RegulatoryGlossary Term
ICH E6(R3) Section 1.29
An official review of documents, facilities, records, and other resources by regulatory authorities to assess compliance with applicable regulations, standards, and guidelines.
A regulatory inspection represents an official examination conducted by government authorities to verify compliance with laws, regulations, and standards governing clinical research. Unlike sponsor-conducted audits, inspections carry regulatory authority and may result in official findings that affect drug approvals, require mandatory corrective actions, or lead to enforcement proceedings. Regulatory agencies including the FDA, EMA, and national authorities worldwide have the power to conduct inspections at any time.
Inspections may be routine, scheduled as part of normal regulatory oversight, or may be triggered by specific concerns such as unusual data patterns, complaints, or safety signals. Pre-approval inspections typically occur before regulatory approval decisions and focus on verifying that submitted data accurately represents trial conduct. Post-approval inspections monitor ongoing compliance and may focus on marketed product trials or expanded access programs. For-cause inspections are initiated in response to specific concerns about potential non-compliance.
Preparation for inspections is an ongoing process, not a last-minute activity. Sites and sponsors must maintain complete, accurate, and accessible documentation throughout the trial to ensure readiness for inspection at any time. When an inspection is announced, the inspected party should ensure that key personnel are available, that requested documents can be provided promptly, and that appropriate workspace is available for inspectors. Following the inspection, official findings must be addressed through formal responses that describe corrective and preventive actions taken.
Pre-approval inspection
"The FDA notified the sponsor that it would conduct a pre-approval inspection of the principal investigator's site to verify the pivotal Phase III efficacy data prior to making an approval decision."
Inspection finding
"The EMA inspector issued a critical finding regarding inadequate documentation of the informed consent process at one site, requiring immediate corrective action and impact assessment on data integrity."
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 1.29
An official review of documents, facilities, records, and other resources by regulatory authorities to assess compliance with applicable regulations, standards, and guidelines.
A regulatory inspection represents an official examination conducted by government authorities to verify compliance with laws, regulations, and standards governing clinical research. Unlike sponsor-conducted audits, inspections carry regulatory authority and may result in official findings that affect drug approvals, require mandatory corrective actions, or lead to enforcement proceedings. Regulatory agencies including the FDA, EMA, and national authorities worldwide have the power to conduct inspections at any time.
Inspections may be routine, scheduled as part of normal regulatory oversight, or may be triggered by specific concerns such as unusual data patterns, complaints, or safety signals. Pre-approval inspections typically occur before regulatory approval decisions and focus on verifying that submitted data accurately represents trial conduct. Post-approval inspections monitor ongoing compliance and may focus on marketed product trials or expanded access programs. For-cause inspections are initiated in response to specific concerns about potential non-compliance.
Preparation for inspections is an ongoing process, not a last-minute activity. Sites and sponsors must maintain complete, accurate, and accessible documentation throughout the trial to ensure readiness for inspection at any time. When an inspection is announced, the inspected party should ensure that key personnel are available, that requested documents can be provided promptly, and that appropriate workspace is available for inspectors. Following the inspection, official findings must be addressed through formal responses that describe corrective and preventive actions taken.
Pre-approval inspection
"The FDA notified the sponsor that it would conduct a pre-approval inspection of the principal investigator's site to verify the pivotal Phase III efficacy data prior to making an approval decision."
Inspection finding
"The EMA inspector issued a critical finding regarding inadequate documentation of the informed consent process at one site, requiring immediate corrective action and impact assessment on data integrity."
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.