Regulatory Intelligence Terms (21)

21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures, setting the validation, audit-trail, access, and signature controls that make an electronic record equivalent to the paper record a predicate rule already requires.

BIMO is FDA's inspection program for the entities that generate research data, covering clinical investigators, sponsors, CROs, IRBs and nonclinical laboratories, and auditing study conduct and data integrity rather than manufacturing.

CBER is the FDA center that licenses biological products under section 351 of the Public Health Service Act, covering vaccines, blood, allergenics, human tissues, and cell and gene therapies, rather than the therapeutic proteins CDER reviews.

CDER is the FDA center that reviews human drugs, covering prescription, over-the-counter, and generic products plus most therapeutic biologics, while vaccines, blood products, and cell and gene therapies are reviewed by CBER.

CDRH is the FDA center that regulates medical devices, in vitro diagnostics, and radiation-emitting electronic products, reviewing premarket submissions such as the 510(k) and enforcing quality-system and adverse-event reporting duties after market entry.

Data integrity is the property of regulated records being complete, consistent, and accurate across their full lifecycle, from first capture through retention, so a reviewer can reconstruct an activity without relying on the people who performed it.

An EIR is FDA's full narrative record of a completed facility inspection, prepared after the investigator leaves and assigning the inspection a classification that determines FDA's next action. The Form 483 lists observations; the EIR evaluates them.

EMA is the European Union agency that scientifically evaluates medicines submitted through the centralised procedure and monitors their safety, issuing recommendations on which the European Commission bases legally binding EU-wide authorisation decisions.

FDA is the United States federal agency within the Department of Health and Human Services that authorizes drugs, biologics, and medical devices before marketing and regulates the safety and labeling of foods and cosmetics.

FDA Form 483 is the written list of inspectional observations an FDA investigator hands to facility management at the close of an inspection, recording conditions that may violate the FD&C Act without constituting a final agency determination.

GxP is the collective term for the good-practice regulations and guidelines that govern how regulated companies generate, document, and retain data across laboratory, clinical, and manufacturing activities.

Health Canada is the federal department that regulates drugs, medical devices, and other health products for the Canadian market, granting market authorization only through its own submission review rather than recognizing FDA or EMA approvals.

ICH is the global standards body where pharmaceutical regulators and industry associations jointly draft technical guidelines for drug quality, safety, and efficacy; it enacts no law itself, so guidelines apply only once a member authority adopts them.

Labeling is the entire body of written, printed, or graphic matter accompanying a regulated product, broader than the container label alone because it also captures the prescribing information, patient materials, and sponsor-disseminated promotional pieces.

MHRA is the United Kingdom's regulator of medicines, medical devices, and blood components for transfusion, granting UK authorisations through its own assessment or by recognising a named reference regulator, not through the EU centralised procedure.

PMDA is Japan's incorporated administrative agency that scientifically reviews drugs, medical devices, and cellular and tissue-based products for marketing approval, inspects the data and plants behind them, and runs post-marketing safety and relief services alongside MHLW.

Pre-Approval Inspection is an FDA facility inspection conducted while a drug marketing application is pending, testing whether the site can manufacture the product under cGMP and whether the application's data matches what the site actually did.

Substantial equivalence is the FDA finding that a device has the same intended use as a legally marketed predicate and either the same technological characteristics or different ones that raise no new questions of safety and effectiveness.

Swissmedic is the Swiss Agency for Therapeutic Products, the federal public law institution that authorises and supervises medicines and medical devices in Switzerland under the Therapeutic Products Act.

TGA is Australia's national regulator of therapeutic goods, applying the Therapeutic Goods Act 1989 to decide which medicines, biologicals and medical devices may enter the Australian Register of Therapeutic Goods and be supplied lawfully.

A Warning Letter is FDA's informal advisory correspondence notifying a firm that inspection or surveillance found violations significant enough to prompt enforcement action if not corrected promptly, issued to establish prior notice rather than as final agency action.