regulatory issues

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Science-Technology

Published on March 22, 2012

Author: dixitkumarrakesh

Source: authorstream.com

Regulatory Issues: Regulatory Issues Prof. R. K. Dixit Pharmacology and Therapeutics C. S. M. Medical University Lucknow PowerPoint Presentation: Why is Regulatory Affairs Needed? Drug development and commercialization should be highly regulated Things change....constantly! PowerPoint Presentation: What is Regulatory Affairs? Regulatory Affairs: Is a unique mix of science and management to achieve a commercially important goal within a drug-development organization. Touches everything relating to drugs from the earliest non-clinical studies, through development, into routine manufacture and marketing. Can add significant impact for patients and drug companies. PowerPoint Presentation: Regulations National Laws (e.g. Indian drug and cosmetic act, UK - Medicines Act) International Guidelines (ICH) Indian scenario…………..: Indian scenario………….. To have comprehensive legislation, the Indian Government appointed a Drug Enquiry Committee under the Chairmanship of Lt. Co. R.N. Chopra in 1931. For ways and means to control production and sale of Drugs and Pharmaceuticals in the interest of public health. PowerPoint Presentation: • The Drugs and Cosmetics Act was passed in 1940, to regulate the import, manufacture, distribution and sale of drugs in India. PowerPoint Presentation: In 1985 the Narcotic Drugs and Psychotropic Substances Act was enacted PowerPoint Presentation: At present the following Acts and Rules regulate the manufacture, export and clinical research of Drugs and Cosmetics in India. • A) Drugs and Cosmetics Act, 1940. • B) Drugs and Cosmetics Rules, 1945. • C) Pharmacy Act, 1948. • D) Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 • E) Narcotic Drugs and Psychotropic Substances Act, 1985. • F) Medicinal and Toilet Preparations (Excise Duties) Act, 1955. • G) Drugs (Price Control) Order, 1955 under Essential Commodities Act, 1955. PowerPoint Presentation: There are some other laws which have a bearing on manufacture, distribution and sale of Drugs and Cosmetics in India. • A) Industrial Disputes Act, 1947. • B) Industrial Development and Regulation Act, 1951. • C) Trade and Merchandise Marks Act, 1999. PowerPoint Presentation: • D) Indian Patents and Design Act, 1970 • E) Factories Act, 1948. • Pharmacy Act, 1948: It was passed in 1948 and was amended in 1959, 1976, 1982,1984 and 1986. PowerPoint Presentation: Some other laws which are connected to Drugs are: • A) Law of Torts and Consumer Protection Act, 1986 • B) Monopolies and Restrictive Trade Protection Act, 1967 and Competition Act, 2002. PowerPoint Presentation: • C) Import and Exports (Control) Act, 1947 which was repealed by Foreign Trade Development Regulation Act, 1992. • D) Indian Contract Act, 1872 • E) Sale of Goods Act, 1930. • F) Drug Policy. • G) Pharmaceutical Policy,2002 • H) Drugs (Prices Control) Order, 1995 PowerPoint Presentation: • i) Supreme Court Ruling on Price Control on seven bulk drugs. • J) Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998. • K) Infant Milk substitutes, Feeding-Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992. PowerPoint Presentation: • L) Infant Milk Substitutes, Feeding-Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Rules, 1993. • M) Medicinal and Toilet Preparations (Excise Duties) Act, 1955 • N) Epidemic Diseases Act, 1897 PowerPoint Presentation: • 0) Medical Termination of Pregnancy Act, 1971. • P) Medical Termination of Pregnancy Rules, 2003 • Q) Medical Termination of Pregnancy Regulations,2003. • R) Clinical Thermometers (Quality Control) Order, 2001 PowerPoint Presentation: • S) Pre-Conception and Pre-Natal Diagnostic Techniques ( Prohibition of sex Selection) Act, 1994. • T) Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of sex Selection) Rules, 1996. • U) Opium Act, 1878. • V) Central Opium Rules, 1934 PowerPoint Presentation: • W) Indian Penal Code, 1860 • X) Criminal Procedure Code, 1973. THE DRUGS AND COSMETICS ACT, 1940: THE DRUGS AND COSMETICS ACT, 1940 • The object of the Act is to regulate the import, manufacture, distribution and sale of drugs and cosmetics. • The object of the Act is to impose more stringent penalties on the anti social elements indulging in the manufacture or sale of adulterated or spurious drugs or drugs not of standard quality which are likely to cause death or grievous hurt to the user. PowerPoint Presentation: Includes all the disciplines relating to drug development and commercialization Science (Pharmaceutical, Non-clinical, Clinical) Commercial (Marketing, Manufacture, Supply) Resources (Funding, Manpower) International Regulatory Issues: International Regulatory Issues Some steps…: Some steps… Nuremberg code Declaration of Helsinki Belmont Report Council for International Organization of Medical Sciences (CIOMS) International Conference on Harmonization (ICH)-GCP guidelines European union F.D.A Nuremberg Code: Nuremberg Code The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War. PowerPoint Presentation: The Nuremberg Trials were a series of military tribunals, held by the main victorious Allied forces of World War II, most notable for the prosecution of prominent members of the political, military, and economic leadership of the defeated Nazi Germany. The trials were held in the city of Nuremberg, Germany, in 1945-46. PowerPoint Presentation: NUREMBERG CODE The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. PowerPoint Presentation: This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment ; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. PowerPoint Presentation: The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. PowerPoint Presentation: The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment . The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. PowerPoint Presentation: No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death . PowerPoint Presentation: The experiment should be conducted only by scientifically qualified persons . The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. PowerPoint Presentation: During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage , if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. Declaration of Helsinki : Declaration of Helsinki The Declaration of Helsinki was developed by the World Medical Association (WMA), as a set of ethical principles for the medical community regarding human experimentation, and is widely regarded as the cornerstone document of human research ethics. PowerPoint Presentation: The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone six revisions (the most recent at the General Assembly in October 2008) and two clarifications, growing considerably in length from 11 to 32 paragraphs. The Declaration is an important document in the history of research ethics as the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents. PowerPoint Presentation: It is not a legally binding instrument in international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations . Its role was described by a Brazilian forum in 2000 in these words " Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity " . PowerPoint Presentation: It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfilment of this mission. World Medical Association binds the physician with the words, “ The health of my patient will be my first consideration” . PowerPoint Presentation: The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the etiology and pathogenesis of disease . In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research. PowerPoint Presentation: A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available. Basic Principles : Basic Principles Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance. PowerPoint Presentation: Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject. PowerPoint Presentation: Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject. PowerPoint Presentation: Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results . Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication . PowerPoint Presentation: In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw visor her consent to participation at any time . The physician should then obtain the subject's freely given informed consent, preferably inheriting. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who isn't engaged in the investigation and who is completely independent of this official relationship. PowerPoint Presentation: In case of legal incompetence , informed consent should be obtained from the legal guardian in accordance with national legislation . Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present declaration are complied with. PowerPoint Presentation: In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure , if in his or her judgement it offers hope of saving life, re-establishing health or alleviating suffering. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods. In any medical study, every patient- including those of a control group, if any- should be assured of the best proven diagnostic and therapeutic method . PowerPoint Presentation: The refusal of the patient to participate in a study must never interfere with the physician-patient relationship . If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (1, 2). The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient. Non-Therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research) : Non-Therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research) In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out. The subjects should be volunteers- either healthy persons or patients for whom the experimental design is not related to the patient's illness. PowerPoint Presentation: The investigator or the investigating team should discontinue the research if in his/her or their judgment it may, if continued, be harmful to the individual. In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject. Controversies : Controversies The US FDA rejected the 2000 and subsequent revisions, only recognizing the third (1989) revision (Wolinsky 2006), and in 2006 announced it would eliminate all reference to the Declaration. After consultation, which included expressions of concern, a final rule was issued on April 28, 2008 replacing the Declaration of Helsinki with Good Clinical Practice effective October 2008. This has raised a number of concerns regarding the apparent weakening of protections for research subjects outside the United States. Belmont Report : Belmont Report The Belmont Report is a report created by the former United States Department of Health, Education, and Welfare (which was renamed to Health and Human Services ) entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," authored by Dan Harms. The report was created on April 18, 1979 and gets its name from the Belmont Conference Center where the document was drafted. The conference center, once a part of the Smithsonian Institution, is in Elkridg, Maryland, 10 miles south of Baltimore, and is now operated by Howard Community College. History : History Prompted in part by problems arising from the Tuskegee Syphilis Study (1932–1972) and based on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978), the Department of Health, Education and Welfare (HEW) revised and expanded its regulations for the protection of human subjects 45 CFR part 46 in the late 1970s and early 1980s. In 1978, the Commission’s report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” was published. It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report. The three fundamental ethical principles for using any human subjects for research are :: The three fundamental ethical principles for using any human subjects for research are : Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception; Beneficence : The philosophy of " Do no harm " while maximizing benefits for the research project and minimizing risks to the research subjects; and Justice : ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally. PowerPoint Presentation: These principles remain the basis for the HHS human subject protection regulations. Today, the Belmont Report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations. Council for International Organizations of Medical Sciences : Council for International Organizations of Medical Sciences The Council for International Organizations of Medical Sciences (CIOMS) is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949. CIOMS serves the scientific interests of the international biomedical community in general and has been active in promulgating guidelines for the ethical conduct of research, among other activities. Guidelines for human subjects : Guidelines for human subjects The International Ethical Guidelines for Biomedical Research Involving Human Subjects , sometimes informally referred to as CIOMS Guidelines , is a set of ethical principles regarding human experimentation created in 1993 by CIOMS and updated in 2002. These 21 guidelines (15 in the original report) address issues including Informed consent, standards for external review, recruitment of participants, and more. The Guidelines are general instructions and principles of ethical biomedical research. Guidelines for animal testing: Guidelines for animal testing The Council has also issued International Guiding Principles for Biomedical Research Involving Animals . PowerPoint Presentation: ICH History of ICH : History of ICH Beating the rising costs of health care and research and development Minimize delays in making new medicines available to patients Urgent need felt to rationalize and harmonize regulation Meeting in 1988 between European Commission and European Federation of Pharmaceutical Industries Association (EFPIA) Similar initiatives in Japan and US History of ICH: History of ICH ICH process (the International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use) initiated ICH Steering Committee set up in April 1990 at Brussels Regularly meeting at least twice an year at either US, Japan or Europe Basic principles guiding the ICH process: Basic principles guiding the ICH process Development of scientific consensus through discussions between regulatory and industry experts Wide consultation of the draft consensus documents , through normal regulatory channels, before a harmonized text is adopted Commitment by regulatory parties to implement the ICH harmonized texts PowerPoint Presentation: Six party Expert Working Groups (EWGs) set up Scientific and technical aspects of each harmonization topic discussed through EWGs Terms of reference in ICH : Terms of reference in ICH Clearly defined and realistic objectives Eleven defined topics in ICH 1 Quality T1-T3 Safety T1-T4 Efficacy T1-T4 ICH STRUCTURE: ICH STRUCTURE Founder members European commission – EMEA European Federation of Pharmaceutical Industries and Associations (EFPIA) Ministry of Health, Labor and Welfare (MHLW), Japan Japan Pharmaceutical Manufacturers Association (JPMA) US Food and Drug Administration (FDA) Pharmaceutical Research and Manufacturers of America (PhRMA) PowerPoint Presentation: Observers World Health Organization (WHO) European Free Trade Area (EFTA) ICH Coordinators Each of six groups has a designated coordinator and other experts to reflect their views ICH Secretariat: ICH Secretariat ICH Secretariat is supported by International Federation of Pharmaceutical Manufacturer’s Association (IFPMA) Concerned with Preparation for meetings of the Steering Committee Technical documentation Coordination of the EWGs “Five step” Approach to ICH Process: “Five step” Approach to ICH Process Forum for dialogue between regulatory authorities and the pharmaceutical industry on the differences in the technical requirements for product registration Contribute to public health from international perspective Monitor and update harmonized technical requirements PowerPoint Presentation: Avoid divergent future requirements through harmonization of selected topics Facilitation of adoption of improved technical research and development approaches Initiation of ICH Harmonization Action: Initiation of ICH Harmonization Action Proposals for harmonization action Preparation of Concept Paper Selection of procedure Full ICH Process: Full ICH Process Topic Selection Proposals for new topics included as item in Steering committee Preliminary estimate made to decide whether the paper can be accommodated within ICH work program Concept paper also indicates the type of Expert Working group PowerPoint Presentation: Steering committee action Confirming the objectives and expected outcomes of the harmonization action Confirming the composition of EWG Setting a “target” timetable and action plan for the EWG (not exceeding 2 years) Steps in ICH process: Steps in ICH process Step 1 Consensus building Initial draft of the recommendation based on the Concept paper is circulated for comments and interim reports are made in each meeting of ICH steering committee If consensus is reached, step 2 is adopted; however, if no consensus is reached, experts decide either to amend the proposal or suspend the harmonization project PowerPoint Presentation: Step 2 Start of Regulatory Action Agreement by the Steering committee for proceeding to the next stage of regulatory consultation Document signed by all the six members indicating their assent PowerPoint Presentation: Step 3 Regulatory Action Guideline subject to regulatory consultation in three regions Published as a draft guideline in the EU and the Federal register; MHLW issues in Japan for internal and external consultation Three regulatory parties form a single harmonized text and a Regulatory Rapporteur obtains a final document PowerPoint Presentation: Step 4 Adoption of a Tripartite Harmonized Text Regulatory Rapporteur submits report to Steering committee Adoption of the text if both the industry and regulatory parties are satisfied If any party representing the industry has a problem, regulatory parties may suggest a revised version of the text to be submitted for further consultation PowerPoint Presentation: Step 5 Implementation Final step carried in accordance with regional /national procedures applying to other regulatory guidelines and requirements in USA, EU and in Japan Details of regulatory action taken along with dates of implementation reported back to the Steering Committee and published by the Secretariat ICH Topics: ICH Topics Divided into 4 major broad categories: Quality Safety Efficacy Multidisciplinary Quality: Quality Related to chemical and pharmaceutical quality assurance Q1- safety testing Q2- validation of analytical procedure Q3- impurity testing Q4- pharmacopoeias Q5- quality of biotechnological products Q6- specifications for test procedures Q7- good manufacturing practices Q8- pharmaceutical development Q9- quality risk management Q10- pharmaceutical quality system Safety : Safety Related to in vivo and in vitro preclinical studies S1- carcinogenicity testing S2- genotoxicity testing S3- toxicokinetics and pharmacokinetics S4- toxicity testing S5- reproductive toxicology S6- biotechnology products S7- pharmacology studies S8- immunotoxicology studies Efficacy : Efficacy Related to clinical studies in human subjects E1- exposure E2- clinical safety E3- study response E4- dose response studies E5- ethnic factors E6- good clinical practices E7- special population (geriatrics) E8/9/10-clinical trial design including biostatistics E11- special population (pediatrics) E15- pharmacogenomics Multidisciplinary : Multidisciplinary Topics which do not fit into any of the above categories M1- medical terminology M2- electronic standard for transmission of regulatory information (ESTRI) M3- non clinical studies for conduct of human clinical trials M4- common technical document M5- data elements and standards for drug dictionaries Future of ICH: Future of ICH Activities in future Implementation and maintaining existing guidelines Preventing disharmony Encourage scientific dialogue and harmonization in new areas (e.g. post marketing areas) Undertaking efforts towards global cooperation with non ICH countries (using modern techniques like video conferencing) PowerPoint Presentation: With the ICH process, efforts are aligned in a single direction to ensure that irrespective of the country, the data generated is of good quality and standard which can be accepted worldwide Food and Drug Administration : Food and Drug Administration PowerPoint Presentation: The Food and Drug Administration ( FDA or USFDA ) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics. PowerPoint Presentation: The FDA also enforces other laws, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. PowerPoint Presentation: The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services . The 21st and current Commissioner is Dr. Margaret A. Hamburg (since February 2009). PowerPoint Presentation: The FDA has its headquarters at Silver Spring, Maryland and has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. Organization : Organization The FDA comprises several offices and centers. There are Center for Biologics Evaluation and Research Center for Devices and Radiological Health (CDRH) Center for Drug Evaluation and Research (CDER) Center for Food Safety and Applied Nutrition Center for Tobacco Products Center for Veterinary Medicine National Center for Toxicological Research Office of Regulatory Affairs PowerPoint Presentation: Legal authority Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act , parts of the Controlled Substances Act , the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies. PowerPoint Presentation: Important enabling legislation for the FDA includes: 1902 – Biologics Control Act 1906 – Pure Food and Drug Act 1938 – Federal Food, Drug, and Cosmetic Act 1944 – Public Health Service Act 1951 – 1951 Food, Drug, and Cosmetics Act Amendments 1962 – 1962 Food, Drug, and Cosmetics Act Amendments 1966 – Fair Packaging and Labeling Act 1976 – Medical Device Regulation Act 1987 – Prescription Drug Marketing Act 1988 – Anti–drug Abuse Act 1990 – Nutrition Labeling and Education Act 1992 – Prescription Drug User Fee Act 1994 – Dietary Supplement Health and Education Act 1997 – Food and Drug Administration Modernization Act 2002 – Bioterrorism Act 2002 – Medical Device User Fee and Modernization Act 2003 – Animal Drug User Fee Act 2007 – Food and Drug Administration Amendments Act of 2007 2009 – Family Smoking Prevention and Tobacco Control Act 2010 – FDA Food Safety Modernization Act Regulatory programs : Regulatory programs The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483. EUROPEAN UNION: EUROPEAN UNION European Medicines Agency : European Medicines Agency The European Medicines Agency is a decentralized agency of the European Union, located in London . The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. Responsibilities: Responsibilities The Agency is responsible for the scientific evaluation of applications for European marketing authorizations for both human and veterinary medicines (centralized procedure). Under the centralized procedure, companies submit a single marketing-authorization application to the Agency. Once granted by the European Commission, a centralized (or ‘Community’) marketing authorization is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway). PowerPoint Presentation: All medicines for human and animal use derived from biotechnology and other high-tech processes must be approved via the centralized procedure. The same applies to all advanced-therapy medicines and human medicines intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, as well as to all designated orphan medicines intended for the treatment of rare diseases . PowerPoint Presentation: The Agency constantly monitors the safety of medicines through a pharmacovigilance network, and takes appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorized. PowerPoint Presentation: The Agency also plays a role in stimulating innovation and research in the pharmaceutical sector . The Agency gives scientific advice and other assistance to companies for the development of new medicines. It publishes guidelines on quality-, safety- and efficacy-testing requirements. A dedicated SME Office, established in 2005, provides special assistance to small and medium-sized enterprises. Scientific Committees: Scientific Committees Six scientific committees, composed of members of all EU and EEA-EFTA states, some including patients’ and doctors’ representatives, conduct the main scientific work of the Agency: CHMP - the Committee for Medicinal Products for Human Use CVMP - the Committee for Medicinal Products for Veterinary Use COMP - the Committee for Orphan Medicinal Products HMPC - the Committee on Herbal Medicinal Products PDCO - the Paediatric Committee CAT - the Committee for Advanced Therapies Working parties : Working parties The Committee for Medicinal Products for Human Use (CHMP) establishes a number of working parties at the beginning of each three-year mandate. These working parties have expertise in a particular scientific field, and are composed of members selected from the European experts list maintained by the Agency. The CHMP consults its working parties on scientific issues relating to their particular field of expertise, and delegates certain tasks to them associated with the scientific evaluation of marketing authorization applications or drafting and revision of scientific guidance documents. PowerPoint Presentation: The current CHMP standing working parties are: Patients' and Consumers' Working Party Pharmacovigilance Working Party Quality Working Party Safety Working Party Scientific Advice Working Party Temporary working parties : Temporary working parties Whenever work of a temporary or an ad-hoc nature is required, the CHMP may establish a temporary working party to conduct it. The work of these parties generally involves the preparation of proposals on a specific scientific topic, the preparation of responses to specific questions raised by the CHMP, and the drafting or revision of guidelines relating to the scientific field in which the temporary working party has special competence. PowerPoint Presentation: The current CHMP temporary working parties are: Biosimilar Medicinal Products Working Party Biostatistics Working Party Blood Products Working Party Cardiovascular Working Party Central Nervous System Working Party Infectious Diseases Working Party Oncology Working Party Pharmacogenomics Working Party Pharmacokinetics Working Party Rheumatology/Immunology Working Party Vaccines Working Party Drafting groups : Drafting groups Drafting groups are created whenever a process for reviewing or developing a particular guideline is adopted, and the topic does not fall within the remit of any of the existing working parties. The current drafting groups are: Gastroenterology Drafting Group Radiopharmaceuticals Drafting Group Respiratory Drafting Group Urology Drafting Group Scientific advisory groups : Scientific advisory groups The CHMP establishes scientific advisory groups to provide advice in connection with the evaluation of specific types of medicines or treatments . They consist of European experts selected according to the particular expertise required on the basis of nominations from the CHMP or the Agency. The current CHMP scientific advisory groups are: Scientific Advisory Group on Cardiovascular Issues Scientific Advisory Group on Anti-infectives Scientific Advisory Group on Diabetes/Endocrinology Scientific Advisory Group on Diagnostics Scientific Advisory Group on HIV/Viral Diseases Scientific Advisory Group on Neurology Scientific Advisory Group on Oncology Scientific Advisory Group on Psychiatry PowerPoint Presentation: The Agency works with a network of over 4,500 'European experts' who serve as members of the Agency's scientific committees, working parties or scientific assessment teams. These experts are made available to the Agency by the national competent authorities of the EU and EFTA states. PowerPoint Presentation: The Agency can be considered as the 'hub' of a European medicines network comprising over 40 national competent authorities in 30 EU and EEA-EFTA countries, the European Commission, the European Parliament and a number of other decentralized EU agencies. The Agency works closely with its European partners to build the best possible regulatory system for medicines for Europe and protect the health of its citizens. PowerPoint Presentation: The Agency is also involved in referral or arbitration procedures relating to medicines that are approved or under consideration by Member States in non-centralised authorisation procedures. PowerPoint Presentation: The Agency is headed by an Executive Director and has a secretariat of approximately 530 full-time staff (2009 figure), . The Management Board is the supervisory body of the Agency, responsible, in particular, for budgetary matters. 35-member Board sets the Agency’s budget, approves the annual work programme and is responsible for ensuring that the Agency works effectively and cooperates successfully with partner organisations across the EU and beyond. All members are required to make an annual declaration of any direct or indirect interests they have in the pharmaceutical industry. These declarations are published on the Agency's public website. And what EMEA do not do : And what EMEA do not do Evaluate all medicines in use in the European Union Thousands of other medicines that do not fall within this scope are marketed in the European Union either in individual Member States, in accordance with their national authorisation procedures, or in multiple Member States through the decentralised or mutual-recognition procedures. Research or develop medicines The Agency does not research or develop medicines, nor does it operate laboratories on its premises or elsewhere for such work. Evaluate the pricing or availability of medicines in individual countries The Agency is not responsible for reviewing pricing issues or for making decisions on the availability of medicines in EU or EEA-EFTA countries through their national health systems. These issues are dealt with by the national government or health authorities of individual countries. PowerPoint Presentation: Establish ethical codes in relation to the development of medicines or evaluate applications based on ethical considerations Issues relating to ethics are established through legislation and directives set by the European Parliament, based on proposals from the European Commission, which in turn is advised by the European Group on Ethics in Science and New Technologies . Guiding principles : Guiding principles strongly committed to public and animal health. make independent recommendations based on scientific evidence, using state-of-the-art knowledge and expertise. support research and innovation to stimulate the development of better medicines. value the contribution of partners and stakeholders to work. assure continual improvement of processes and procedures, in accordance with recognized quality standards. adhere to high standards of professional and personal integrity. communicate in an open, transparent manner with all partners, stakeholders and colleagues. promote the well-being, motivation and ongoing professional development of every member of the Agency. Thanks: Thanks

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