplements

  • ReferencesIndiaRDA

    • Ca|Vit. D: [EU: 800mg|200IU]; [US/CAN: 1000+mg|600IU]; [Ind: 400/600mg|400IU]

Universal health claim c onsiderations
UniversalHealth Claim Considerations

  • Clarify the relationship between the food/constituent and health effect

  • Clarify valid measurements for the food/constituent and the health effect

  • Rank all the pertinent scientific data

  • Verify the quality of each supportive scientific data

  • Interpret each pertinent study

  • Consider the totality and the weighing of available scientific evidence

  • Best substantiated by well-designed human intervention studies.

  • Demonstrates association between food/constituent and health effect

  • Observational studies are not typically accepted as strong evidence

Human data elements
Human Data Elements

  • Sufficient characterization of the food component for the claimed effect

  • Study group is representative of the target population

  • The use of appropriate controls

  • Adequate duration of exposure in view of the intended effect

  • Sufficient characterization of the study group’s background diet and lifestyle

  • Amount of food/component is consistent with intended pattern of consumption

  • Compliance monitoring & test of hypothesis

  • Use of appropriate markers instead of difficult-to-measure true endpoints

  • Use of biologically valid biomarkers

Strategic regulatory advice
Strategic Regulatory Advice

  • Determine ideal classification (e.g. EU Ingredient Decision Tree)

  • Become familiar with pertinent regulatory requirement

  • Determine optimal regulatory strategy

  • Investigate possible alternative market authorization route

  • Review every aspects of the product and pack presentation

  • Analyze and validate ingredients & formulas in different markets

  • Conduct data gap analysis for registration/notification & claims

  • Verify compliant product labeling as per market

  • Design and compile technical dossier as per chosen strategy

More regulatory advice
More Regulatory Advice

  • Deploy strategic planning for changing regulatory environment

  • Invest time & effort behind marketing claim proposition

  • Investigate appropriate regulatory strategy for claim positioning

  • Ensure protocol design & study data supports NHCR, HC, QHC, SSA …

  • Identify & bridge gaps in claim support data

  • Consider compromise claims wordings as interim strategy

  • Conduct comprehensive products’ regulatory market readiness

  • Validate your findings with experienced Experts

  • Develop & market product on the basis of expert-validated outputs

    • Plan for Adverse Events Reporting/Vigilance reporting (US, France…)

Lest we forget
Lest We Forget

  • The Nutraceuticals market holds much promise

  • And directly affected by apparent regulatory classification constraints

  • Passing a health claim application presents another hurdle

  • Within these challenges are opportunities, and solutions remains in:

    • Strategic consideration of life-cycle and regulatory alternatives,

    • Correct application of knowledge of local/national/regionalpeculiarities

    • Rigorous gap analysis of regulatory market readiness plans

    • Constructive scientific data positioning and justification

  • The obvious may not necessarily be the only or optimal pathway

  • The seeming difficulty may not be a “show-stopper”

  • To every problem is a solution! We only need to find the right one.

Thank you
Thank You

Tim Adetona

Voisin Consulting

3 rue des Longs Pres

92100 Boulogne France

Tel: +33 1 41 31 83 02

Mob: +41 7 95 49 38 12

email: [email protected]