1. ANVISA
Agencia Nacional de Vigilancia
Sanitaria
By Prashant Patel
(M.pharm sem-2)
Department of pharmaceutical
technology
Indukaka Ipcowala college of pharmacy

2. Background
 The National Health Surveillance Agency was
established in 1999 by president Fernando Henrique
Cardoso. Linked to the Ministry of Health, the agency
coordinates:
 The National Sanitary Surveillance System
 The National Program of Blood and Blood Products
 The National Program of Prevention and Control of
Hospital Infections

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 National
Institute of Industrial Property.
 protection of the health of the population by exercising
sanitary control over production
 marketing of products and services subject to sanitary
surveillance, controlling ports, airports and borders
 linked to the Brazilian Ministry of Foreign Affairs and foreign
institutions over matters concerning international aspects of
sanitary surveillance.

4. ANVISA is a part of NSSS
 National System of Sanitary Surveillance (NSSS) is an
organization 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 on
sale to the public.

5.  The federal, state and municipal units of this sanitary
surveillance 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 Sanitary
Surveillance Centers (VISAS)
 The Central Public Health Laboratories (LACENS)
 The National Institute for Quality Control in Health
(INCQS)
 The Oswaldo Cruz Foundation (FIOCRUZ)

6.  Anvisa's Mission
 "To protect and promote health, ensuring the
hygiene and safety of products and services and
taking part in developing access to it."
 Values
 Transparency
 Knowledge (as a springboard for action)
 Cooperation
 Vision
 To be an agent for transformation of the
decentralized sanitary surveillance system, within a
network, holding a distinct position, legitimized by
the population, as regulator and promotor of social

7. ANVISA Offices:
 ANVISA has main two offices: Advisory council and
Office of Ombudsman.
 Advisory Council
 It monitors and follows up the development of
activities carried out by ANVISA.
 Council comprise of Representatives from…
 Public Administration Institutions
 Organized Civil Society
 Scientific Community
 Function - to provide information upon request by any
citizen, patient, industrialist or health professional on any
topics.

8.  Office of ombudsman
 It is an independent body for direct communication of
Citizens or Institutes to attend the Complaints.
 It is characterized by impartiality and transparency.
 It has no direct or indirect linking with ANVISA. It is
regulated directly under the Brazilian ministry of
health. It Start action against complaints within 2
days, if appropriate.

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. Blood, Tissues, and
Organs
 To assure the quality of treatments based on the use of
blood, other tissues, cells, and human organs , Anvisa
formulates technical rules, inspects services, and
monitors the occurrence of adverse reactions caused by
technologies available in Brazil.
 Products and processes that don’t follow quality
standards may be harmful and cause the transmission of
diseases such as AIDS, and Hepatitis B and C. For that
reason, the Brazilian Health Surveillance Agency works
to diminish or to avoid completely those risks.

11. Cosmetics
 responsible for surveilling the marketing of hygiene
products, cosmetics, and perfumes. To guarantee the
quality of those products, Anvisa works at
registration, notification, and inspection.
 The agency also creates norms and rules applicable to
the production processes, the techniques, the methods
and the use of those products by consumers.

12. Drugs
 responsible for drug registration and licenses to
pharmaceutical laboratories and to other companies inside
the pharmaceutical production flow.
 for establishing regulations applicable to clinical trials and
drug pricing, which is carried out by the Chamber of Drug
Market Regulation (CMED).

13. Drugs
 Together with states and municipalities, the agency
inspects
 Factories
 monitors the quality of drugs
 exercises post-marketing surveillance
 takes pharmacovigilance actions
 regulates drug promotion and marketing.
 analyzing patent requests related to pharmaceutical
processes and products, in partnership with the
National Industrial Property Institute (INPI).

14. Food
 coordinates, supervises, and controls activities
regarding registration, information, inspection, risk
control, and rulemaking to assure health surveillance
over
food, beverages, water, ingredients, packages, technolo
gies, contamination limits, and veterinary residues.
 This work is done in cooperation with other
governmental bodies, such as the Ministry of
Agriculture, Livestock and Food Supply and the state
and municipal health offices, which take part of the
National Health Surveillance System.

15. Health Related Services
 Health care quality is inextricably related to risk
monitoring. For that reason, health related services
surveillance is a necessary task, for it improves the
quality of health services
 Anvisa coordinates nationwide health related services
surveillance actions, which are carried out by states,
municipalities, and the Federal District.
 Besides, the agency formulates and enforces rules,
establishes controlling mechanisms, and assesses risks
and adverse events regarding health provision in
hospitals, clinics, and health posts.

16. Health Related Products
 Health related products is a huge area comprised of
different levels of complexity, including infrared
lamps, magnetic resonance equipment, gauze
compress, hip prosthesis, culture medium, and HIV test
kit.
 Those products are used in medical, dental, and
physiotherapeutic procedures, as well as in
diagnosis, treatment, rehabilitation and patient
monitoring.

17. Laboratories
 responsible for coordinating health surveillance actions of
laboratories that take part of the official health quality control
laboratory net.
 In 2004,they created the Public Health Laboratories National
System (SISLAB), to help improve the effectiveness of health
surveillance actions.
 Laboratories Net performs analysis of products and services
such as food, drugs, cosmetics, sanitizing
products, immunobiologicals, blood products, toxic
substances, biological and non-biological contaminants, health
materials and equipment. Those analyses include areas of
ports, airports, and frontiers.
 The base of this net is formed by the National Institute for
Quality Control in Health (INCQS), the State Health Public

18. Pesticides and Toxicology
 Assessing, regulating, controlling and inspecting
products and services that pose health risks, including
pesticides, pesticides components, and other chemical
substances studied by toxicology.
 The agency carries out toxicological analysis for new
pesticides registration and for the reevaluation of
molecules that have already been registered.

19. Pharmaceutical Ingredients
 To assure the quality of drug production, Anvisa issues working
licenses and exerts health control over pharmaceutical
ingredients, by means of health inspection and rulemaking.
 Anvisa is also responsible for investigating notifications on
quality control deviation. The pharmaceutical ingredients
represent the beginning of the pharmaceutical industry
production flow.
 Anvisa is also responsible for analysing notifications on quality
control deviation.

20. Ports, Airports and Borders
 Anvisa is committed to assuring the health control of
ports, airports, and borders. This is an important task, since
it protects the health of travelers, and guaranties the safety
of means of transport and services in those areas.
 This work involves environments, processes, product
registration and approval, including ingredients and
technologies. Therefore, Anvisa enforces national and
international law such as the WHO International Health
Regulations (IHR), and other international acts signed by
Brazil.

21. Sanitizing Products
 Sanitizing products are largely used for cleansing and
protecting 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 up
rules and standards, helps organizing information about
adverse events caused by sanitizing
products, undertakes constant risk
assessment, monitors scientific and technological
development, and adopts corrective procedures to
eliminate, avoid or diminish the hazards related to
sanitizing products.

22. Tobacco Products
 Includes rulemaking and law enforcement. To diminish
tobacco use, the agency has develop many actions:
obliged the use of health warnings on cigarette
packages and in cigarette advertising, prohibited
tobacco advertising outside tobacco shops as well as
food production that simulate tobacco products

23. Postmarketing Surveillance
 Advertising Monitoring
 Hemovigilance
 Market Regulation
 Pharmacovigilance
 Technovigilance

24. Technovigilance
 Technovigilance is a system created for monitoring after-
marketing adverse events and technical complaints
about health products.
 The system aims at providing recommendations and
adopting measures that assure public promotion and
protection against hazards caused by products such as
health equipment, health materials, medical devices, in
vitro diagnostic products, and implants.

25. Advertising Monitoring
 Anvisa promotes public education and monitors
advertising that may pose public health hazards. Both
kinds of work have been developed to reduce public
exposure to misleading and abusive advertising and to
help 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 fostering
policies towards health education.

26. Hemovigilance
 Hemovigilance is understood as a group of procedures
developed to monitor transfusion reactions. This work is done
to improve the quality of processes and products used in
hemotherapies and to provide patients safer treatments.
 Health services that offer hemotherapies carry out
procedures to identify transfusion reactions or any adverse
events caused by blood and blood products therapies. Those
reactions should be notified, after which they become useful
information to identify risks and to avoid health problems
occurrence or reoccurrence.
 Hemovigilance procedures are organized by the National
System of Hemovigilance (SNH), which is coordinated by
Anvisa.

27. Pharmacovigilance
 Pharmacovigilance monitors drugs in the market. This kind of
post-marketing surveillance is put into practice by Anvisa, in
cooperation with states, municipalities and the Federal
District.
 Although drugs are produced to prevent, alleviate or cure
diseases, they may cause undesirable and harmful effects.
 This duality, sometimes tragic, is very significant to public
health and makes pharmacovigilance essential to health
surveillance in any country. Pharmacovigilance protects
people from harm by previously identifying risks and timely
acting.

28. ANVISA - Guidlines
 REGISTRATION OF NEW DRUG
 Registration procedure of new drug is divided in mainly 3 parts
as 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 Supplementary
NDA as per US FDA.

29. TECHNICAL REGULATION OF
GENEERIC DRUGS
 Registration procedure for Generic drug is similar to new
drug 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, prove
that coating does not present Gastro-protection
 Bioequivalence study in Laboratories duly authorized by
ANVISA
 Exemption of Bioequivalence study
 Based on comparison of dissolution profile
 For BCS Class I product – High solubility & permeability

30. Medicines NOT accepted as GENERIC
 Parenteral that don’t contain API like WFI, glucose
solution, 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 Radiological
contrasts
 Some of OTC products

31. HARMONIZATION OF ALREADY
REGISTERED DRUGS
 ANVISA had introduced some modification in
Registration procedures and Documents after 1st
December 2004.
 Drugs Registered before this date, has to submit
information or data or documents related to drug, for
harmonization with Newer Registered drug products.

32. GITE: List of Specified Therapeutic
Group & Indication
 Drugs described in GITE can be sold OTC
 Parenterals can not sold OTC (can not sell without
Prescription)
 Drugs not listed in GITE can not sell without
PRESCRIPTION.
 Any NEW DRUG, not to be sold under GITE
 If New Drug has minimum 5 years experience in USA or
European market (with FDA or EMEA approval), and if it
comes under GITE list, applicator may request to
classify it as OTC product.

33. HOMEOPATHIC DRUGS
 Registration of Homeopathic drugs is valid upto 5 years.
 For Injectable Homeopathic medicines, applicator has to
submit Risk/Benefit compared with oral presentation of
same product
 Combination of any synthetic/ semi-synthetic/ biological
product/ vitamins/ mineral salts/ herbal along with
Homeopathic is FORBIDDEN.

34. IN VITRO DIAGNOSTIC PRODUCT
 ANVISA had classified in vitro diagnostic product into 4
classes as follows…
 Group A - Materials, devices, accessories & inputs for
support 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 by blood and blood products, as well as
identification of blood groups, transfusion or preparation of
blood products.

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 health
agency of importing country

36. GMP
 As per the latest updates of “GMP Guide for
Pharmaceutical Industry” approved by WHO’s World
Health Assembly – WHA.
 GMP Certificate is Valid upto 1 year only

37. BA – BE GUIDELINES
 Clinical Stage
 Analytical Stage
 Statistical Stage
 BA – BE GOOD PRACTICE MANUAL

38. OTHER FUNCTIONS OF ANVISA:
 REBLAS - Brazilian Network of Analytical Laboratories.
It is the laboratory network and every analysis and
clinical studies must be performing at any one of the
REBLAS center approved by ANVISA.

39. INDIAN PHARMA IN BRAZILIAN
MARKET
 Prominent among them  The major drugs exported
are: are:
 Zydus Cadila  Losartan Potassium
 Torrent Pharmaceuticals  Zolpidem tartarate
 Dr. Reddys Labs  Alprazolam
 Ranbaxy Pharmaceuticals  Enalapril Maleate
 Intas Pharmaceuticals  Nortryptiline
 Sun Pharmaceuticals  Carbamazepine
 Clonazepam
 Fluconazole
 Fluoxetine, etc.

40. THANK YOU !!!!!!!!

41. ANVISA
Agencia Nacional de Vigilancia
Sanitaria
Guided by: By Prashant Patel
Dr. D. R. C. (M.pharm sem-2)
Department of Pharmaceutical Department of pharmaceutical
technology technology