SIGNIFICANCE OF PHARMACEUTICAL REGULATORY BODIES - A REVIEW

 

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ABOUT AUTHORS
G. TARUN KUMAR REDDY *1, G. NAVEEN KUMAR REDDY 2
1 Department of Pharmaceutics and Drug regulatory affairs,
Annamacharya college of Pharmacy,
Rajampet, Kadapa, Andhra Pradesh, India.
2 Department of Pharmaceutical analysis,
Sri Padmavathi school of Pharmacy,
Chittoor, Andhra Pradesh, India.

*gtarunkreddy@gmail.com

ABSTRACT: 
The regulatory bodies are being established in various pharmaceutical industries across the globe which plays a vital role to meet the requirements of legal procedures related to drug development process in a country. The pharmaceutical industry is considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Countries possess their own regulatory authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of pharmaceutical products. In an ever-changing regulatory environment, the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug. This article describes about the development of the drugs as it is a cumbersome process which includes several months of time, volunteers, and a huge finical investment majorly through the funding process, so it is strictly regulated as per the norms and regulations as given by those individual countries to carry out the drug development which were generally governed by the Drug Regulatory Affairs Personals.

REFERENCE ID: PHARMATUTOR-ART-2514

PharmaTutor (Print-ISSN: 2394 - 6679; e-ISSN: 2347 - 7881)

Volume 5, Issue 8

Received On: 24/04/2017; Accepted On: 02/05/2017; Published On: 01/08/2017

How to cite this article: Reddy GTK, Reddy GNK;Significance of Pharmaceutical Regulatory Bodies - A Review; PharmaTutor; 2017; 5(8); 15-22

INTRODUCTION
All substances are poisonous beyond a certain dose. The right dose differentiates whether the substance is poison or remedy. As per Paracelsus no drug product is completely safe or efficacious in all circumstances, but there is a moral as well as legal, expectation that appropriate steps are taken to assure optimal quality, safety and efficacy by the producers concerned. (1) Regulatory affairs serve as a roadmap for prescription drugs, biologics and medical device development. Regulatory affairs focus on harmonization with international regulations, new drug applications, good manufacturing practice, quality system compliance, documentation requirements and facilitate an understanding of compliance and product approval, including clinical trial exemptions, fast track status and advisory committee procedures. (2)

Regulatory authority and organizations are responsible in effective drug regulation required to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public. Regulatory bodies provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. Every country has its own regulatory agencies which are holding the all the regulatory matters of that country relating to the drug substances.

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 (2)

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 in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research, development and intellectual property protection.

The regulatory authorities have a particular need to communicate when incidents occur or when issues are raised, but the communication in these ‘crisis' situations is likely to be much more effective if a relationship has already been established through regular routine communications. Hence proactive communication about safety and regulation when there are no incidents to report can be just as important as communication in response to events.(3)

The major changes in Indian regulatory environment on clinical trials for import and manufacture of new drug were introduced in the Drug and Cosmetics Rules as Schedule Y in 1998. Ethical Guidelines for Biomedical Research on Human subjects was brought by Indian Council of Medical Research (ICMR) in 2000. Good Clinical Practices were adopted by India in 2001 by Central Drugs Standard Control Organization (CDSCO). The National Institute of Medical Statistics of ICMR also commenced the clinical trials registry in 2009. (4)

 

Historical background of Regulatory Affairs
In 1950’s, multiple tragedies such as the sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of the legislations for drug products quality, safety and efficacy. This has also resulted into stricter norms for marketing authorization and good manufacturing practices. In 1937 due to diethylene glycol poisoning, 100 people died and in 1956 a thalidomide disaster which majorly triggered for the development of the modern regulatory controls on the drug development and supply. (7) Hence to ensure the quality, safety and efficacy of drug products and in order to assure the continued protection of public health the regulatory agencies were introduced in the late 1950’s.

Objectives:-
The main objectives of the regulatory affairs are as given below:-
* Regulatory Affairs specialists coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations. They may also compile and prepare materials for submission to regulatory agencies.
* The regulatory bodies play a vital role in between the companies and the government agencies.
* Regulatory affairs department plays a vital role to ensure the safety and efficacy of the drugs available to the public in the market.
* Regulatory bodies set guidelines for the manufacturing, importation, distribution of drugs and also monitors adverse drug reactions (ADR’s).
* Regulatory affairs help in the legalization covering all products with a medicinal claim and all relevant pharmaceutical activities, whether carried out by the public or the private sector.

The need of regulatory affairs
Drug development and commercialization is a highly regulated path to drug registration marketing is paved with good intention but can be complicated as things change constantly. Regulatory bodies deal in the areas of administrative law, regulatory law, secondary legislation, and rule making (codifying and enforcing rules and regulations and imposing supervision or oversight for the benefit of the public at large). The existence of independent regulatory agencies is justified by the complexity of certain regulatory and supervisory tasks that require expertise, the need for rapid implementation of public authority in certain sectors, and the drawbacks of political interference. Some independent regulatory agencies perform investigations or audits, and other may fine the relevant parties and order certain measures. (7)

Fig No: 1 Role of regulatory affairs in drug development

Mission of regulating bodies
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats. (8)

Regional Regulatory Bodies

 

S.No.

 

 

COUNTRIES

 

REGULATING BODIES

  1.  

Australia

 

Therapeutic Goods Administration (TGA)

  1.  

Brazil

 

Agencia Nacional de Vigiloncia Sanitaria (ANVISA )

National Health Surveillance Agency

  1.  

Canada

Health Canada

  1.  

China

State  Food and Drug Administration

  1.  

Denmark

Danish Medicines Agency

  1.  

Europe

European Medicines Agency (EMEA)

  1.  

India

 

Central Drug Standard Control Organization (CDSCO)

  1.  

Italy

Italian Medicines Agency (AIFA)

  1.  

Ireland

Irish Medicines Board

  1.  

Japan

Ministry of Health, Labour and Welfare (MHLW)

  1.  

Malaysia

National Pharmaceutical Control Bureau

  1.  

New Zealand

 

Med safe - Medicines and Medical Devices Safety Authority

  1.  

Netherlands

Medicines Evaluation Board

  1.  

Nigeria

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

  1.  

Singapore

Centre for Pharmaceutical Administration Health Sciences Authority

  1.  

South Africa

Medicines Control Council (MCC)

  1.  

Switzerland

 

Swissmedic  , Swiss Agency for Therapeutic Products

  1.  

Thailand

Thailand Food and Drug Administration

  1.  

USA

Food and Drug Administration (FDA)

  1.  

United Kingdom

 

Medicines and Healthcare Products Regulatory Agency (MHRA)

  1.  

Germany

Federal Institute of health and Medical Devices

  1.  

 

 

  1.  

Sri Lanka

 

Cosmetics, Devices & Drugs regulatory authority of Sir Lanka

  1.  

Uganda

 

Uganda National Council for Science and Technology (UNCST)

  1.  

Ukraine

Ministry of Health

Table: 1 Regional Regulating Bodies (7).

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