Worldwide Pharmaceutical and Healthcare Products Regulatory Agencies and Their Functions

What are drug regulatory agencies? | What is the role of the drug regulatory authority? | Pharmaceutical Regulatory Agency | Drug Regulatory Agency | Medicines Regulatory Agency

Introduction

Pharmaceuticals are considered as the one of the most highly regulated industries worldwide. The regulatory agencies ensure compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for development, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products, blood products, food and cosmetics.

Medicinal products regulatory authority and organizations are responsible for effective drug regulation. This is 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 in pharmaceutical industry aim at the protection of human health.

What is the Role of the Drug Regulatory Authority ? 

Effective Regulation of Pharmaceuticals Drug Products Requires a Variety of Functions by Drug Regulatory Authority:

For Example:

• Ensuring the efficacy, safety and quality of medicinal products and devices
• Licensing of premises, persons and practices
• Inspection of manufacturing plants
• Product assessment and registration
• Adverse drug reaction monitoring
• Quality control
• Control of drug promotion and advertising

The drug regulation consists of: 

• Drug laws

• Drug Regulatory Agencies

• Drug Regulatory Boards

• Quality Control

• Drug Information Centres.

List of Worldwide Drug Regulatory Agencies

Country	Regulatory Agency
Australia	Therapeutic Goods Administration (TGA)
Brazil	Agência Nacional de Vigilância Sanitária (ANVISA)
Canada	Health Canada
China	National Medical Products Administration (NMPA)
Denmark	Danish Medicines Agency
Europe	European Medicines Agency (EMA)
Germany	Federal Institute for Drugs and  Medical Devices
Hong Kong	Department of Health: Pharmaceutical Services
India	Central Drugs Standard Control Organisation (CDSCO)
Ireland	Irish Medicines Board
Italy	Italian Pharmaceutical Agency
Japan	Pharmaceuticals and Medical Devices Agency (PMDA)
Korea	Korea Food and Drug Administration (KFDA)
Malaysia	National Pharmaceutical Regulatory Agency (NPRA)
Netherlands	Medicines Evaluation Board
New Zealand	Medsafe - Medicines and Medical Devices Safety Authority
Nigeria	National Agency for Food and Drug Administration and Control (NAFDAC)
Pakistan	Drugs Control Organization, Ministry of Health
Philippines	Food and Drug Administration of the Philippines
Singapore	Health Sciences Authority (HSA)
South Africa	South African Health Products Regulatory Authority (SAHPRA)
Sri Lanka	Ministry of Health (MoH)
Sweden	Medical Products Agency (MPA)
Switzerland	Swissmedic, Swiss Agency for Therapeutic Products
Thailand	Food and Drug Administration, Thailand
Uganda	Uganda National Council for Science and Technology (UNCST)
United Kingdom	Medicines and Healthcare Products Regulatory Agency (MHRA)
US	United States Food and Drug Administration (US FDA)
Ukraine	Ministry of Health
Zimbabwe	Medicines Control Authority of Zimbabwe (MCAZ)

International Regulatory Agencies and Organizations

• World Health Organization (WHO)

• International Conference on Harmonization (ICH)

• Pan American Health Organization (PAHO)

• World Trade Organization (WTO)

• World Intellectual Property Organization (WIPO)

These International Regulatory Agencies and Organizations also play significant role in applying pharmaceutical regulations in all aspects related to drug research and development, registration, manufacturing, distribution, marketing and price control.

Major Challenges of Regulatory Bodies 

Pharmaceuticals Regulatory Agencies face many challenges those are:  

·        to promote public health and protect the public from unsafe drugs.

·  to institute legalization covering all products with a medicinal claim and all relevant pharmaceutical activities, whether carried out by the public or the private sector.

·        to enhance worldwide regulatory development to ensure safety of people.

Common Terminology Used by Various Drugs Regulatory Agencies  

Clinical Investigation

US: IND - Investigational New Drug (Application)

EU: CTA / CTX - Clinical Trial Authorization/Clinical Trials Exemption

Marketing Approval

US:

NDA - New Drug Application,  

ANDA - Abbreviated New Drug Application,

BLA - Biologic License Application

EU: 

EEA: European Economic Area

EC: European Commission

MAA – Marketing Authorization Application

CP: Centralised Procedure

DCP: Decentralised Procedure

MRP: Mutual Recognition Procedure

RMS: Reference Member State

PRAC: Pharmacovigilance Risk Assessment Committee

ICH:

ICH - International Council for Harmonisation

CTD - Common Technical Document, Common format for marketing authorization (registration)

Labelling

US: Primary and Secondary Container, Prescribing Information/Package Insert (PI), Patient Package Insert (PPI), Structured Product Labeling (SPL)

EU:

SPC: Summary of Product Characteristics

PIL: Patient Information Leaflet

EPAR: European Public Assessment Report 

   

Summary  

Drug regulatory agencies and organizations around the world are responsible for the safety, quality and efficacy of medicines and medical devices, harmonization of legal procedures related to drug development, approval and post-marketing monitoring and ensuring compliance with statutory obligations.