Drug registration in Argentina


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My slides for the Regulatory Affairs in Emerging Markets Informa Conference in Berlin, October 2012

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  • we have got cofeprice gmp for our products. we would like to know the list of countries to register our products by using our gmp. can you advise
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  • Como se organiza ANMAT, dondequeda, organigrama, de quiendepende, cuando se formo, como se maneja
  • Como se organiza ANMAT, dondequeda, organigrama, de quiendepende, cuando se formo, como se maneja
  • Como se organiza ANMAT, dondequeda, organigrama, de quiendepende, cuando se formo, como se maneja
  • Drug registration in Argentina

    1. 1. María Inés GuaiaOctober 2012 - Berlin
    2. 2. Argentina – an emerging economy $435.6 billion GDP Services 60% #27 World #3 Latin America Industry 30% 8.8% annual growth rate Agriculture 10% #12 World #1 Latin America 40 million people 13 million in Buenos Aires and surroundings 30% below poverty line
    3. 3. HealthCare and Pharma in Argentina Pharma industry revenue: about8.5% of GDP in HealthCare $4,000 million / year Voluntary + Voluntary Social More than half of the market is taken by local insurance security pharmaceutical companies 9% 4%HealthCare Nervous System 15.9system Cardiovascular system 14.2 Digestive system 13.8 No coverage Systemic antiinfectious 11.2 38% Antineoplasic and Social 11.0 inmunomodulators Security 48% Muscle-skeleton aparatus 7.7 %
    4. 4. National Regulatory Authority of Regional Reference (PAHO/WHO) The drug agency in Argentina National Administration of Drugs, Food and Medical Technology National Institute Direction of Drug Direction of Planning and Institutional Relations of Medicines Product Evaluation (INAME)Control of Clinical evaluation Direction for Coordinationsites, processes, activities, technologie and Administrations:manufacturing, importation, fractioning, marketing Direction of National Institute of Direction of Legal Affairs Medical Technology Food
    5. 5. Drug registration in Argentina Decree 150/1992 and modifications Lists of countries by sanitary trust levelANNEX I USA France ANNEX II Australia ChinaHigh Sanitary Japan United Mexico LuxembourgSurveillance Kingdom Brazil Norway Sweden Netherlands Cuba New Zealand Switzerland Belgium Chile Israel Denmark Finland Canada Spain Hungary Austria Italy Ireland Germany
    6. 6. Drug registration in Argentina • Product information - name, formula,‘Article 3’ products pharmaceutical form, pharmacologic classification, marketing condition  DPs manufactured in Argentina or • Technical information - testing an Annex II country, similar to DPs standard, specifications, shelf life, already registered in Argentina. manufacturing method, pharmaceutical equivalence evidence  DPs manufactured in Argentina, with marketing authorization in an • Labeling texts (packaging and leaflets) Annex I country, even if ‘novel’*. • If manufactured in an Annex II country: CPPTimeline for of originapproval: about12 months * ‘Novel’ products: there are no similar products registered in Argentina • GMP from Annex I country or Argentina
    7. 7. Drug registration in Argentina‘Article 4’ products • CPP from Annex I country –  DPs with marketing authorization Marketed status in at least one Annex I country. • Labeling texts (packaging and leaflets) Timeline for approval: • Technical information - only about 10 upon authority request months
    8. 8. Drug registration in Argentina = ‘Article 3’ DPs • Product information‘Article 5’ products • Technical information  ‘Novel’* DPs manufactured in Argentina. • Labeling texts  ‘Novel’* DPs manufactured in an Annex II country. • If manufactured in an Annex II country: CPP of origin  DPs manufactured in a non-Annex I, non- Annex II country, and not authorized in • GMP from Annex I country or Argentina any Annex I country. plus Timeline for approval: not less than 3 years Safety and efficacy data
    9. 9. Renewal of certificate Every 5 years Documents (within 30 days prior to • Written request certificate expiration date) • Sworn statement – marketed/non marketed status • Evidence of marketingRelatively simple procedure • Certified copy of original certificate • Copy of last approved labeling texts
    10. 10. • • Local manufacturing Importation of drugs Local QC ‘First Batch Verification’• New product registration Submit form , manufacturing/QC schedule,• New concentration of technical information, pay fee biologic or small- therapeutic-window APIs ANMAT inspects ANMAT doesn’t inspect• New pharmaceutical form Send• Marketing authorization manufacturing/QC transfer documents Positive outcome Marketing Authorization
    11. 11. Variations of regulatory impactExamples:• Change of excipients• Change of manufacturer or Submit documents manufacturer’s name (only for DP) (very variable requirements)• Change in labeling texts – leaflets and packaging – including new indications Wait for approval• Shelf life extension• Change of marketing condition• Marketing authorization transfer• New primary packaging material
    12. 12. GMP inspections from ANMAT Application for inspection :When? documentsFor DP manufacturing sites when • Written requestnot in Annex I country, and without • Copy of ANMAT authorization to requestorcertificate from Annex I country. • Information on manufacturer/s • Site Master File• DP specific • Site authorization from HA in country in which it is.• Agreement with MERCOSUR countries • List of pharmaceutical forms manufactured in (e.g. ANVISA) site • List of DS manipulated in site • List of pharmaceutical forms by DS to import • Information and documents on third parties involved in manufacturing or control • Fees
    13. 13. New OTC labeling regulations Study: Patients hadof PILs interpreting the content trouble Information in question format February 2012 What is…? What is … used for? What warnings are required before/duringnew definitions and the use of…? How should I use…? What should I do if…?guidelines for labeling texts in leaflets andpackaging of all OTC drug products Illustrations may be added for better understanding• 2 years for submitting updated texts Only information relevant to• Immediate application for new registrations, variations and change of marketing condition the patient in layman’s terms
    14. 14. Official and unofficial import restrictions 2010 - 2012Drug products: ‘Automatic Authorization’… ISSUES - Implementation – delays Anticipated SwornFebruary 2012 - Commercial balance evaluation - Similar products manufacturedStatement for Importation locallyform to be submitted electronically before placing purchase order Less flexibility for the industryThree signatures before validation: Consumers associations• Federal Administration of Public Income (AFIP) – 72 h Pharmacists associations• Secretary of Domestic Trade• ANMAT up to 10 days Shortage of products
    15. 15. Orphan Drugs • Low frequency disorders (<1/2000) • Severe diseases (risk of incapacity or death) New Orphan Drug Regulation • Complete information of (at least) earlyPreviously: only special process for phases of clinical research (preclinicalimportation of drugs for compassionate use and phases I and/or II) – adapted trialsVery recently! August 2012 regulation • Evidence of orphan status ‘underfor registration of drugs • Plan of efficacy, efficiency and safety monitoring (patient register,special conditions’ • prescription/distribution scheme) Periodic reports Definitions • Intensive pharmacovigilance Requisites • Informed consent Creation of special committee of • Labeling: ‘AUTHORIZED UNDER evaluation SPECIAL CONDITIONS’
    16. 16. ANMAT ‘Public Opinion’ space Projects for new regulations Proposed textFood, Household Products, Cosmetics, Medical Devices, Drugs, Dietary Supplements, Others Feedback form Open for the general public to participate www.opinion_publica.anmat.gov.ar
    17. 17. eSubmissions: step by step2010: ‘depaperization’ projectGoals: better service – efficient administration – lower costs – greatertransparency Currently:First steps: • Clinical studies submissions• Electronic payment • Importation authorization requests for• Digital signature dietary supplements and medical devices • Submissions for registration of cosmetics
    18. 18. • Verónica Casaro • My Bayer GRA Berlin colleaguesAnd the rest of my Bayer Argentina colleagues: • Austin Keeble• Valeria Wilberger • Rafaela Zunini (my favorite• José Luis Role • Fernanda Balbi proofreader)• María Inés Pérez • Silvia Fabrizio• María Cecilia Díaz • Panchi Domínguez • Verónica Macías http://niniguaia.wordpress.com/