Dr Pramod Kumar Pandey BSc (Hons), MSc, PhD, founder of PharmaGuru.co, is a highly experienced Analytical Research Expert with over 31 years in the pharmaceutical industry. He has played a key role in advancing innovation across leading Indian and global pharmaceutical companies. He can be reached at admin@pharmaguru.co
Major Pharmaceutical Regulatory Agencies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), India’s Central Drugs Standard Control Organisation (CDSCO), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). These national and international bodies are responsible for ensuring the safety, efficacy, and quality […]
Pharmaceutical Regulatory Agencies and Their Key Functions: Get Mastery With 9+ FAQs
Major Pharmaceutical Regulatory Agencies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), India’s Central Drugs Standard Control Organisation (CDSCO), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). These national and international bodies are responsible for ensuring the safety, efficacy, and quality of medicines through stringent regulations, product approvals, and ongoing post-market surveillance to safeguard public health.
Let’s take a tour around the world to meet some of these key agencies and learn what they do.
Pharmaceutical Regulatory Agencies: FAQS
What are regulatory agencies in pharma?
Regulatory agencies in pharma are government bodies that ensure medicines are safe, effective, and high-quality before and after they reach the market.
What is CDSCO in pharma?
CDSCO (Central Drugs Standard Control Organization) is India’s national regulatory authority for drugs and medical devices. It oversees drug approval, clinical trials, and safety monitoring.
What is 21 CFR in pharma?
21 CFR refers to Title 21 of the Code of Federal Regulations in the USA, which contains rules set by the FDA for food, drugs, and medical devices.
What is FDA called in India?
India does not have an “FDA”; the equivalent regulatory authority is CDSCO under the Ministry of Health and Family Welfare.
What is the full form of ICSR?
ICSR stands for Individual Case Safety Report, which is a detailed report of an adverse event or side effect experienced by a patient after using a drug.
What is the full form of ICH?
ICH stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
What are the key functions of regulatory agencies?
1. Approve new drugs and vaccines 2. Ensure product safety and quality 3. Monitor side effects (pharmacovigilance) 4. Inspect manufacturing sites 5. Enforce drug laws and regulations
What is the difference between FDA and CDSCO?
Both are drug regulatory bodies, but the FDA operates in the United States, while CDSCO functions in India. Each follows its own regulatory framework, but their goals are similar: to protect public health.
What is 21 CFR and why is it important?
21 CFR is Title 21 of the U.S. Code of Federal Regulations. It contains the FDA’s rules for drugs, biologics, and medical devices, including manufacturing practices (GMP), labeling, and electronic records.
Coordinates scientific evaluation of medicines across EU member states.
Provides centralized drug approval for the entire EU.
Oversees pharmacovigilance through the EudraVigilance system.
Supports innovation and access to new medicines.
Ensures transparency and public trust in drug evaluation processes.
3. MHRA – Medicines and Healthcare products Regulatory Agency
Where: United Kingdom What it does:
Approves new medicines and vaccines in the UK.
Monitors medicines already in use for safety.
Investigates complaints or concerns about products.
Ensures high standards in clinical trials and manufacturing.
Since Brexit, the MHRA is fully responsible for regulating medicines in the UK, acting independently from the EU.
4. Health Canada
Where: Canada What it does:
Evaluates new drugs before they’re sold in Canada.
Monitors side effects and product recalls.
Makes sure medical products meet Canadian health and safety standards.
Works with international partners to improve public safety.
Health Canada also provides clear guidance for Canadian consumers on how to use medications safely.
5. Pharmaceuticals and Medical Devices Agency (PMDA)
Country: Japan
Key Functions:
Reviews marketing applications for drugs and medical devices.
Conducts GCP (Good Clinical Practice) and GMP inspections.
Collaborates with the Japanese Ministry of Health, Labour and Welfare (MHLW).
Engages in risk management and safety monitoring.
Offers guidance to pharmaceutical companies during development stages
6. Central Drugs Standard Control Organization (CDSCO)
Country: India
Key Functions:
Monitors adverse drug reactions through PvPI (Pharmacovigilance Programme of India).SCO’s role is key for global supply chains.
Approves new drugs and clinical trials in India.
Regulates import and manufacture of pharmaceuticals.
Oversees drug labeling and standards of quality.
Coordinates with state-level drug regulatory authorities.
7. National Medical Products Administration (NMPA)
Country: China
Key Functions:
Formerly known as CFDA (China Food and Drug Administration).
Evaluates and approves pharmaceuticals, vaccines, and devices.
Ensures compliance with manufacturing standards.
Manages post-market surveillance and recalls.
Plays a growing role in international regulatory harmonization
8. World Health Organisation (WHO) – Prequalification Programme
Scope: Global
Key Functions:
Assesses medicines, vaccines, diagnostics, and medical devices for quality, safety, and efficacy.
Provides a list of prequalified products for procurement by international agencies (e.g., UNICEF).
Assists regulatory capacity building in low- and middle-income countries.
Promotes global health security and equitable access to medicines.
Why Pharmaceutical Regulatory Agencies Matter?
These agencies don’t just enforce rules — they shape the entire lifecycle of a drug, from development and trials to approval and monitoring. Their key contributions include:
Protecting public health from substandard or unsafe products.
Encouraging innovation by setting clear regulatory pathways.
Building trust among healthcare providers and patients.
Facilitating global trade and harmonisation in pharmaceuticals.
Conclusion
Regulatory agencies around the world make it possible for us to trust the medicines we take. While each country has its own system, they often work together to raise global standards and protect public health.
So the next time you take a simple tablet or get a vaccine, remember — a lot of care, science, and strict rules are behind that little bottle. And that’s a good thing.
