Anvisa

ANVISAAgencia Nacional de Vigilancia Sanitaria

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) The State, District and Municipal Health Councils

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 well-being.

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, 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.

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).

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).

Drugs

Food

coordinates, supervises, and controls activities regarding registration, information, inspection, risk control, and rulemaking to assure health surveillance over food, beverages, water, ingredients, packages, technologies, 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 Laboratories (LACEN), and other laboratories determined by current legislation.

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

Postmarketing Surveillance

Advertising Monitoring Hemovigilance Market Regulation Pharmacovigilance Technovigilance

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 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.

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.

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 are: Zydus Cadila Torrent Pharmaceuticals Dr. Reddys Labs Ranbaxy

Pharmaceuticals Intas Pharmaceuticals

Sun Pharmaceuticals

The major drugs exported are: Losartan Potassium Zolpidem tartarate Alprazolam Enalapril Maleate Nortryptiline Carbamazepine Clonazepam Fluconazole Fluoxetine, etc.

THANK YOU !!!!!!!!

ANVISAAgencia Nacional de Vigilancia Sanitaria

By Prashant Patel(M.pharm sem-2)Department of pharmaceutical technology

Guided by:Dr. D. R. C.Department of Pharmaceutical technology