RegulatoryGlossary Term
ICH E6(R3) Section 1.49
A body with the power to regulate clinical trials and approve medicinal products for marketing within its jurisdiction.
Regulatory authorities are governmental bodies empowered to oversee clinical research and approve drugs, biological products, and medical devices for commercial distribution within their respective jurisdictions. These agencies establish and enforce the rules governing clinical trials, review applications for marketing authorization, and conduct inspections to verify compliance with applicable requirements. Their decisions determine whether new therapies can be made available to patients in their countries.
Major regulatory authorities whose requirements significantly influence global drug development include the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada. Each authority has its own specific requirements, though international harmonization efforts through ICH have aligned many technical standards. Sponsors conducting multinational trials must ensure compliance with the requirements of each authority in countries where they intend to seek marketing approval.
Interactions with regulatory authorities occur throughout the drug development lifecycle. Before initiating clinical trials, sponsors typically submit investigational applications providing preclinical data supporting the proposed human studies. During trials, sponsors submit safety reports and may request guidance through formal meetings. Following trial completion, comprehensive marketing applications present the complete evidence package supporting approval. Post-approval, sponsors must fulfill ongoing reporting requirements and may be subject to inspections verifying continued compliance.
Pre-submission meeting
"The sponsor requested a pre-submission meeting with the FDA to discuss the Phase III development plan and obtain guidance on the endpoints and statistical approach for the pivotal trials."
International submission
"Following completion of the global Phase III program, the sponsor submitted marketing applications simultaneously to the FDA, EMA, and PMDA to seek approval in the three major ICH regions."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.
ICH E6(R3) Section 1.49
A body with the power to regulate clinical trials and approve medicinal products for marketing within its jurisdiction.
Regulatory authorities are governmental bodies empowered to oversee clinical research and approve drugs, biological products, and medical devices for commercial distribution within their respective jurisdictions. These agencies establish and enforce the rules governing clinical trials, review applications for marketing authorization, and conduct inspections to verify compliance with applicable requirements. Their decisions determine whether new therapies can be made available to patients in their countries.
Major regulatory authorities whose requirements significantly influence global drug development include the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada. Each authority has its own specific requirements, though international harmonization efforts through ICH have aligned many technical standards. Sponsors conducting multinational trials must ensure compliance with the requirements of each authority in countries where they intend to seek marketing approval.
Interactions with regulatory authorities occur throughout the drug development lifecycle. Before initiating clinical trials, sponsors typically submit investigational applications providing preclinical data supporting the proposed human studies. During trials, sponsors submit safety reports and may request guidance through formal meetings. Following trial completion, comprehensive marketing applications present the complete evidence package supporting approval. Post-approval, sponsors must fulfill ongoing reporting requirements and may be subject to inspections verifying continued compliance.
Pre-submission meeting
"The sponsor requested a pre-submission meeting with the FDA to discuss the Phase III development plan and obtain guidance on the endpoints and statistical approach for the pivotal trials."
International submission
"Following completion of the global Phase III program, the sponsor submitted marketing applications simultaneously to the FDA, EMA, and PMDA to seek approval in the three major ICH regions."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.