History of Pharmaceutical Regulatory Agencies

Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public, to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.


Abstract__ Medicine has existed since the dawn of human civilization. Diseases were originally thought to be caused by deities or supernatural forces. Various ancient civilizations, from the Egyptians to the Chinese, developed their own unique systems for practicing medicine in the fields of herbalism, anatomy, public health, and clinical diagnostics. And by time the Herbal treatment became a cultural heritage among people. Later, the Herbal usage was developed by using chemistry in producing herbal extracts or/and combined compounds which leads to health hazards to the patients; So, the initiation for the Pharmaceutical Regulatory Agencies (PRA) were a must to provide margins of controls and safety for this new industry.

the Arab Guide to Herbal Medicine, de Materia Medica of Descurides.1334

the Arab Guide to Herbal Medicine, de Materia Medica of Descurides.1334

I. Introduction:

Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public, to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.  They also play a vital role to ensure and increase regulatory implementation in non-regulated parts of the world for safety of people residing there. The international regulatory organizations play essential role inall aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.

This paper aims to introduce the main Pharmaceutical regulatory agencies that their rules are followed by large number of organizations and countries as a guidance in the pharmaceutical industry; we shall highlight these agencies, their origin, purposes and activities whether they are Governmental or Non-governmental agencies.

II. Types of Regulatory agencies

A. Governmental agencies;

These agents are considered as an official and a representative agencies or sectors of a government, where its regulations and requirements are obligatory fulfilled by the pharmaceutical organizations under its scope of control and supervision rather than that these agencies have the authority to approve and regulate the activities for the pharmaceutical bodies for example the ministry of health in a country is considered as a regulatory agency for the pharmaceutical industry and medicine trading in this country which should be followed and applied.

First; Food and Drug Administration (FDA)

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The most famous governmental PRA is FDA in the U. S. federal government.

FDA is the oldest comprehensive consumer protection agency in the U. S. federal government.), which originated in 1902 by an act of U.S. Congress, regulates the modern pharmaceutical industry. (The agency is also a scientific and public health agency with oversight for the safety of most food products, radiation-emitting consumer products, cosmetics, and animal feed its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace. In 1938 a stronger law and gave the FDA injunctive power, put cosmetics under regulation for the first time and gave the agency authority to set food standards after 100 people died after taking a new wonder drug.

What does FDA regulate?

The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list. In general, FDA regulates:

Foods, including:

  • dietary supplements, food additives.
  • bottled water
  • infant formulas

Drugs, including:

  • prescription drugs (both brand-name and generic)
  • non-prescription (over-the-counter) drugs

Biologics, including:

  • vaccines and allergenics
  • blood and blood products
  • cellular and gene therapy products
  • tissue and tissue products

In addition to; Medical Devices, Cosmetics, Veterinary Products, Electronic Products that give off radiation, and Tobacco Products.

The FDA regulations is announced under the term of codes of Federal regulations (CFR), CFR 21 – title Food and Drugs regulations is the handling all the FDA requirements for pharmaceutical and drug industry.

Second; European Medicines Agency (EMA)

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it is founded in 1995.EMAhas worked across the European Union (EU) and globally to protect public and animal health by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based information on medicines. EMA was set up to harmonize the work of the already existing national medicine regulatory bodies in Europe.
 
EMA’s success is based on the cooperation within the European Union Drug Regulatory Authorities where a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. 

Working together has encouraged the exchange of knowledge, ideas and best practices, to ensure the highest standards in medicines regulation. European Union Drug Regulatory Authorities; which is published as EudraLex which the collection of rules and regulations is governing medicinal products in the European Union.

EudraLex consists of 10 volumes, 6 directives, 19 Annexes and a set of Miscellaneous supportive documents.

Document history for EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use;

Document History

 

Th first edition of the Guide was published, including an annex on the manufacture of sterile medicinal products.

1989

The second edition was published; implementing Commission Directive 91/356 of 13 June 1991 and 91/412 of 23 July 1991 laying down the principles and guidelines on good manufacturing practive for medicinal products for human use as well as for veterinary medicinal products. The second edition also included 12 additional annexes.

January 1992

An update of legal references was made. In the meantime, the guide is updated as needed on the website of the European Commission, several additional annexes added.

August 2004

 

Re-structuring of GMP guide, consisting of Part I for medicinal products for human and veterinary use and Part II for active substances used as starting materials, implementing Directives 2004/27/EC and 2004/28/EC. The current guide includes 17 Annexes, the former Annex 18 being replaced.

October 2005

Update of the text and introduction of a new part III.

December 2010

EU Commission Brussels, SANCO/C8/AM/sl/ares(2010)1064597

Third: The Medicines and Healthcare Products Regulatory Agency (MHRA)

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The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory center within the group.

MHRA's advisory bodies have created a number of independent advisory committees to provide impartial advice to ministers about the regulation of medicines and medical devices. These committees may also establish working groups to address specific problems. Members of these committees may receive a fee and claim some expenses.

B. Non-Governmental agencies;

These agencies are mainly independent, non-governmental organizations that work through a committee of people who are involved in the pharmaceutical industries as there provide the guidance which to be followed to provide a degree of confidence for product quality and by time these agencies guidelines became obligatory in many countries.

First; World Health Organization (WHO);

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WHO is a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948 headquartered in Geneva, Switzerland. The WHO is a member of the United Nations Development Group. Its predecessor, the Health Organization, was an agency of the League of Nations.

WHO is adopted many programs related to health for all people aimed to improve and provide healthier future for people all over the world.

Working through offices in more than 150 countries, WHO staff work side by side with governments and other partners to ensure the highest attainable level of health for all people.The regulations are announced under the term of Essential medicines and health products is the handling all the requirements for pharmaceutical and drug industry.

The guidelines developed by WHO are prepared through a vast global consultative process involving WHO Member States, national authorities and international agencies; in consultation with the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, with specialists from industry, national institutions, nongovernmental organizations, etc.

The draft WHO guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, adopted as international standards.WHO Standards are announced as a set of annexes and Technical Report Series.

Second; International Conference on Harmonization (ICH)

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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and

application of technical guidelines and requirements for product registration. ICH guidelines have been adopted as law in several countries but are only used as guidance for FDA.

The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.

ICH Guidelines topics are divided into four categories and ICH topic codes are assigned according to these categories Quality guideline, efficacy guideline, Safety guideline and multidisciplinary guidelines.

  1. Quality guideline: Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
  2. Efficacy guideline: The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived frombiotechnological processes and the use pharmacogenetics/genomics techniques to produce better targeted medicines.
  3. Safety guideline: ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
  4. Multidisciplinary guidelines Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA),
  5. The Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

The ICH Harmonized Tripartite Guideline moves immediately to the final step of the process that is the regulatory implementation. This step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements, in the European Union, Japan, and the United States.

Third: The Pharmaceutical Inspection Co-operation Scheme (PIC/S).

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PIC/S was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970.

The initial members of PIC comprised the 10-member countries of EFTA at that time, ie. Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland and United Kingdom. Membership of PIC was subsequently expanded to include Hungary, Ireland, Romania, Germany, Italy, Belgium, France and Australia.

It was realised in the early 1990s that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC.

Australia was the last country that was able to become a member of PIC in January 1993. Consequently, the PIC Scheme was formed on 2 November 1995. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S.

The original goals of PIC were: Mutual recognition of inspection,Harmonization of GMP requirements, Uniform inspection systems, Training of inspectors, Exchange of information and Mutual confidence PIC/S guidance consists of 4 main parts as illustrated below;

GMP

Reference

PIC/S GMP GIUDE (INTRODUCTION)

PE 009-13 (Intro)

PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS)

PE 009-13 (Part I)

 

PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS)

PE 009-13 (Part II)

PIC/S GMP GUIDE (RELATED ANNEXES)

PE 009-13 (Annexes)

PIC/S GMP guide

III. Conclusion

Regulatory agencies and organizations around the worldneed to ensure the safety, quality and efficacy of medicines and medical devices, harmonization of legal procedures related to drug development, monitoringand ensuring compliance with statutory obligations. However the need of the hour is

  • More centralized procedures in drug regulation
  • Harmonization of regulatory norms
  • Strengthening the regulatory authorities

List of Most Common Regulatory Authority in the worls

Country

Name of Regulatory Authority

USA

 Food and Drug Administration (FDA)

UK

Medicines and Healthcare Products Regulatory Agency (MHRA)

Australia

 Therapeutic Goods Administration (TGA)

India

 Central Drug Standard Control Organization (CDSCO)

Canada

 Health Canada

Europe

European Medicines Agency (EMEA)

EGYPT

Ministry of Health (MOH)

Denmark

Danish Medicines Agency

Costa Rica

Ministry of Health

New Zealand

Medsafe - Medicines and Medical Devices Safety Authority

Sweden

Medical Products Agency (MPA)

Netherlands

Medicines Evaluation Board

Ireland

Irish Medicines Board

Italy

 Italian Pharmaceutical Agency

Nigeria

 National Agency for Food and Drug Administration and Control (NAFDAC)

Ukraine

 Ministry of Health

Singapore

Centre for Pharmaceutical Administration Health Sciences Authority

Hong Kong

Department of Health: Pharmaceutical Services

Paraguay

Ministry of Health

Sweden

Medical Products Agency (MPA)

Thailand

 Ministry of Public Health

China

State Food and Drug Administration

Germany

Federal Institute for Drugs and  Medical Devices

Malaysia

National Pharmaceutical Control Bureau,Ministry of Health

Pakistan

Drugs Control Organization, Ministry of Health

South Africa

Medicines Control Council

Sri Lanka

SPC,Ministry of Health

Switzerland

Swissmedic  , Swiss Agency for Therapeutic Products

Uganda

Uganda National Council for Science and Technology (UNCST)

Brazil

Agencia Nacional de Vigiloncia Sanitaria (ANVISA )

Japan

Ministry of Health, Labour & Welfare(MHLW)

INTERNATIONAL ORGANIZATIONS

World Health Organization (WHO)

Pan American Health Organization (PAHO)

World Trade Organization (WTO)

International Conference on Harmonization (ICH)

World Intellectual Property Organization (WIPO)

I.V. References

  1. Essential Medicines and Health Products Information Portal A World Health Organization resource http://apps.who.int/medicinedocs/en/d/Js4875e/
  2. Http://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf
  3. Http://www.who.int/medicines/publications/essentialmedicines/en/
  4. European Medicines Agency (EMA); https://europa.eu/european-union/about-eu/agencies/ema_en
  5. European commission health and consumers directorate GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064597 eudralex The Rules Governing Medicinal Products in the European Union https://www.agilent.com/cs/library/slidepresentation/public/EUGMP_Volume4_Chapters_1_9.pdf
  6. Eudralex - EU Legislation https://ec.europa.eu/health/documents/eudralex_en
  7. Milestones in U.S. Food and Drug Law History https://www.fda.gov/aboutfda/whatwedo/History/forgshistory/evolvingpowers/ucm2007256.htm
  8. A History of the FDA and Drug Regulation in the United States https://www.fda.gov/downloads/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/ucm093550.pdf
  9. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Usehttps://en.wikipedia.org/wiki/International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
  10. Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development; https://www.pharmatutor.org/articles/pharmaceutical-regulatory-agencies-and-organizations-around-world-scope-challenges-in-drug-development

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