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  1. 1. ANVISAAgencia Nacional de VigilanciaSanitariaBy Prashant PatelDepartment of pharmaceuticaltechnologyIndukaka Ipcowala college of pharmacy
  2. 2. Background The National Health Surveillance Agency wasestablished in 1999 by president Fernando HenriqueCardoso. Linked to the Ministry of Health, the agencycoordinates: The National Sanitary Surveillance System The National Program of Blood and Blood Products The National Program of Prevention and Control ofHospital Infections
  3. 3.  Anvisa is responsible for monitoring drug prices prices of medical devices control and inspection of smoking products technical support in granting of patents by the NationalInstitute of Industrial Property. protection of the health of the population by exercisingsanitary control over production marketing of products and services subject to sanitarysurveillance, controlling ports, airports and borders linked to the Brazilian Ministry of Foreign Affairs and foreigninstitutions over matters concerning international aspects ofsanitary surveillance.
  4. 4. ANVISA is a part of NSSS National System of Sanitary Surveillance (NSSS) is anorganization of Brazil whose responsibility is to keep a watch over certain professional activities to put a stop to charlatanism to inspect ships, cemeteries and places where food was onsale to the public.
  5. 5.  The federal, state and municipal units of this sanitarysurveillance are: National Agency for Sanitary Surveillance (ANVISA) The National Council of State Health Secretaries(CONASS) The National Council of Municipal Health Secretaries(CONASEMS) The State, Federal District and Municipal SanitarySurveillance Centers (VISAS) The Central Public Health Laboratories (LACENS) The National Institute for Quality Control in Health(INCQS) The Oswaldo Cruz Foundation (FIOCRUZ)
  6. 6.  Anvisas Mission "To protect and promote health, ensuring thehygiene and safety of products and services andtaking part in developing access to it." Values Transparency Knowledge (as a springboard for action) Cooperation Vision To be an agent for transformation of thedecentralized sanitary surveillance system, within anetwork, holding a distinct position, legitimized bythe population, as regulator and promotor of social
  7. 7. ANVISA Offices: ANVISA has main two offices: Advisory council andOffice of Ombudsman. Advisory Council It monitors and follows up the development ofactivities carried out by ANVISA. Council comprise of Representatives from… Public Administration Institutions Organized Civil Society Scientific Community Function - to provide information upon request by anycitizen, patient, industrialist or health professional on anytopics.
  8. 8.  Office of ombudsman It is an independent body for direct communication ofCitizens or Institutes to attend the Complaints. It is characterized by impartiality and transparency. It has no direct or indirect linking with ANVISA. It isregulated directly under the Brazilian ministry ofhealth. It Start action against complaints within 2days, if appropriate.
  9. 9. Health Protection Blood, Tissues, and Organs Cosmetics Drugs Food Health Related Services Health Related Products Laboratories Medicine Bioavailability/Bioequivalence Centers Pesticides and Toxicology Pharmaceutical Ingredients Ports, Airports, and Borders Sanitizing Products Tobacco Products
  10. 10. Blood, Tissues, andOrgans To assure the quality of treatments based on the use ofblood, other tissues, cells, and human organs , Anvisaformulates technical rules, inspects services, andmonitors the occurrence of adverse reactions caused bytechnologies available in Brazil. Products and processes that don’t follow qualitystandards may be harmful and cause the transmission ofdiseases such as AIDS, and Hepatitis B and C. For thatreason, the Brazilian Health Surveillance Agency worksto diminish or to avoid completely those risks.
  11. 11. Cosmetics responsible for surveilling the marketing of hygieneproducts, cosmetics, and perfumes. To guarantee thequality of those products, Anvisa works at registration,notification, and inspection. The agency also creates norms and rules applicable tothe production processes, the techniques, the methodsand the use of those products by consumers.
  12. 12. Drugs responsible for drug registration and licenses topharmaceutical laboratories and to other companies insidethe pharmaceutical production flow. for establishing regulations applicable to clinical trials anddrug pricing, which is carried out by the Chamber of DrugMarket Regulation (CMED).
  13. 13.  Together with states and municipalities, the agencyinspects Factories monitors the quality of drugs exercises post-marketing surveillance takes pharmacovigilance actions regulates drug promotion and marketing. analyzing patent requests related to pharmaceuticalprocesses and products, in partnership with theNational Industrial Property Institute (INPI).Drugs
  14. 14. Food coordinates, supervises, and controls activitiesregarding registration, information, inspection, riskcontrol, and rulemaking to assure health surveillanceover food, beverages, water, ingredients, packages,technologies, contamination limits, and veterinaryresidues. This work is done in cooperation with othergovernmental bodies, such as the Ministry of Agriculture,Livestock and Food Supply and the state and municipalhealth offices, which take part of the National HealthSurveillance System.
  15. 15. Health Related Services Health care quality is inextricably related to riskmonitoring. For that reason, health related servicessurveillance is a necessary task, for it improves thequality of health services Anvisa coordinates nationwide health related servicessurveillance actions, which are carried out bystates, municipalities, and the Federal District. Besides, the agency formulates and enforcesrules, establishes controlling mechanisms, andassesses risks and adverse events regarding healthprovision in hospitals, clinics, and health posts.
  16. 16. Health Related Products Health related products is a huge area comprised ofdifferent levels of complexity, including infraredlamps, magnetic resonance equipment, gauzecompress, hip prosthesis, culture medium, and HIV testkit. Those products are used in medical, dental, andphysiotherapeutic procedures, as well as indiagnosis, treatment, rehabilitation and patientmonitoring.
  17. 17. Laboratories responsible for coordinating health surveillance actions oflaboratories that take part of the official health quality controllaboratory net. In 2004,they created the Public Health Laboratories NationalSystem (SISLAB), to help improve the effectiveness of healthsurveillance actions. Laboratories Net performs analysis of products and servicessuch as food, drugs, cosmetics, sanitizing products,immunobiologicals, blood products, toxic substances, biologicaland non-biological contaminants, health materials andequipment. Those analyses include areas of ports, airports,and frontiers. The base of this net is formed by the National Institute forQuality Control in Health (INCQS), the State Health Public
  18. 18. Pesticides and Toxicology Assessing, regulating, controlling and inspectingproducts and services that pose health risks, includingpesticides, pesticides components, and other chemicalsubstances studied by toxicology. The agency carries out toxicological analysis for newpesticides registration and for the reevaluation ofmolecules that have already been registered.
  19. 19. Pharmaceutical Ingredients To assure the quality of drug production, Anvisa issues workinglicenses and exerts health control over pharmaceuticalingredients, by means of health inspection and rulemaking. Anvisa is also responsible for investigating notifications onquality control deviation. The pharmaceutical ingredientsrepresent the beginning of the pharmaceutical industryproduction flow. Anvisa is also responsible for analysing notifications on qualitycontrol deviation.
  20. 20. Ports, Airports and Borders Anvisa is committed to assuring the health control ofports, airports, and borders. This is an important task, sinceit protects the health of travelers, and guaranties the safetyof means of transport and services in those areas. This work involves environments, processes, productregistration and approval, including ingredients andtechnologies. Therefore, Anvisa enforces national andinternational law such as the WHO International HealthRegulations (IHR), and other international acts signed byBrazil.
  21. 21. Sanitizing Products Sanitizing products are largely used for cleansing andprotecting environments such as houses, offices, shops,and hospitals. To assure the efficacy of those products,Anvisa makes their registration and notification,observing all quality standards. to enable quality improvement , the agency draws uprules and standards, helps organizing information aboutadverse events caused by sanitizing products,undertakes constant risk assessment, monitors scientificand technological development, and adopts correctiveprocedures to eliminate, avoid or diminish the hazardsrelated to sanitizing products.
  22. 22. Tobacco Products Includes rulemaking and law enforcement. To diminishtobacco use, the agency has develop many actions:obliged the use of health warnings on cigarettepackages and in cigarette advertising, prohibitedtobacco advertising outside tobacco shops as well asfood production that simulate tobacco products
  23. 23. Postmarketing Surveillance Advertising Monitoring Hemovigilance Market Regulation Pharmacovigilance Technovigilance
  24. 24. Technovigilance Technovigilance is a system created for monitoring after-marketing adverse events and technical complaintsabout health products. The system aims at providing recommendations andadopting measures that assure public promotion andprotection against hazards caused by products such ashealth equipment, health materials, medical devices, invitro diagnostic products, and implants.
  25. 25. Advertising Monitoring Anvisa promotes public education and monitorsadvertising that may pose public health hazards. Bothkinds of work have been developed to reduce publicexposure to misleading and abusive advertising and tohelp prevent problems such as self-medication,intoxication, inadequate use of drugs and food. This way, Anvisa aims at diminishing hazards to health,supporting legislation improvement, and fosteringpolicies towards health education.
  26. 26. Hemovigilance Hemovigilance is understood as a group of proceduresdeveloped to monitor transfusion reactions. This work is doneto improve the quality of processes and products used inhemotherapies and to provide patients safer treatments. Health services that offer hemotherapies carry outprocedures to identify transfusion reactions or any adverseevents caused by blood and blood products therapies. Thosereactions should be notified, after which they become usefulinformation to identify risks and to avoid health problemsoccurrence or reoccurrence. Hemovigilance procedures are organized by the NationalSystem of Hemovigilance (SNH), which is coordinated byAnvisa.
  27. 27. Pharmacovigilance Pharmacovigilance monitors drugs in the market. This kind ofpost-marketing surveillance is put into practice by Anvisa, incooperation with states, municipalities and the FederalDistrict. Although drugs are produced to prevent, alleviate or curediseases, they may cause undesirable and harmful effects. This duality, sometimes tragic, is very significant to publichealth and makes pharmacovigilance essential to healthsurveillance in any country. Pharmacovigilance protectspeople from harm by previously identifying risks and timelyacting.
  28. 28. ANVISA - Guidlines REGISTRATION OF NEW DRUG Registration procedure of new drug is divided in mainly 3 partsas follows… Pre-registration measures Protocol for Clinical study Registration Documents to be submitted Protocol for the new drug Protocol for import of new drug Post-registration Alteration in Registration, Renewal of Registration Thus, considered similar to IND, NDA and SupplementaryNDA as per US FDA.
  29. 29. TECHNICAL REGULATION OFGENEERIC DRUGS Registration procedure for Generic drug is similar to newdrug registration. Pre registration measures Registration Post registration Additional Requirements in registration includes… Pharmaceutical Equivalence : Generic and Reference If anyone of Generic or Reference is Coated tablet, provethat coating does not present Gastro-protection Bioequivalence study in Laboratories duly authorized byANVISA Exemption of Bioequivalence study Based on comparison of dissolution profile For BCS Class I product – High solubility & permeability
  30. 30. Medicines NOT accepted as GENERIC Parenteral that don’t contain API like WFI, glucosesolution, NaCl solution, electrolytes solution etc. Biological products: Blood, Plasma products Products obtained through Biotech except antibiotics Herbal drug products Vitamins &/or Mineral salts Antiseptics for Hospital use Endogenous Hormones of oral use Products with Diagnostic purpose and Radiologicalcontrasts Some of OTC products
  31. 31. HARMONIZATION OF ALREADYREGISTERED DRUGS ANVISA had introduced some modification inRegistration procedures and Documents after 1stDecember 2004. Drugs Registered before this date, has to submitinformation or data or documents related to drug, forharmonization with Newer Registered drug products.
  32. 32. GITE: List of Specified TherapeuticGroup & Indication Drugs described in GITE can be sold OTC Parenterals can not sold OTC (can not sell withoutPrescription) Drugs not listed in GITE can not sell withoutPRESCRIPTION. Any NEW DRUG, not to be sold under GITE If New Drug has minimum 5 years experience in USA orEuropean market (with FDA or EMEA approval), and if itcomes under GITE list, applicator may request toclassify it as OTC product.
  33. 33. HOMEOPATHIC DRUGS Registration of Homeopathic drugs is valid upto 5 years. For Injectable Homeopathic medicines, applicator has tosubmit Risk/Benefit compared with oral presentation ofsame product Combination of any synthetic/ semi-synthetic/ biologicalproduct/ vitamins/ mineral salts/ herbal along withHomeopathic is FORBIDDEN.
  34. 34. IN VITRO DIAGNOSTIC PRODUCT ANVISA had classified in vitro diagnostic product into 4classes as follows… Group A - Materials, devices, accessories & inputs forsupport of in vitro diagnostic products. Group B - for diagnosis of non-transmissible diseases. Group C - for diagnosis of infectious-contagious diseases,except those classified in Group D. Group D - for diagnosis of infectious-contagious diseases,sexually transmissible diseases or diseases spread byblood and blood products, as well as identification of bloodgroups, transfusion or preparation of blood products.
  35. 35.  Documents required for Registration… Application form, Fee payment receipt Copy of License or Permit for Manufacturing. Label on the package of product, Instruction for Use Technical Report If imported, proof of Registration at competent healthagency of importing country
  36. 36. GMP As per the latest updates of “GMP Guide forPharmaceutical Industry” approved by WHO’s WorldHealth Assembly – WHA. GMP Certificate is Valid upto 1 year only
  37. 37. BA – BE GUIDELINES Clinical Stage Analytical Stage Statistical Stage BA – BE GOOD PRACTICE MANUAL
  38. 38. OTHER FUNCTIONS OF ANVISA: REBLAS - Brazilian Network of Analytical Laboratories.It is the laboratory network and every analysis andclinical studies must be performing at any one of theREBLAS center approved by ANVISA.
  39. 39. INDIAN PHARMA IN BRAZILIANMARKET Prominent among themare: Zydus Cadila Torrent Pharmaceuticals Dr. Reddys Labs Ranbaxy Pharmaceuticals Intas Pharmaceuticals Sun Pharmaceuticals The major drugs exportedare: Losartan Potassium Zolpidem tartarate Alprazolam Enalapril Maleate Nortryptiline Carbamazepine Clonazepam Fluconazole Fluoxetine, etc.
  40. 40. THANK YOU !!!!!!!!
  41. 41. ANVISAAgencia Nacional de VigilanciaSanitariaBy Prashant Patel(M.pharm sem-2)Department of pharmaceuticaltechnologyGuided by:Dr. D. R. C.Department of Pharmaceuticaltechnology