Pharma Regulatory Affairs in Argentina 2013
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  • upper middle-income economyServices includes well-developed social, corporate, financial, insurance, real estate, transport, communication services, and tourism.industrial production is highly diversified in Argentina: Leading are: Food processing and beverages; motor vehicles and auto parts; refinery products, biodiesel; chemicals and pharmaceuticals; steel and aluminum; industrial and farm machinery; electronics and home appliances. Agriculture: mainly meat, cereals and other grains
  • Drug registration in Argentina is regulated by Decree 150/1992 and posterior modifications. To understand which procedure should be followed at the time of submitting for drug registration in Argentina, the countries in which the drug product of interest is manufactured and marketed should be taken into consideration. ANMAT made for this purpose two list of countries, based on the level of sanitary surveillance, called Annex I and Annex II. (these lists are annexes to the drug registration decree)The different registration cases are described in the 150/1992 Decree, which classify products in three categories based on the countries in which they are manufactured and/or commercialized. Each category is described in a separate article of this Decree.
  • ‘Article 3′ productsApplies to:Drug products manufactured in Argentina or in an Annex II country, when there is a similar drug product already registered in Argentina.Drug products manufactured in Argentina, with marketing authorization in any Annex I country, even if there are no similar products registered in Argentina.Summary of documents required for submission:Product information: name, formula, pharmaceutical form, pharmacologic classification, marketing condition.Technical information: testing standard, specifications, shelf life, manufacturing method, pharmaceutical equivalence evidence.Labeling texts (packaging and leaflets)If manufactured in an Annex II country: CPP of originGMP certificate from Annex I country or ArgentinaTimeline for approval: about 12 months
  • ‘Article 4′ productsApplies for:Drug products with marketing authorization in at least one Annex I country.ANMAT relies heavily in high surveillance health authorities (defined as those of Annex I countries) so the procedure for registering drugs that have already been approved and are currently being marketed in those countries is the simplest and generally quicker. The CPP from an Annex I country, stating the marketed status, is the most important document of the submission. Technical information might even not be requested at all.Summary of documents required for submission:CPP from Annex I country – Marketed statusLabeling texts (packaging and leaflets)Technical information: to be submitted only upon authority requestTimeline for approval: about 10 months
  • ‘Article 5′ productsApplies for:Drug products manufactured in Argentina, when there are no similar products already registered in Argentina.Drug products manufactured in an Annex II country and not marketed in any Annex I country, when there are no similar products already registered in Argentina.Drug products manufactured in a non-Annex I, non-Annex II country, and not marketed in any Annex I country.Summary of documents required for submission:Product information: name, formula, pharmaceutical form, pharmacologic classification, marketing condition.Technical information: testing standard, specifications, shelf life, manufacturing method, pharmaceutical equivalence evidence.Labeling texts (packaging and leaflets)If manufactured in an Annex II country: CPP of originGMP certificate from Annex I country or Argentina (the same than for Article 3)Safety and efficacy evidence (preclinical and clinical studies)Timeline for approval: not less than 3 yearsThe strategy is generally to wait for approval in an annex I country in order to go for the Article 4 procedure
  • ‘Article 5′ productsApplies for:Drug products manufactured in Argentina, when there are no similar products already registered in Argentina.Drug products manufactured in an Annex II country and not marketed in any Annex I country, when there are no similar products already registered in Argentina.Drug products manufactured in a non-Annex I, non-Annex II country, and not marketed in any Annex I country.Summary of documents required for submission:Product information: name, formula, pharmaceutical form, pharmacologic classification, marketing condition.Technical information: testing standard, specifications, shelf life, manufacturing method, pharmaceutical equivalence evidence.Labeling texts (packaging and leaflets)If manufactured in an Annex II country: CPP of originGMP certificate from Annex I country or Argentina (the same than for Article 3)Safety and efficacy evidence (preclinical and clinical studies)Timeline for approval: not less than 3 yearsThe strategy is generally to wait for approval in an annex I country in order to go for the Article 4 procedure
  • Both when products are manufactured locally and when they are imported from other countries, there has to be quality check in Argentina for local product release. The quality control duties can be performed by the manufacturing or importing company, or by an authorized third party.For the cases of new product registration,new concentration of biologic or small-therapeutic-window APIs,new pharmaceutical form or marketing authorization transfera procedure called first batch verification will take place.Before the release of the first batch for commercial purposes, the manufacturing or importing company has to request the first batch verification, by submitting the corresponding form, the manufacturing and/or quality control schedule, the relavant technical information and by paying a fee.ANMAT will then either physically inspect the manufacturing and/or control processes in the dates provided in the schedule, or review the manufacturing and/or control records afterwards as a ‘documental verification’ if it decides not to inspect.Upon a positive outcome, a marketing authorization will be granted
  • In Argentina, once granted the registration by ANMAT, product certificates expire in 5 years. The registration renewal procedure is relatively very simple, almost an entirely administrative procedure. The request for renewal has to be submitted within 30 days prior to the certificate expiration date, and should include the following documents:Written requestSworn statement – marketed/non marketed statusEvidence of marketingCertified copy of original certificateCopy of last approved labeling texts
  • Important: the product classification according to the article 3, 4 or 5 criteria: if it chages, if it is maintained.Change of excipientsVariation formNotary-authenticated copy of certificateFeeSworn statement declaring that the requested variation won’t change the finished product stability, the analytical methods, nor require any change in the manufacturing process.Change of manufacturer (only for finished product)If the change is from a manufacturer in Argentina to another manufacturer in ArgentinaCopy of authorization certificate of the new manufacturerCopy of authorization certificate of the solicitorVariation formNotary-authenticated copy of certificateManufacturing agreement signed by technical directors and legal representatives; signatures must be certified.FeeIf the change of manufacturer involves a manufacturing plant outside Argentina (process must be filed under the “new alternative origin country” case)- If the change supposes that a registered article 3, 4 or 5 product becomes an article 5 product:FormSworn Statement declaring that labeling text will be the same that already authorizedEvidence of commercialization of product made in new origin country in at least one Annex I countryAuthenticated copy of original certificateFee- If the change supposes that a registered article 3 or 5 product becomes an article 3 product:FormSworn Statement declaring that labeling text will be the same that already authorizedSworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.Evidence of commercialization of product made in new origin country in new origin countryApproval of manufacturing site in new origin countryAuthenticated copy of original certificateFee- If the change supposes that a registered article 4 product becomes an article 3 or 5 product:FormSworn Statement declaring that labeling text will be the same that already authorizedManufacturing methodControl methodsStability studiesEvidence of commercialization of product made in new origin country in new origin countryApproval of manufacturing site in new origin countryAuthenticated copy of original certificateFee- If the change supposes that a registered article 5 product becomes an article 3 or 5 product:FormSworn Statement declaring that labeling text will be the same that already authorizedSworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.Authenticated copy of original certificateFee- If the change supposes that a registered imported article 3 or 5 product will be manufactured in Argentina:FormSworn Statement declaring that labeling text will be the same that already authorizedSworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.Authenticated copy of original certificateAuthenticated copy of authorization certificate for the manufacturing site.Fee- If the change supposes that a registered imported article 4 product will be manufactured in Argentina:FormSworn Statement declaring that labeling text will be the same that already authorizedManufacturing methodControl methodsStability studiesAuthenticated copy of original certificateFee- If the change supposes that a registered product manufactured in Argentina becomes an article 4 product:FormSworn Statement declaring that labeling text will be the same that already authorizedEvidence of commercialization of product made in new origin country in at least one Annex I countryAuthenticated copy of importing licenseAuthenticated copy of original certificateFee- If the change supposes that a registered product manufactured in Argentina becomes an article 3 or 4 product:FormSworn Statement declaring that labeling text will be the same that already authorizedSworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.Approval of manufacturing site in new origin countryAuthenticated copy of importing licenseAuthenticated copy of original certificateFeeChange of corporate name of manufacturer (only for finished products)Legalized copy of representation power from headquarters to local affiliateLegalized copy of letter for the legal representative of the new corporate entity informing the new structure.Legalized copy of product certificate.Variation formFeeLabeling changesIf the change is in one or some of the following sections: Warnings, Contraindications, Adverse Reactions, Precautions, Interactions or Overdose:DJMP form (Labeling Modification Sworn Statement)Notary-authenticated copy of certificateCopy of last approved labeling textsNew labeling texts with track change marksThree copies of new labeling textsSworn statementIf the change is in an item different than the mentioned above, then a fee must be payed and the requested documents are the following:Notary-authenticated copy of certificateJustification documentationCopy of last approved labeling textsNew labeling texts with track change marksThree copies of new labeling textsFeeIf the change includes a new indication:Notary-authenticated copy of certificateCopy of last approved labeling textsNew labeling texts with track change marksThree copies of new labeling textsEvidence of marketing in an Annex I country (with new indication)FeeShelf life extensionNotary-authenticated copy of certificateCertificate from origin country, specifying requested new shelf life (only if available, for imported products)Stability data - Representative chromatograms of the study might be requested.Finished product specifications and analytical methodsFeeChange of marketing conditionVariation formNotary-authenticated copy of certificateThree copies of new labeling textEvidence of marketing of a similar product marketed in Argentina or an Annex I country under the requested marketing condition.FeeMarketing authorization transferContract of certificate transfer signed by legal representatives and technical directors of both companies.Copy of authorization certificate of site and corresponding dispositionCopy of technical director dispositionsCopy of representation powers of legal representativesFilled format detailing product certificates affected by the changeLegalized copies of those certificatesDiskette containing the following information: drug product, drug substance, certificate, validity, pharmaceutical form, owner and representationVariation form for each certificateCopy of sworn statement of certificates of marketed productsFeeNew primary packaging materialVariation formNotary-authenticated copy of certificateStability dataFeeSworn statement declaring that the requested variation won’t affect the finished product shelf life, the analytical methods, nor require any change in the manufacturing process. 
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  • After a consumer study that revealed that patients had problems interpreting and understanding the information included in OTC drugs patient information leaflets, and the variety of content and format that these leaflets showed across brands and products, a new regulation has been created to standardize the information to the patient and present it in a way that would be easy to understand for everyone.These new regulations and guidelines have to be implemented within a period of two years for all registered products, and immediately for new registration, variation and change of marketing condition cases.General points:Information must be written in SpanishInformation must be clear and accesibleFont size and style must be easily readablePictograms, colors, and other visual aids might be included to ensure a correct use of the drug productConsultation with doctor and/or pharmacist must be encouragedSpecific points: the information must be presented, both on the leaflet and the packaging labeling texts, in a question-and-answer format. Only information relevant to the patient should be included, in layman’s terms.In the patient information leaflet:Brand nameGeneric namePharmaceutical formMarketing condition: OTCMade in…READ CAREFULLY THIS INFORMATION BEFORE USING THIS DRUG PRODUCTWHAT DOES (comercial name) CONTAIN? Quantity of API, per dosage unit or percentual. Qualitative list of excipients.ACTION/SWHAT IS (comercial name) USED FOR? Symptoms and uses.WHO CAN’T USE THIS DRUG PRODUCT? Include allergies, contraindications and other situations in which use of the product could be adverse.WHAT PRECAUTIONS SHOUD I TAKE BEFORE USING THIS DRUG PRODUCT? Include warnings and precautions, relevant current and past medical conditions. Include: if you are taking other medication, you are pregnant or breast-feeding, ask your doctor before using this product.WHAT PRECAUTIONS SHOULD I TAKE WHILE USING THIS DRUG PRODUCT? Include adverse reactions and interactions. Indicate visit to the doctor in the case symptoms get worse or not revert after certain time.HOW SHOULD I USE (comercial name)? Include dosage regime and administration method, period of treatment, what to do if a dose is omitted, dosage in children, maximum daily dose, detailed explanations on how to use the product, (may include graphic aids) special observations. (take with meals, etc.)PREPARATION INSTRUCTIONS AND STORAGE CONDITIONSWHAT SHOUD I DO IN CASE OF OVERDOSE, OR IF I TOOK MORE OF THE PRODUCT THAN NECESSARY? Call and intoxication center, or go to the closest medical care center. Include telephone numbers.DO YOU HAVE ANY QUESTIONS? Include “ANMAT Answers” number, and company customer care telephone number.KEEP OUT OF THE REACH OF CHILDRENAT ANY QUESTION CONTACT YOUR DOCTOR OR PHARMACISTStorage conditionMade in…Technical Director:Drug Product Authorized by the Ministry of HealthCertificate NumberDate of last authorized labeling text:Presentations:In the packaging labeling text:Brand nameGeneric name – dose/concentrationPharmaceutical formWHAT DOES (comercial name) CONTAIN? Quantity of API, per dosage unit or percentual. Qualitative list of excipients.ACTION/SWHAT IS (comercial name) USED FOR? Symptoms and usesHOW SHOULD I USE (comercial name)? Include dosage regime and administration method, period of treatment, what to do if a dose is omitted, dosage in children, maximum daily dose, detailed explanations on how to use the product, (may include graphic aids) special observations. (take with meals, etc.)DON’T USE THIS DRUG PRODUCT IF YOU…The marketed condition (over the counter) should be remarked. (bold font)Share this:
  • After a consumer study that revealed that patients had problems interpreting and understanding the information included in OTC drugs patient information leaflets, and the variety of content and format that these leaflets showed across brands and products, a new regulation has been created to standardize the information to the patient and present it in a way that would be easy to understand for everyone.These new regulations and guidelines have to be implemented within a period of two years for all registered products, and immediately for new registration, variation and change of marketing condition cases.General points:Information must be written in SpanishInformation must be clear and accesibleFont size and style must be easily readablePictograms, colors, and other visual aids might be included to ensure a correct use of the drug productConsultation with doctor and/or pharmacist must be encouragedSpecific points: the information must be presented, both on the leaflet and the packaging labeling texts, in a question-and-answer format. Only information relevant to the patient should be included, in layman’s terms.In the patient information leaflet:Brand nameGeneric namePharmaceutical formMarketing condition: OTCMade in…READ CAREFULLY THIS INFORMATION BEFORE USING THIS DRUG PRODUCTWHAT DOES (comercial name) CONTAIN? Quantity of API, per dosage unit or percentual. Qualitative list of excipients.ACTION/SWHAT IS (comercial name) USED FOR? Symptoms and uses.WHO CAN’T USE THIS DRUG PRODUCT? Include allergies, contraindications and other situations in which use of the product could be adverse.WHAT PRECAUTIONS SHOUD I TAKE BEFORE USING THIS DRUG PRODUCT? Include warnings and precautions, relevant current and past medical conditions. Include: if you are taking other medication, you are pregnant or breast-feeding, ask your doctor before using this product.WHAT PRECAUTIONS SHOULD I TAKE WHILE USING THIS DRUG PRODUCT? Include adverse reactions and interactions. Indicate visit to the doctor in the case symptoms get worse or not revert after certain time.HOW SHOULD I USE (comercial name)? Include dosage regime and administration method, period of treatment, what to do if a dose is omitted, dosage in children, maximum daily dose, detailed explanations on how to use the product, (may include graphic aids) special observations. (take with meals, etc.)PREPARATION INSTRUCTIONS AND STORAGE CONDITIONSWHAT SHOUD I DO IN CASE OF OVERDOSE, OR IF I TOOK MORE OF THE PRODUCT THAN NECESSARY? Call and intoxication center, or go to the closest medical care center. Include telephone numbers.DO YOU HAVE ANY QUESTIONS? Include “ANMAT Answers” number, and company customer care telephone number.KEEP OUT OF THE REACH OF CHILDRENAT ANY QUESTION CONTACT YOUR DOCTOR OR PHARMACISTStorage conditionMade in…Technical Director:Drug Product Authorized by the Ministry of HealthCertificate NumberDate of last authorized labeling text:Presentations:In the packaging labeling text:Brand nameGeneric name – dose/concentrationPharmaceutical formWHAT DOES (comercial name) CONTAIN? Quantity of API, per dosage unit or percentual. Qualitative list of excipients.ACTION/SWHAT IS (comercial name) USED FOR? Symptoms and usesHOW SHOULD I USE (comercial name)? Include dosage regime and administration method, period of treatment, what to do if a dose is omitted, dosage in children, maximum daily dose, detailed explanations on how to use the product, (may include graphic aids) special observations. (take with meals, etc.)DON’T USE THIS DRUG PRODUCT IF YOU…The marketed condition (over the counter) should be remarked. (bold font)Share this:

Pharma Regulatory Affairs in Argentina 2013 Presentation Transcript

  • 1. Pharma Regulatory Affairs in Argentina Steady regulations in a turbulent environment María Inés Guaia October 2013 - Prague
  • 2. Argentina: an emerging economy $435.6 billion GDP Services 60% Industry 30% #27 World #3 Latin America Agriculture 10% 8.8% annual growth rate #12 World #1 Latin America 40 million people 13 million in Buenos Aires and surroundings 30% below poverty line
  • 3. HealthCare and Pharma in Argentina 8.5% of GDP in HealthCare Voluntary insurance HealthCare 9% Voluntary + Social security 4% Pharma industry revenue: about $4,000 million / year More than half of the market is taken by local pharmaceutical companies system Nervous System 15.9 Cardiovascular system 14.2 Digestive system No coverage 38% Social Security 48% 13.8 Systemic antiinfectious 11.2 Antineoplasic and inmunomodulators 11.0 Muscle-skeleton aparatus 7.7 %
  • 4. The drug agency in Argentina National Regulatory Authority of Regional Reference (PAHO/WHO) National Administration of Drugs, Food and Medical Technology National Institute of Medicines Direction of Drug Product Evaluation Direction of Planning and Institutional Relations Clinical evaluation Direction for Coordination and Administration National Institute of Food Direction of Legal Affairs (INAME) Control of sites, processes, activities, technolog ies: manufacturing, importation, fractionin g, marketing Direction of Medical Technology
  • 5. Structuring the submission dossier Different cases
  • 6. Drug registration in Argentina Decree 150/1992 and modifications Lists of countries by sanitary trust level ANNEX I USA France High Sanitary Surveillance Japan United Kingdom Sweden Netherlands Switzerland Belgium Israel Denmark Canada Spain Austria Italy Germany ANNEX II Australia China Mexico Luxembourg Brazil Norway Cuba New Zealand Chile Finland Hungary Ireland
  • 7. Drug registration in Argentina ‘Article 3’ products • Product information - name, formula, pharmaceutical form, pharmacologic classification, marketing condition  DPs manufactured in Argentina or an Annex II country, similar to DPs already registered in Argentina. • Technical information - testing standard,  DPs manufactured in Argentina, with marketing authorization in an Annex I country, even if ‘novel’*. • Labeling texts (packaging and leaflets) specifications, shelf life, manufacturing method, pharmaceutical equivalençce evidence • Timeline for approval: about 12 months * ‘Novel’ products: there are no similar products registered in Argentina If manufactured in an Annex II country: CPP of origin (marketed) • GMP from Annex I country or Argentina
  • 8. Drug registration in Argentina ‘Article 4’ products  DPs with marketing authorization in at least one Annex I country. • CPP from Annex I country – Marketed status • Labeling texts (packaging and leaflets) Timeline for approval: about 10 months • Technical information - only upon authority request
  • 9. Drug registration in Argentina = ‘Article 3’ DPs ‘Article 5’ products  ‘Novel’* DPs manufactured in Argentina.  ‘Novel’* DPs manufactured in an Annex II country.  DPs manufactured in a non-Annex I, nonAnnex II country, and not authorized in any Annex I country. Timeline for approval: not less than 3 years • Product information • Technical information • Labeling texts • If manufactured in an Annex II country: CPP of origin (marketed) • GMP from Annex I country or Argentina plus Safety and efficacy data
  • 10. Biotech registration in Argentina Regulation: October 2011 • • • • • Hemoderivatives Products obtained with recombinant DNA techniques Monoclonal antibodies Biological drugs produced from animal tissues or biologic fluids Other biological products  Biosimilar/biocomparable drugs
  • 11. GMP inspections from ANMAT Application for inspection: documents When? For DP manufacturing sites when not in Annex I country, and without certificate from Annex I country. • DP specific • Agreement with MERCOSUR countries (e.g. ANVISA) • • • • • • • • • • Written request Copy of ANMAT authorization to requestor Information on manufacturer/s Site Master File Site authorization from HA in country in which it is. List of pharmaceutical forms manufactured in 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
  • 12. Post-submission actions and lifecycle management
  • 13. ‘First Batch Verification’ • • • New product registration • New concentration of biologic or smalltherapeutic-window APIs • New pharmaceutical form • Marketing authorization transfer Local manufacturing Importation of drugs Local QC Submit form , manufacturing/QC schedule, technical information, pay fee ANMAT inspects ANMAT doesn’t inspect Send manufacturing/QC documents Positive outcome Marketing Authorization
  • 14. Renewal of certificate Documents Every 5 years (within 30 days prior to certificate expiration date) • Written request • Sworn statement – marketed/non marketed status • Evidence of marketing • Certified copy of original certificate Relatively simple procedure • Copy of last approved labeling texts
  • 15. Variations of regulatory impact Examples: • Change of excipients • Change of manufacturer or manufacturer’s name (only for DP) • Change in labeling texts – leaflets and packaging – including new indications • Shelf life extension • Change of marketing condition • Marketing authorization transfer • New primary packaging material www.niniguaia.wordpress.com Submit documents (very variable requirements) Wait for approval
  • 16. New Opportunities and Challenges
  • 17. eSubmissions: step by step 2010: ‘depaperization’ project Goals: better service – efficient administration – lower costs – greater transparency Currently: • • • • Electronic payment Digital signature Clinical studies submissions Importation authorization requests for dietary supplements and medical devices • Submissions for registration of cosmetics • NEW! JULY 2013: Adverse reactions reports (pharmacovigilance)
  • 18. New OTC labeling regulations Study: Patients had trouble interpreting the content of PILs Information in question format February 2012 new definitions and guidelines for labeling texts in leaflets and packaging of all OTC drug products What is…? What is … used for? What warnings are required before/during the use of…? How should I use…? What should I do if…? Illustrations may be added for better understanding • 2 years for submitting updated texts • Immediate application for new registrations, variations and change of marketing condition Only information relevant to the patient in layman’s terms
  • 19. More new labeling regulations! Active lobbying by celiac disease association May 2013 new requirement of information on gluten content in leaflets and labeling texts of all drug products ‘This drug product is gluten-free’ + analyses to show that products are glutenfree + GMP certificates to proof no contamination ‘This drug product contains gluten’ or 1 year (from 2nd May 2013) for all oral-dose products to comply
  • 20. Orphan Drugs Orphan Drug Regulations • • Low frequency disorders (<1/2000) Severe diseases (risk of incapacity or death) Previously: only special process for importation of drugs for compassionate use • Complete information of (at least) early phases of clinical research (preclinical and phases I and/or II) – adapted trials August 2012 regulation for registration of • Evidence of orphan status • • Plan of efficacy, efficiency and safety monitoring (patient register, prescription/distribution scheme) Periodic reports • Intensive pharmacovigilance • Informed consent • Labeling: ‘AUTHORIZED UNDER SPECIAL ‘under special conditions’ drugs  Definitions  Requirements  Creation of special committee of evaluation CONDITIONS’
  • 21. Thank you! Muchas gracias! www.niniguaia.wordpress.com