CPhI Capsules as medical devices (full presentation)

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All you need to know about the incredible opportunities offered by Medical Devices for Consumer Health

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CPhI Capsules as medical devices (full presentation)

  1. 1. Capsules as Medical Devices Maikel Hendriks Partner Progressare CPhI October 2010 STRICTLY CONFIDENTIAL
  2. 2. Content Health / Implement Implement Notification Audit Surveillance Requirements Medical Claims Quality System Technical File (Pre Market) Notified Body (Post Market) STRICTLY CONFIDENTIAL
  3. 3. Health Claims HEALTH / MEDICAL CLAIMS STRICTLY CONFIDENTIAL
  4. 4. Health Medical Claims “Everything is allowed, Proof IT!” STRICTLY CONFIDENTIAL
  5. 5. Health Medical Claims “Globalising Health Claims” FOOD COS MDD PHARMA STRICTLY CONFIDENTIAL
  6. 6. Health Medical Claims Category Europe Food supplements 1924/2006/EC Products on the market must New EU regulations make medical claims on food supplements possible. comply by 19 JAN 2010 Definition: ‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its Evaluation < June 2011 constituents and health; Claim opinions < End 2011 Quality System: Claim indication: attends, support, maintains, keeps, optimizes, provides, safes, contributes HACCP Claims not allowed: cure, treats, prevents Cosmetics 76/768/EC Technical data: Definition: A “cosmetic product” shall mean any substance or preparation intended to be placed in contact with the various external parts of the Product information package human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with Quality System: a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them ISO-22716:2007 or keeping them in good condition. Claimsindication: cleaning, perfuming, change appearance, correcting body odors, conditioning Claims not allowed: cure, treats, prevents Medical Devices (Over-The-Counter) 93/42/EC + 2004/47/ec Product Data: “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, Technical construction File together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic Quality System: purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: ISO-13485:2008 • diagnosis, prevention, monitoring, treatment or alleviation of disease, • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, Manufacturers must comply by 21 • investigation, replacement or modification of the anatomy or of a physiological process, MAR 2010 • control of conception, and which does not achieve its principal Claims indication: attends, support, maintains, keeps, optimizes, provides, safes, contributes, treats, prevents Claims not allowed: cure Pharmaceutical 2001/83 EC Product Data: Definition: Medicinal product any substance or combination of substances presented for treating or preventing disease in human beings. Any eCommon Technical Dossier substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, Quality System: correcting or modifying physiological functions in human beings is likewise considered a medicinal product. GMP standard Claims indication: cure, treats, prevents Claims not allowed: None Cosmeceuticals: cosmetic products that are claimed, primarily by those within the cosmetic industry, to have drug-like benefits. •Examples of products typically labeled as cosmeceuticals include anti-aging creams and moisturizers. The word is a portmanteau of the words "cosmetic" and "pharmaceutical“. STRICTLY CONFIDENTIAL
  7. 7. REQUIREMENTS STRICTLY CONFIDENTIAL
  8. 8. Requirements CE-markering “Free Movement of Goods” STRICTLY CONFIDENTIAL
  9. 9. Requirements CE-mark Jaar 1987 20 Directives 1994 Blue Guidance 1995 Effective MDD 93/42/ec 1998 Transfer CE mandatory 21 maart Clinical Evaluation 2010 2007/47/ec STRICTLY CONFIDENTIAL
  10. 10. Requirements Medical Device definition (93/42/ec + 2007/47/ec) “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: • diagnosis, prevention, monitoring, treatment or alleviation of disease, • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, • investigation, replacement or modification of the anatomy or of a physiological process, • control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means STRICTLY CONFIDENTIAL
  11. 11. Requirements What is a medical device ? TEST STRICTLY CONFIDENTIAL
  12. 12. Requirements STRICTLY CONFIDENTIAL
  13. 13. Requirements STRICTLY CONFIDENTIAL
  14. 14. Requirements STRICTLY CONFIDENTIAL
  15. 15. Requirements STRICTLY CONFIDENTIAL
  16. 16. Requirements STRICTLY CONFIDENTIAL
  17. 17. Requirements Classification Matrix, Annex IX 93/42/ec + 2007/47/ec Annex IX of the Medical Device Directive describes the classification rules. The manufacturer shall determine the conformity assessment route for product registration based upon this classification. A product will always be placed in the highest applicable rule. Class I; outside body or through natural body openings, < 60 minutes min Class IIa; Treats and prevents infections, breached skin, wounds < 30 days Class IIb; pacemakers, monitoring equipment, wounds > 30 days Class III; combination medical device with medicines (or animal tissue) Market authorization: Class I: Manufacturer; Class IIab: Manufacturer + Notified Body (can also be the manufacturer if QMS complies with Annex II); Class III: Manufacturer + Notified Body + Medicine Board STRICTLY CONFIDENTIAL
  18. 18. Notification Competent Authority Class I EC declaration of conformity (Annex VII) Measuring Sterile Notified Body Full quality assurance (Annex II) EC verification EC declaration (Annex IV) of conformity Class IIa (Annex VII) Manufacturer’s option Production quality Manufacturer’s option assurance (Annex V) EC type- ABC Product class Class II Class IIb examination Product quality (Annex III) assurance (Annex VI) Full quality assurance (Annex II) ABC Notified Body + Medicine Board Manufacturer’s option EC design examination EC verification Manufacturer’s (Annex II, 4) (Annex IV) Class III option EC type- Production examination quality ABC (Annex III) assurance (Annex V)
  19. 19. Requirements SCOPE REQUIREMENTS MAINTENANCE SURVEILLANCE Supplier / contractor Regulations Technical CE-declaration Auditing Construction File Classification ? Manufacturer Post Market Quality Manual Surveillance Essential ISO Certificate Requirements Distributor STRICTLY CONFIDENTIAL
  20. 20. Appllying the Regulations Product Lifecycle START Requirements Definitions Classification Intended use Design input / Essential Requirements specifications Quality System STED (Technical dossier) Design Design / Risk evaluation Auditing – Internal & External Certification Technical data Quality System & Risk Management Design Essential Requirements verification Scope Full Quality System Scope product Lifecycle Labeling Pilot Quality System / GMP production Quality System Risk evaluation Validation Process validation Clinical Evaluation Conformity Assessment Quality System / GMP Production Route Notification / License Placed on the Market Post Market Surveillance Quality System Service Results & vigilance Surveillance Product Lifecycle END
  21. 21. Notification Competent Authority Class I EC declaration of conformity (Annex VII) Measuring Sterile Notified Body Full quality assurance (Annex II) EC verification EC declaration (Annex IV) of conformity Class IIa (Annex VII) Manufacturer’s option Production quality Manufacturer’s option assurance (Annex V) EC type- ABC Product class Class II Class IIb examination Product quality (Annex III) assurance (Annex VI) Full quality assurance (Annex II) ABC Notified Body + Medicine Authority Manufacturer’s option EC design examination EC verification Manufacturer’s (Annex II, 4) (Annex IV) Class III option EC type- Production examination quality ABC (Annex III) assurance (Annex V)
  22. 22. Parties involved BIG Brother is ..... watching YOU! STRICTLY CONFIDENTIAL
  23. 23. 3. Parties involved Farmatec Competent authority DEKRA IGZ MDD Notification class I MDD Notified Ministry of Body Health VWS BSI Verify class IIab and III MDD Policies / surveillance Audit Technical Files Free of Sales Certificates Audit Quality System Manufacturer CBG KOAGKAG Medicine Health Claim Authority authority Verify drug substance class III MDD Verify Health Claim Review Borderline products STRICTLY CONFIDENTIAL
  24. 24. Marketing Authorisation > EU Mutual Recognition Australia Singapore Hong Kong Malaisia South-Africa Canada (+) India (+) 25 STRICTLY CONFIDENTIAL
  25. 25. MARKET CHANGE NEW CATEGORY OTC Today 94 % 6% Source IMS Borderline 2015 85 % 3 30 % - Stronger regulations + New innovations - Movement Claim regulations + Less regulations - Homeopathic / herbal drugs regulations + BIG Marketing advantage - Missing eCTD + Nobody knows + CE = EU registration + New brands - Clinical Data claims - Nobo’s are stupid Pharmaceuticals - Inspectorates are unexperienced Medical Devices - Competition crap
  26. 26. MARKETING ADVANTAGE Less limitations in Marketing Statements (pair of glasses) Pricing stunts No requirements to record ingredients Clean packaging Identical claims as pharma Due to physical effects, less risks on side effects Etc Etc
  27. 27. SALES ADVANTAGE Internet Pharmacies Supermarkets Reforms Wellness Queensday – on the street (NL only) Everywhere
  28. 28. Capsule Developments Pellets in Licaps® Pellet in Cap in Licaps® Cap in Licaps® Licaps® Simethicone Soft Capsules Tablets Time STRICTLY CONFIDENTIAL
  29. 29. SUMMARY User Perspective: Health claim identical to Pharma < side effects Distributor / manufacturer: > distribution points > marketing advantage > less regulations IP: > patent applications > protection NEW as a MEDICAL DEVICE
  30. 30. 3. Contact us Progressare B.V. Veembroederhof 96 1019HC Amsterdam +31.20.3456363 Diane Bond Capsules as Medical Devices STRICTLY CONFIDENTIAL

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