The premier global benchmark regulatory agency responsible for protecting public health through the safety, efficacy, and security of human drugs, biological products, and medical devices.
🏛️Regulatory Mandates & Responsibilities
Investigational New Drug (IND) & New Drug Application (NDA/BLA) approvals
The world’s largest and most comprehensive web-based registry and results database of publicly and privately supported clinical studies conducted worldwide.
🏛️Regulatory Mandates & Responsibilities
Mandatory registration of clinical study protocols worldwide
Transparent disclosure of patient eligibility criteria
Reporting of clinical primary and secondary endpoint results
Providing contact details of clinical study sites and investigators
Decentralised agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines across European Union member states.
🏛️Regulatory Mandates & Responsibilities
Centralised marketing authorisation of medicines throughout the EU
A global initiative aimed at establishing a single point of access and unambiguous identification of trials across national and international clinical trial registries.
🏛️Regulatory Mandates & Responsibilities
Aggregating primary registries worldwide (ClinicalTrials.gov, EU CTIS, jRCT, etc.)
Setting international standards for trial transparency
Combatting publication bias and selective reporting
