Clinical Research Regulatory Bodies

Clinical research regulatory bodies and related international organisations help ensure that clinical trials are conducted according to applicable scientific, ethical, safety and quality requirements. Their responsibilities may include authorising clinical trials, reviewing investigational products, monitoring safety, conducting inspections and establishing regulatory standards.

Regulatory responsibilities differ between countries and regions. Some organisations directly regulate or authorise clinical research, while others provide scientific assessment, regulatory coordination, technical standards or international guidance.

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) regulates clinical investigations involving drugs, biologics and medical devices that fall within its jurisdiction in the United States.

For investigational drugs and biological products, FDA reviews Investigational New Drug (IND) applications and monitors clinical development to help ensure that participants are not exposed to unreasonable risks.

For certain investigational medical devices, FDA requirements may include an Investigational Device Exemption (IDE).

FDA also establishes requirements concerning areas such as informed consent, Institutional Review Boards (IRBs), sponsor and investigator responsibilities, safety reporting, records and regulatory inspections.

European Union and European Medicines Agency (EMA)

Clinical trials of medicinal products in the European Union and European Economic Area operate under the Clinical Trials Regulation (Regulation (EU) No 536/2014).

Clinical trial applications are submitted through the Clinical Trials Information System (CTIS). National competent authorities and other relevant bodies in EU/EEA Member States assess and oversee clinical trials according to their responsibilities under the European regulatory framework.

The European Medicines Agency (EMA) maintains CTIS together with its European partners and supports coordination of clinical-trial activities. EMA also provides scientific advice, supports Good Clinical Practice activities and performs important functions relating to the evaluation and safety monitoring of medicines.

Therefore, EMA should not be viewed as the sole authority directly authorising clinical trials throughout the European Union.

Central Drugs Standard Control Organisation (CDSCO), India

The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority for drugs, clinical trials and other regulated medical products within its jurisdiction.

Clinical trials involving new drugs and investigational new drugs are primarily governed by the New Drugs and Clinical Trials Rules, 2019 (NDCTR 2019), as amended.

CDSCO processes applicable clinical-trial and investigational-new-drug applications and works within the regulatory framework involving the Central Licencing Authority, registered Ethics Committees and other relevant bodies.

The Drugs Controller General (India), commonly referred to as DCG(I), performs important regulatory functions within CDSCO.

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) performs scientific review, consultation, safety and other regulatory functions relating to pharmaceuticals and medical devices.

During clinical development, PMDA provides regulatory consultations concerning clinical-trial plans and data required for regulatory submissions. Its assessments consider scientific and ethical aspects, reliability of clinical trials and participant safety.

PMDA works within Japan’s regulatory system alongside the Ministry of Health, Labour and Welfare (MHLW). The relationship should therefore be understood as part of the broader Japanese regulatory framework rather than describing PMDA alone as the authority that simply “regulates clinical trials.”

World Health Organization (WHO)

The World Health Organization (WHO) is not a national medicines regulator. It contributes to clinical research by developing international guidance, promoting research standards and supporting initiatives intended to strengthen ethical and scientifically sound health research.

WHO also supports clinical-trial transparency and registration through international initiatives such as the International Clinical Trials Registry Platform (ICTRP).

Its role is therefore different from regulatory authorities that directly review or authorise clinical trials within individual jurisdictions.

International Council for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to develop harmonised scientific and technical guidelines for pharmaceutical development and registration.

ICH was originally established in 1990 as the International Conference on Harmonisation and was restructured in 2015 as the International Council for Harmonisation.

For more background on its history, structure and guideline-development process, see International Council for Harmonisation (ICH).

ICH develops internationally important guidelines covering Quality, Safety, Efficacy and Multidisciplinary topics.

For clinical research, the ICH Efficacy guidelines include standards addressing areas such as Good Clinical Practice, clinical-trial design, safety reporting and clinical study reports.

ICH itself does not authorise individual clinical trials. Its guidelines are implemented through participating regulatory authorities and regional or national regulatory frameworks.

Further information about its international harmonisation activities and guidelines is available from the International Council for Harmonisation (ICH).

Role of Clinical Research Regulatory Bodies

Clinical research regulatory bodies have different responsibilities depending on the jurisdiction, type of investigational product and applicable regulatory framework.

National and regional regulatory authorities may:

• Review or authorise clinical investigations
• Evaluate investigational products and supporting data
• Monitor participant safety
• Establish reporting requirements
• Conduct regulatory inspections
• Review applications for marketing authorisation or approval

Ethics Committees and Institutional Review Boards provide independent ethical review and help protect the rights, safety and well-being of research participants.

International organisations such as ICH and WHO contribute through harmonised standards, guidance, coordination and other activities rather than replacing national regulatory authorities.

Understanding these distinctions is important when planning multinational clinical research because sponsors must comply with the specific legal and regulatory requirements of each jurisdiction in which a clinical trial is conducted.

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