DRUG REGULATORY AGENCIES

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DRUG ReGULATORY AGENCIES IN INDIA, US, EUROPE, JAPAN, ICH . Prepared By : Hitesh M. Parmar M.Pharm Sem-2(Q.A.) 1 Guided By: Mrs.Riddhi Madhu M.Pharm (PhD) Mts. V.B. Manvar College Of Pharmacy Dumiyani

Content:

Meaning Introduction Key function Agencies in INDIA Agencies in US Agencies in JAPAN Agencies in EU ICH References Content 2

MEANING OF DRUG REGULATION:

Drug “ All medicines for internal or external use of human beings or animals and all substances intended to be used for diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals ” Regulation “To regulate means to control something so that it functions properly” MEANING OF DRUG REGULATION 3

INTRODUCTION::

Drugs play an important role in the health of both people and the economy of a country. Pharmaceutical drugs are available from a large number of sources. People and Governments willing to spend money on drugs for many reasons so, it must be safe, effective and good quality and used appropriately. This means, in turn, that development, production, importation, exportation and subsequent distribution of drugs must be regulated to ensure that they meet prescribed standards. Therefore, effective drug regulation is required to ensure the safety, efficacy and quality of drugs as well as accuracy and appropriateness of the drug information available to the public . INTRODUCTION: 4

KEY FUNCTIONS OF DRUG REGULATORY AGENCY::

Product registration (drug evaluation and authorization, and monitoring of drug efficacy and safety); Regulation of drug manufacturing, importation, and distribution; Regulation & Control of drug promotion and information. Adverse drug reaction (ADR) monitoring. Licensing of premises, persons and practices. Main goal of drug regulation is to guarantee the safety, efficacy and quality of drugs available to public. KEY FUNCTIONS OF DRUG REGULATORY AGENCY : 5

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The drug regulation consists of: 1. Drug Laws 2. Drug Regulatory Agencies 3. Drug Regulatory Boards 4. Quality Control 5. Drug Information Centers etc. 6

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DRUGS REGULATORY SYSTEM IN INDIA 7

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Drugs and Health is in concurrent list of Indian Constitution It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940 . MAIN BODIES: Central Drug Standard Control Organization (CDSCO) Ministry Of Health & Family Welfare (MHFW) Indian Council Of Medical Research (ICMR) Indian Pharmaceutical Association (IPA) Drug Technical Advisory Board (DTAB) Central Drug Testing Laboratory (CDTL) Indian Pharmacopoeia Commission (IPC) National Pharmaceutical Pricing Authority (NPPA) 8

INDIA – WELL DEFINED DRUG REGULATORY SYSTEM Govt. of india:

Ministry of Health and Family Welfare DGHS CDSCO DCGI INDIA – WELL DEFINED DRUG REGULATORY SYSTEM Govt. of india DTAB Enforcement & GMP audit Div Quality Control Division – CDTL Registration Div New Drug Div Pharmacovigilance Trainings 9

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APPROVAL OF INVESTIGATIONAL NEW DRUG (IND) 10

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11 CENTRAL LICENSING

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14 Functions undertaken by Central Government Statutory function Laying down standards of drugs, cosmetics, diagnostics and devices. Laying down regulatory measures, amendments to Acts and Rules. To regulate market authorization of new drugs. To regulate clinical research in India To approve licenses to manufacture certain categories of drugs as Central Licence Approving Authority i.e. for Blood Banks, Large Volume Parenterals and Vaccines & Sera. To regulate the standards of imported drugs . Work relating to the Drugs Technical Advisory Board ( DTAB ) and Drugs Consultative Committee (DCC). Testing of drugs by Central Drugs Labs. Publication of Indian Pharmacopoeia .

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15 National Institute of Health and Family Welfare (NIHFW) NIHFW is an Apex Technical Institute, funded by Ministry of Health and Family Welfare , for promotion of health and family welfare programmers in the country through education, training, research, evaluation, consultancy and specialized services. The NIHFW was established on March 9, 1977 by a merger of the National Institute of Health Administration and Education (NIHAE) with the National Institute of Family Planning (NIFP).

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16 List of Governing Body Members of NIHFW 18 members 1 Chairman (ex-officio) 1 Vice Chairman (ex-officio) 9 Member ( ex-officio) 6 Member 1 Member Secretary (ex-officio)

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17 ACTIVITIES AND RESPONSIBILITIES : Measuring weight of children to assess the nutritional status. Assessment of diseases like level of anemia. Testing of food material like cooking salt for level iodine. To release fund on the advice of the Ministry. It is responsible for all governmental programs relating to family planning in India.

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18 STRUCTURE AND ORGANIZATION : Union Health Minister Governing Body Scientific Advisory Board Scientific Advisory Groups Expert Groups Scientific Advisory Committee Steering Committee Task Forces

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19 ACTIVITIES AND RESPONSIBILITIES : Extramural research is promoted by ICMR by establishing Centers for Advanced Research in different research areas. The ICMR also funds task force studies which emphasize a time-bound, goal-oriented approach. 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. In the context of the changing public health scene. Balancing of research efforts between different competing fields, especially when resources are severely limited, is a typical problem encountered in the management of medical research, particularly in developing countries.

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20 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 The Board shall consist of the following members, 18 Members 10 ex-officio Members 5 Nominated Members 5 Elected Members

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21 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, make bye-laws fixing a quorum and regulating its own procedure .

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22 CENTRAL DRUG TESTING LABORATORY (CDTL) The central drug laboratory, Kolkata is national statutory laboratory of the government of India for quality control of drug and cosmetic and established under the D&C act ,1940. Oldest quality control laboratory of the drug control authorities in India. Function under the director general of Health Services in the Ministry of Health and Family Welfare.

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23 FUNCTIONS UNDER TAKEN: Statutory Function : To Act as an Appellate authority. To function as Government Analyst for such states who do not have their own testing facilities. Analytical quality control of majority of the imported drugs. Analytical quality control of drug formulations manufactured within the country on behalf of the Central & State Drug standard control organization Other Functions: Procurement, establishment, maintenance, storage and distribution of I.P & International Reference standards. Preparation and standardization of I.P. reference standards against USP, BP primary standards. To undertake analytical research in standardization and methodology development of drug.

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24 COMPOSITION : Indian Pharmacopoeia Commission (IPC) General Body 19 Members Governing Body 10 Members Scientific Body 23 Experts CIPL Lab IPC Secretariat Indian Pharmacopoeia was prepared by Indian Pharmacopoeia Commission(IPC)

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25 ACTIVITIES AND RESPONSIBILITIES: Development of comprehensive monographs. Accord priority to monographs of drugs included in the national Essential Drug List and their dosage forms. Preparation of monograph for products that have normally been in the market for not less than 2 years. Collaborate with pharmacopoeias like the BP, USP, JP and International Pharmacopoeia with a view to harmonizing with global standards.

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26 Drug regulatory agencies in US

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27 AGENCIES The Food and Drug Administration (FDA) National Institutes of Health (NIH) Centers for Disease Control and Prevention Department of Health and Human Services (DHHS) Fed World - US Government Information National Center for Complementary and Alternative Medicine (NCCAM) National Center for Infectious Diseases (NCID) National Library of Medicine National Science Foundation Office of Disease Prevention

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28 The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices. FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002

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29 History 1927 — The "Bureau of Chemistry" is reorganized into two separate entities. Regulatory functions are located in the "Food, Drug, and Insecticide Administration", and nonregulatory research is located in the "Bureau of Chemistry and Soils". 1930 — The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.

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30 Mission The Food and Drug Modernization Act states that the FDA has 4 roles: To promote health by reviewing research and approving new products To ensure foods and drugs are safe and properly labeled To work with other nations to “reduce the burden of regulation” To cooperate with scientific experts and consumers to effectively carry out these obligations

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31 Organization The agency currently has roughly 9,500 full-time employees and is headquartered in Rockville, Maryland. The agency’s total budget in financial year 2002 was about $1.4 billion (the federal government’s financial year begins in September). The FDA is led by the Commissioner of Food and Drugs, who is appointed by the President and confirmed by the Senate. Dr. Mark McClellan, a physician with a doctorate in economics, was nominated to be commissioner by President George W. Bush in September 2002 and confirmed by the Senate in October

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33 FDA is responsible for Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; Assuring human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective Protecting the public from electronic product radiation Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products Advancing the public health by helping to speed product innovations Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health Initiation of a Recall. Includes voluntary, FDA requested, and FDA mandated.

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34 What doesn’t FDA regulate? FDA does not regulate: advertising (except for prescription drugs, medical devices, and tobacco products) alcoholic beverages illegal drugs of abuse, health insurance meat and poultry (except for game meats, such as venison, ostrich, and snake)

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35 The National Institutes of Health traces its roots to 1887, when a one-room laboratory was created within the Marine Hospital Service (MHS) , predecessor agency to the U.S. Public Health Service (PHS). The MHS had been established in 1798 to provide for the medical care of merchant seamen. In the 1880s, the MHS had been charged by Congress with examining passengers on arriving ships for clinical signs of infectious diseases, especially for the dreaded diseases cholera and yellow fever, in order to prevent epidemics.

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36 Mission NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The goals of the agency are: to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health; to develop, maintain, and renew scientific human and physical resources that will ensure the Nation's capability to prevent disease; to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science

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37 Drug regulatory agencies in J apan

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38 A gencies Ministry of Health and Welfare National Institute of Infectious Diseases National Institute of Health Sciences

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39 History In January 1938 , the Ministry of Health and Welfare was established by integrating the administrations of the Sanitary Bureau and the Social Affairs Bureau in the Ministry of Home Affairs. In September 1947 The Ministry of Labour was established by integrating labour administrations that had previously been conducted by the Ministry of Health and Welfare.

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40 Make a policy regarding Health and medical care-health, food, medical care, health insurance Children and childrearing Long term care, health and welfare services Employment security, labour Pension Other policy areas-international affairs, research project

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41 MHLW IN JAPAN The Ministry of Health, Labor, and Welfare (MHLW) was established by a merger of the Ministry of Health and Welfare (MHW) and the Ministry of Labor, on January 6, 2001. The MHLW, which was originally established in 1938, has been in charge of the improvement and promotion of social welfare, social security and public health, and the new organization has the same tasks. It consists of the ministry proper, affiliated institutions, councils, local branches, and an external organization.

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42 MHLW Social insurance agency Ministry proper Minister’s secretariat Heath policy bureau Heath service bureau PFSB Social welfare & war victim’s relief bureau Health and welfare bureau for elderly Equal employment children & family bureau Insurance bureau Pension bureau Director general for policy planning

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43 Social Welfare : Services for elderly people Services for persons with disabilities Social Security : Pension systems that will ensure income in elderly age Long term insurance to provide nursing care services Public assistance systems that guarantee minimum standards . FUNCTION OF MHLW

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44 Public Hygiene : Appropriate medical services for diseases & injuries Ensuring the safety of food, Water and medical supplies Research into health science in order to make technological advances Maternal and child health Job Security : Promotion of employment Employment of elderly people Employment of persons with disabilities Management of the employment insurance system

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45 Working Environment : Policy planning to improve the working environment Policy planning to ensure the health and safety of workers Measurement to secure equal opportunity, equal treatment Measures to support the harmonization of working and family life Management of the worker’s compensation system

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46 Human Resources Development : Promotion of human resources development that reacts to changes in the industrial system Encouragement of worker’s skill development under their own initiative Development of skilled human resources that support industrial progress

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47 Drug regulatory agencies in EU

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48 AGENCIES EU Legislation - Eudralex European Directorate for the Quality of Medicines and Healthcare (EDQM) European Medicines Agency (EMEA) Heads of Medicines Agencies (HMA)

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49 European Directorate For The Quality Of Medicines & Health Care The EDQM (Council of Europe) is a key European Organisation involved in Harmonisation & Co-ordination of Standardisation , Regulation & Quality Control of Medicines, Blood Transfusion, Organ Transplantation, Pharmaceuticals and Pharmaceutical Care. In 1996 The European Directorate for the Quality of Medicines (EDQM) is created.

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50 MISSION To contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect human and animal health by: Establishing and providing official standards which apply to the manufacture and quality control of medicines in all signatory States of the "Convention on the Elaboration of a European Pharmacopoeia" and beyond; Ensuring the application of these official standards to substances used in the production of medicines; Co- ordinating a network of Official Medicines Control Laboratories (OMCL) to collaborate and share expertise among Member States and to effectively use limited resources; Proposing ethical, safety and quality standards: - for the collection, preparation, storage, distribution and appropriate use of blood components in blood transfusion; - for the transplantation of organs, tissues and cells;

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51 ORGANIZATION CHART

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52 EMA EMA is a European agency for the evaluation of medicinal product. EMA was set up in 1995. From 1995 to 2004, EMA was known as European agency for the evaluation of medicinal product. The European Medicines Agency (EMA) is a decentralized body of the European Union, located in London Mission: to foster scientific excellence in evaluation and supervision of medicines.

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53 office of executive director Executive director Legal service Senior medical officer Internal audit Information and communicate ion veterinary medicines and product data management Patient health protection Human medicines development and evaluation

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54 ACTIVITIES OF EMA provides independent, science-based recommendations on the quality, safety and efficacy of medicines. applies efficient and transparent evaluation procedures to help bring new medicines to the market. implements measures for continuously supervising the quality, safety and efficacy of authorised medicines. provides scientific advice to stimulate the development and improve the availability of innovative new medicines;

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55 recommends safe limits for residues of veterinary medicines used in food-producing animals. publishes impartial and comprehensible information about medicines and their use; develops best practice for medicines evaluation and supervision in Europe, and contributes alongside the Member States and the European Commission to the harmonization of regulatory standards at the international level.

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57 The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990 , ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonization for better global health can be realized worldwide. ICH's mission is to achieve greater harmonization to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner .

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58 HISTORY The Need to Harmonise The realization that it was important to have an independent evaluation of medicinal products before they are allowed on the market However in many cases the realization was driven by tragedies, such as that with thalidomide in Europe in the 1960s. For most countries, whether or not they had initiated product registration controls earlier, the 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products

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59 Initiation of ICH Harmonization of regulatory requirements was pioneered by the European Community (EC), in the 1980s , as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonization. It was, however, at the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989 , that specific plans for action began to materialize. Soon afterwards, the authorities approached IFPMA to discuss a joint regulatory-industry initiative on international harmonization, and ICH was conceived. The birth of ICH took place at a meeting in April 1990 , hosted by EFPIA in Brussels

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60 Objectives: Better consumer information. Post marketing safety. New product review. Keep watch on safe manufacturing and handling. Monitoring for new risk. Standardization and regulation. Enforcement and corrective problem.

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61 Mission ICH’s mission is to make recommendations towards achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines. To maintain a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, USA and Japan in order to ensure a more timely introduction of new medicinal products, and their availability to patients;

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62 To contribute to the protection of public health from an international perspective; To monitor and update harmonised technical requirements leading to a greater mutual acceptance of research and development data; To avoid divergent future requirements through harmonization of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products; To facilitate the adoption of new or improved technical research and development approaches which update or replace current practices, where these permit a more economical use of human, animal and material resources, without compromising safety; To facilitate the dissemination and communication of information on harmonised guidelines and their use such as to encourage the implementation and integration of common standards.

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63 ICH Structure The ICH is composed of the following components: Steering Committee, ICH Secretariat, Observers, Expert Working Group (EWG).

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64 The ICH receives support from the following organizations: In the European Union, the European Agency for the Evaluation of Medicinal Products (EMEA) and the European Federation of Pharmaceutical Industries’ Associations (EFPIA) represent both regulatory agencies and industry associations, respectively; In the United States, the Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America (PhRMA) are included; and In Japan, the Ministry of Health, Labour, and Welfare (MHLW1) and the Japan Pharmaceutical Manufacturers Association (JPMA) are the respective organizations.

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65 How does ICH work ? ICH operates through the ICH Steering Committee with administrative support from the ICH Secretariat and ICH Coordinators. The Steering Committee meets at least twice a year, rotating meeting sites among the three regions. The topics identified for harmonization by the Steering Committee are selected. Working Groups also meet during the same week as the Steering Committee meetings and report on their progress to the Committee. Considerable work also occurs between meetings.

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66 Current ICH Terms of Reference (2000) To maintain a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, USA and Japan in order to ensure a more timely introduction of new medicinal products, and their availability to patients; To contribute to the protection of public health from an international perspective; To monitor and update harmonized technical requirements leading to a greater mutual acceptance of research and development data; To avoid divergent future requirements through harmonization of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products;

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67 ICH Guidelines The ICH topics are divided into four major categories: Quality topics, Safety topics, Efficacy topics, Multidisciplinary topics.

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69 Reference: www.cdsco.nic.in www.mohfw.nic.in www.health.cg.gov.in www.icmr.nic.in www.dst.gov.in http://www.nppaindia.nic.in/index1.html http://www.nihfw.org/ http://indianmedicine.nic.in/ http://www.nih.gov/ http://www.mhlw.go.jp/ http://www.edqm.eu http://www.ich.org http://www.infoahmedabad.com/2009/11/gujarat-fdca-to-set-up-6-more-district.html

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