Regulatory Authorities

European Union

EuroReg


In the EU, medicines can be authorised by the Centralised Authorisation Procedure (CAP) or by individual Member States' NCAs as part of the Decentralised Procedure (DCP). EMA is responsible for the CAP for human and veterinary medicines. This results in a single marketing authorisation valid in all EU countries, including the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

In addition, EMA has a number of working parties and coordination groups, which are consulted by EMA’s scientific committees on issues in their particular field of expertise. They consist of national (European Union) experts, with expertise in a particular scientific field and provide advice.

The scientific committees of EMA’s working parties are:


EMA’s coordination groups are:

 

  • European Directorate for The Quality of Medicines and Health Care, European Pharmacopoeia (EDQM)
    The EDQM is a Directorate of the Council of Europe created in 1964 that protects public health by enabling the development, supporting the implementation, and monitoring the application of quality standards for safe medicines and their safe use, including blood and blood products.

    The European Pharmacopoeia standards
    The EDQM is a Directorate of the Council of Europe created in 1964 that protects public health by enabling the development, supporting the implementation, and monitoring the application of quality standards for safe medicines and their safe use. They define quality and quantitative composition of medicines, their components and tests. The European Pharmacopoeia standards are legally binding in Council of Europe Member States.

  • National Competent Authorities (NCAs) of EU Member States
    Evaluation and supervision of medicines and public health protection is also performed at the national level by the Member States’ NCAs. This includes authorizations of medicines on a national level through the National or Decentralized Authorization Procedure (DCP) formedicines not authorized via the Centralised Authorisation Procedure (CAP). Authorisations of medicines in one Member State make it easier to obtain marketing authorisations in another or several other Member States. In this case, one or more NCAs to mutually recognise the authorization already granted in one Member state via the Mutual Recognition Procedure (MRP).

  • Both the EC and EMA maintain lists of NCAs on their websites.

    • Austria (Austrian Agency for Health and Food Safety - AGES)

    • Belgium (Federal Agency for Medicines and Health Products - FAMHP)

    • Bulgaria (Bulgarian Drug Agency - BDA)

    • Croatia (Agency for Medicinal Products and Medical Devices - HALMED)

    • Cyprus (Ministry of Health Pharmaceutical Services - MHPS)

    • Czech Republic (State Institute for Drug Control - SUKL)

    • Denmark (Danish Health and Medicines Authority - DKMA)

    • Estonia (State Agency of Medicines)

    • Finland (Finnish Medicines Agency - fimea)

    • France (National Agency for the Safety of Medicine and Health Products - ansm)

    • Germany (Federal Institute for Drugs and Medical Devices - BfArM)

    • Germany (Paul-Ehrlich-Institut - PEI)

    • Greece (National Organization for Medicines - EOF)

    • Hungary (National Institute of Pharmacy - OGYI)

    • Iceland (Icelandic Medicines Agency - IMA)

    • Ireland (Irish Medicines Board - IMB)

    • Italy (Italian Medicines Agency - AIFA)

    • Latvia (State Agency of Medicines - ZVA)

    • Liechtenstein (Office of Health/Department of Pharmaceuticals - LLV)

    • Lithuania (State Medicines Control Agency - VVKT)

    • Luxembourg (Ministry of Health)

    • Malta (Medicines Authority)

    • Netherlands (Healthcare Inspectorate - IGZ)

    • Netherlands (Medicines Evaluation Board - CBG-MEB)

    • Norway (Norwegian Medicines Agency)

    • Poland (Main Pharmaceutical Inspectorate - GIF)

    • Poland (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products - URPL)

    • Portugal (National Authority of Medicines and Health Products - infarmed)

    • Romania (National Medicines Agency - ANM)

    • Slovakia (State Institute for Drug Control -SUKL)

    • Slovenia (Agency for Medicinal Products and Medical Devices - jazmp)

    • Spain (Spanish Agency for Medicines and Healthcare Products - AEMPS)

    • Sweden (Medical Products Agency - MPA)

    • Switzerland (Swissmedic)

    • Turkey (Ministry of Health - IEGM)

    • United Kingdom (Medicines and Healthcare Products Regulatory Agency - MHRA)

United States

  • Department of Health and Human Services (HHS)
    It is the mission of HHS to enhance and protect the health and well-being of all Americans by providing for effective health and human services and fostering advances in medicine, public health, and social services. HHS has 11 operating divisions, including eight agencies in the U.S. Public Health Service (USPHS) and three human services agencies. These divisions administer a wide variety of health and human services and conduct life-saving research for the nation, protecting and serving all Americans. The Office of the Secretary (OS), HHS’s chief policy officer and general manager, administers and oversees the organization, its programs, and its activities. The Deputy Secretary and a number of Assistant Secretaries and Offices support OS.


    • Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) 
      ACBTSA provides advice to the Secretary and to the Assistant Secretary for Health. ACBTSA advises on a range of policy issues to include definition of public health parameters around safety and availability of blood and blood products and broad public health, ethical and legal issues related to transfusion and transplantation safety. ACBTSA has met regularly since its establishment in 1997. The PPTA Vice President, Global Regulatory Policy, serves on ACBTSA. The most recent public meeting was on Nov. 28-29, 2016.

  • Centers for Disease Control and Prevention (CDC)
    CDC is one of the major operating components of HHS. CDC works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same. CDC increases the health security of our nation. As the nation’s health protection agency, CDC saves lives and protects people from health threats. To accomplish its mission, CDC conducts critical science and provides health information that protects our nation against expensive and dangerous health threats, and responds when these arise.

  • Food and Drug Administration (FDA)
    FDA is an agency within HHS. FDA's organization consists of the Office of the Commissioner (OC) and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. The Office of Medical Products and Tobacco provides advice and counsel to the Commissioner on all medical product and tobacco-related programs and issues. The Center for Biologics Evaluation and Research (CBER) is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products. 

    • Blood Products Advisory Committee (BPAC)
      BPAC reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility, and advises CBER of its findings. BPAC consists of a core of 17 voting members including the Chair. The core of the voting members includes one technically qualified member who is identified with consumer interest. In addition to the voting members, BPAC includes one nonvoting member who is identified with industry interest. Toby L. Simon, M.D., Senior Medical Director, Plasma and Plasma Safety, Plasma Research and Development/CSL Plasma, CSL Behring, served as the industry non-voting representative from 2012 through Nov. 18, 2016.. The most recent public meeting was on Nov. 17-18, 2016.

    • Risk Communication Advisory Committee (RCAC)

      RCAC advises the OC on methods to effectively communicate risk associated with products regulated by FDA and in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. It also reviews and evaluates research relevant to such communication to the public by both FDA and other entities, and facilities interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products. RCAC consists of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in fields such as social marketing, health literacy, and other relevant areas. Members include experts on risk communication, experts on emerging post market drug risk and individuals knowledgeable about and experienced in the work of patient, consumer, and health professional organizations. The most recent public meeting was on Nov. 7, 2016.

    • Science Board to FDA
      The Science Board provides advice to the OC on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science; and input into the Agency’s research agenda; and on upgrading its scientific and research facilities and training opportunities. It also provides, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The Science Board consists of a core of 21 voting members including a Chair and Co-Chair.  The members, Chair and Co-Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of food science, safety, and nutrition; chemistry; pharmacology; translational and clinical medicine and research; toxicology; biostatistics; medical devices; imaging; robotics; cell and tissue based products; regenerative medicine; public health and epidemiology; international health and regulation; product safety;  product manufacturing sciences and quality; and other scientific areas relevant to FDA regulated products such as systems biology, informatics, nanotechnology, and combination products. The most recent public meeting was on Nov. 15, 2016.

    • Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC)
      TSEAC was terminated on June 9, 2016. All topics previously brought before TSEAC are now addressed by FDA’s other advisory committees, such as BPAC. TSEAC reviewed and evaluated available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health as determined by CBER. TSEAC consisted of a core of 15 voting members, including a Chair. Members and the Chair were selected by the Commissioner or designee from among authorities knowledgeable in the fields of clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, and other related professions. The most recent industry representative was Douglas Lee, Ph.D., Senior Vice President, Plasma Product Development, CSL Behring.

  • National Institutes of Health (NIH)
    NIH is made up of 27 different components called Institutes and Centers. Each has its own specific research agenda, often focusing on particular diseases or body systems. All but three of these components receive their funding directly from Congress, and administrate their own budgets. NIH leadership plays an active role in shaping the agency's research planning, activities, and outlook. The Office of the Director (OD) is the central office, responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components. Headquarters for the OD and the Institutes and Centers are located in Bethesda, Maryland, USA. NIH has more than 75 buildings in a campus-like environment over 300 acres. Some research is performed on campus in state-of-the-art laboratory facilities, although more than 80 percent of research activities are conducted by scientists working in every state and around the world.

    • National Heart, Lung, and Blood Institute (NHLBI)
      NHLBI provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public.

  • U.S. Public Health Service (USPHS)
    The USPHS Commissioned Corps is a uniformed service of more than 6,000 health professionals who serve in many federal agencies throughout HHS, including CDC, FDA, and NIH. The Surgeon General is head of the Commissioned Corps. As one of the seven U.S. uniformed services, the Commissioned Corps fills essential public health leadership and service roles within Federal government agencies and programs.

  • U.S. Pharmacopeial Convention (USP)
    USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the U.S. by FDA, and these standards are used in more than 140 countries. Since its founding in 1820, USP has helped secure the quality of the American drug supply. Building on that legacy, USP today works with scientists, practitioners, and regulators of many nations to develop and revise standards that help protect public health worldwide.

Rest of World

  • Brazilian Health Surveillance Agency (Anvisa)
    Anvisa was created by Law 9782, enacted in 1999. It is a governmental regulatory agency characterized by its administrative independence, financial autonomy, and the stability of its directors. Anvisa is ruled by a Collegiate Board of Directors composed of five members. In the federal public administrative structure, Anvisa is connected to the Ministry of Health, with whom a periodic management contract is signed. Anvisa’s primary goal is to protect and promote public health, by exercising health surveillance over products and services, including processes, ingredients and technologies that pose any health risks. Anvisa is also responsible for health control in ports, airports and borders, as well as for establishing relations with the Ministry of International Affairs and with foreign organisms and institutions to deal with international affairs regarding health surveillance.

  • Federal Commission for the Protection against Sanitary Risk (COFEPRIS) – Mexico
    COFEPRIS is a decentralized organ of the Department of Health with technical, administrative and operational autonomy, whose mission is to protect the population against sanitary risks, through sanitary regulation, control and promotion under a single command, which provides unity and homogeneity to the policies which are determined.At COFEPRIS, the scope previously attributed to sanitary regulation, control and promotion was enlarged and transformed from an instrumental policy into a public policy objective; that is, it went from being a medium to becoming the social purpose of the latter, including other non-regulative instruments, with the intention of preserving more efficiently the population's health. COFEPRIS’s scope of competence includes sanitary regulation and promotion of the production, commercialization, import, export, publicity of, or involuntary exposure to health-related drugs and technologies, e.g. drugs, medical equipment and devices, blood and hemoderivatives, organ transplant, and health services.

Global

  • World Health Organization/Expert Committee on Biological Standardization (WHO/ECBS)
    As the authority responsible for directing and coordinating authority for health within the United Nations system, WHO is providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring, and assessing health trends. WHO has commissioned ECBS to establish International Biological Reference Preparations and Recommendations and Guidelines for the manufacturing, licensing, and control of blood products, cell regulators, vaccines, and related in vitro diagnostic tests. Acting as individual experts and, not representatives of organizations or employers, ECBS members are scientists from national control agencies, academia, research institutes, public health bodies, and the pharmaceutical industry, whose decisions and recommendations are based entirely on scientific principles and considerations of public health do not necessarily reflect the decisions or the stated policy of WHO. The ECBS has met on an annual basis since 1947 and reports to the WHO Executive Board, the executive arm of the World Health Assembly. The PPTA Vice President, Global Regulatory Policy, serves on the ECBS.

    To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publications and encourages their translation and adaptation. The WHO Technical Report Series (TRS) is published annually and makes available the findings of various international groups of experts that provide WHO ECBS with the latest scientific and technical advice on a broad range of medical and public health subjects.

    The most recent report from ECBS October 2015 meeting can be found here.