ANVISAAgencia Nacional de VigilanciaSanitaria By Prashant Patel (M.pharm sem-2) Department of pharmaceutical technology Indukaka Ipcowala college of pharmacy
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
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.
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.
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)
Anvisas 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
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.
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.
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
Blood, Tissues, andOrgans 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.
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.
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).
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).
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.
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.
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.
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
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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
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
HARMONIZATION OF ALREADYREGISTERED 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.
GITE: List of Specified TherapeuticGroup & 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.
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.
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.
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
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
BA – BE GUIDELINES Clinical Stage Analytical Stage Statistical Stage BA – BE GOOD PRACTICE MANUAL
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.
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.