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Name: Sk. Shaik Banu
Reg.No.12P21R0050
Course: B.Pharmacy IV -I Sem
Guide:
Mr. Voleti.Vijaya Kumar M.Pharmacy.,
Assistant ...
Contents
Definitions
Introduction
Functions of DRA’s
Regulatory agencies in US
- FDA
Canadian HPFBI
Australian TGA
...
Definitions
■Regulatory Affairs is a comparatively new profession which has
developed from the desire of governments to pr...
Introduction:
.
To protect consumer’s health
against harm resulting from
poor quality medicinal
products, drug regulatory
...
Functions of DRA’s
■Licensing, registration and labelling of new pharmaceutical
products.
■Inspection of manufacturing fac...
US FDA
TGA
HPFBI
CDSCO
United states food and drugs
administration
.
•It is an agency of one of the United States federal Human Services.
•The ma...
Offices of inspectorate Responsibilities
Office of the commissioner Centre for scientific activities, policy making and pl...
Canadian Health Products and
Food Branch Inspectorate
■It helps canadians to maintain and improve their health whilst
resp...
The HPFBI has 10 responsibility offices which are
discussed below:
Offices of inspectorate Responsibilities
1 Director Gen...
■It was formed under the Therapeutic Goods Act 1989 to
regulate therapeutic goods including medicines, medical
devices, bl...
Organisation structure:
Offices Responsibilities
Market Authorization Group (MAG) To decide whether or not to approve the
...
Functions of TGA:
■Evaluation of the quality, safety and efficacy of prescription
drugs and other drugs like OTC medicines...
■It is a drug regulatory organization of India.
■The vision of CDSCO is to protect and promote public health
in India and ...
Functions:
■Laying down the safety and quality standards for drugs,
cosmetics, diagnostics, and devices.
■Regulatory the m...
■Indian Pharmaceutical Association (IPA) is the premier
professional association of pharmacists in India.
■The association...
Drug Technical Advisory Board (DTAB)
■The Central Government constitute a Board (to be called the
Drugs Technical Advisory...
The Board shall consist of the following members:
10 ex-officio
members
5 Nominated
members
5 Elected
MembersDTAB
-20 memb...
Activities and responsibilities
■It advices matter related to drugs.
■The nominated and elected members of the Board shall...
General body
(19
Members)
Governing
body
(10members)
CIPL lab
Scientific
body
23 experts
IPC
secretariat
IPC
Responsibilities
■Development of comprehensive monographs.
■Accord priority to monographs of drugs included in the
nationa...
Indian council of Medical Research (ICMR)
■The Indian Council of Medical Research
(ICMR), New Delhi, the apex body in
Indi...
Indian Council of Medical Research
Structure and
organization
Responsibilities
■Extramural research is promotes by ICMR by establishing
■Open ended research is conducted on the basis o...
References
1. Hasumati Rahalkar, Historical Overview of Pharmaceutical Industry and Drug
Regulatory Affairs, Kurz, Pharmac...
Regulatory agencies
Regulatory agencies
Regulatory agencies
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Regulatory agencies

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Introduction of various regulatory agencies

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Regulatory agencies

  1. 1. Name: Sk. Shaik Banu Reg.No.12P21R0050 Course: B.Pharmacy IV -I Sem Guide: Mr. Voleti.Vijaya Kumar M.Pharmacy., Assistant Professor, Dep of Pharmaceutics, RAO'S College of Pharmacy, NELLORE Principal : Dr. P. Shanmuga Pandiyan M.Pharmacy., Ph.d., RAO’S College of Pharmacy, NELLORE
  2. 2. Contents Definitions Introduction Functions of DRA’s Regulatory agencies in US - FDA Canadian HPFBI Australian TGA Regulatory agencies in India -CDSCO -IPA -DTAB -IPC -ICMR
  3. 3. Definitions ■Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines ■Drug Regulatory Affairs is a function which regulates the pharmaceutical science in order to facilitate trade / business in and outside the country of origin for public interest
  4. 4. Introduction: . To protect consumer’s health against harm resulting from poor quality medicinal products, drug regulatory agencies have been developed in many industrialized countries of the world.
  5. 5. Functions of DRA’s ■Licensing, registration and labelling of new pharmaceutical products. ■Inspection of manufacturing facilities and distribution channels ■Training of health care professionals ■Arrangement of awareness programmes for general public
  6. 6. US FDA TGA HPFBI CDSCO
  7. 7. United states food and drugs administration . •It is an agency of one of the United States federal Human Services. •The main role of FDA is to protect and promote public health by controlling and monitoring the manufacture, import, transport, vaccines, cosmetics etc. •It also evaluates the applications for new drugs, biologicals, medical devices, food and infant formulae.
  8. 8. Offices of inspectorate Responsibilities Office of the commissioner Centre for scientific activities, policy making and planning, women’s and minority health initiatives, scientific activities. Centre for biologics evaluation & research To provide information regarding safe and appropriate use of biological therapeutic agents to common public. Centre for devices & radiological health To provide accessible science-based information about the products to the consumers Centre for drug evaluation and research To regulate prescription as well as OTC drugs including biological therapeutics and generic drugs like sunscreen lotions etc. Centre for tobacco products To establish and enforce advertising and promotion restrictions pertaining to tobacco products. Centre for veterinary medicines To review and evaluate the available data regarding safety and efficacy of marketed animal drugs as well as animal drugs under investigation. Centre for food safety and applied nutrition It assures the safety & appropriate labeling of almost all the food products except meat products in US National centre for toxicological research To advance scientific approaches and tools. Office of regulatory affairs investigators inspect the production and warehousing facilities and investigate complaints,
  9. 9. Canadian Health Products and Food Branch Inspectorate ■It helps canadians to maintain and improve their health whilst respecting individual choices and circumstances, aims at listing canada among the countries with the healthiest people in the world. ■The primary function of HPFBI is to implement a national compliance and enforcement program for the products that are under the regulation of Health Canada.
  10. 10. The HPFBI has 10 responsibility offices which are discussed below: Offices of inspectorate Responsibilities 1 Director General’s office To liaise with other directorates, other branch offices and the office of Assistant Deputy Minister. 1 Inspectorate Ottawa Licensing activities 2 Laboratories To ensure support to inspection and investigations 6 Regional Offices To conduct inspection and investigations.
  11. 11. ■It was formed under the Therapeutic Goods Act 1989 to regulate therapeutic goods including medicines, medical devices, blood, tissues and blood products in Australia, thereby protecting public health and safety. ■It also aims to make sure that the Australian community, within a time frame has access to new therapeutic goods.
  12. 12. Organisation structure: Offices Responsibilities Market Authorization Group (MAG) To decide whether or not to approve the therapeutic goods imported, exported, manufactured and supplied in Australia. Monitoring and Compliance Group(MCG) It monitors the therapeutic products approved for the supply in Australia Regulatory Support Group It provides regulatory support services like legal, human resource management, finance, information technology and parliamentary management services.
  13. 13. Functions of TGA: ■Evaluation of the quality, safety and efficacy of prescription drugs and other drugs like OTC medicines, alternative medicines and medical devices. ■To control the export of drugs and medical devices from Australia. ■To control drug and device advertisements. ■To monitor adverse drug reactions.
  14. 14. ■It is a drug regulatory organization of India. ■The vision of CDSCO is to protect and promote public health in India and its mission is to safeguard and enhance public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices.
  15. 15. Functions: ■Laying down the safety and quality standards for drugs, cosmetics, diagnostics, and devices. ■Regulatory the marketing of new drugs. ■Publishing and updating the Indian Pharmacopoeia. ■Guiding on technical matters and monitoring adverse drug reactions. ■Screening the drug formulations that are available in the Indian market.
  16. 16. ■Indian Pharmaceutical Association (IPA) is the premier professional association of pharmacists in India. ■The association has more than 10,000 members from various parts of the country and it operates in India through 17 state branches & more than 33 local branches ■The Indian Pharmaceutical Association (IPA) has demanded to amend the Drugs &Cosmetics Act and Rules 1945 to make only the pharmacy graduates eligible to become expert staffs in the pharma manufacturing units
  17. 17. Drug Technical Advisory Board (DTAB) ■The Central Government constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of D&C, Act 1940
  18. 18. The Board shall consist of the following members: 10 ex-officio members 5 Nominated members 5 Elected MembersDTAB -20 members
  19. 19. Activities and responsibilities ■It advices matter related to drugs. ■The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election. ■The Board may, subject to the previous approval of the central Government, regulating its own procedure.
  20. 20. General body (19 Members) Governing body (10members) CIPL lab Scientific body 23 experts IPC secretariat IPC
  21. 21. Responsibilities ■Development of comprehensive monographs. ■Accord priority to monographs of drugs included in the national essential drug list and their dosage forms. ■Preparation of monographs for products that have normally been in the market for not less than 2 years.
  22. 22. Indian council of Medical Research (ICMR) ■The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.
  23. 23. Indian Council of Medical Research Structure and organization
  24. 24. Responsibilities ■Extramural research is promotes by ICMR by establishing ■Open ended research is conducted on the basis of applications for grants in aid received from scientists in non-ICMR Research institutes, Medical colleges and Universities located in different parts of the country.
  25. 25. References 1. Hasumati Rahalkar, Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs, Kurz, Pharmaceut Reg Affairs 2012, S11-002 http://www.slideshare.net/BeenaMaddi/international-regulatory-agencies http://www.fda.gov/ http://www.hc-sc.gc.ca/index-eng.php https://www.tga.gov.au/ 6,8 http://www.slideshare.net/sampathramaswamy1/regulatory-aspects-17409779 7.http://www.ipapharma.org/ 9. http://www.ipc.gov.in 10. http://www.icmr.nic.in

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