ICH Terms (150)

FDA regulations governing electronic records and electronic signatures to ensure their trustworthiness and reliability.

A US NDA pathway that relies, at least in part, on FDA's findings of safety and effectiveness for a previously approved drug or published literature.

A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.

A 510(k) pathway that relies on FDA guidance documents, recognized consensus standards, or special controls to establish substantial equivalence.

An application for FDA approval of a generic drug product that references an already-approved drug.

An FDA pathway allowing earlier approval based on surrogate or intermediate endpoints for serious conditions.

The substance in a pharmaceutical drug that is biologically active and produces the intended therapeutic effect.

A clinical trial design that allows pre-planned modifications to aspects of the trial based on accumulating data, while maintaining trial integrity and validity.

Any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product.

A yearly report submitted to FDA summarizing changes and updates to an approved drug application.

A clinical trial design that tests one investigational therapy across multiple indications or tumor types sharing a common molecular target or biomarker.

A comprehensive document containing all information and instructions for manufacturing a specific batch of drug product.

The ability of a medical device material to perform its intended function without causing adverse biological response in contact with tissue, blood, or other body fluids.

The absence of a significant difference in the rate and extent to which the active ingredient in two pharmaceutically equivalent products becomes available at the site of drug action.

A submission to the FDA requesting approval to market a biological product in the United States.

FDA's program that inspects clinical investigators, sponsors, IRBs, and nonclinical laboratories to verify compliance with applicable regulations.

A biological product highly similar to an FDA-approved reference biologic with no clinically meaningful differences in safety, purity, and potency.

A higher regulatory designation than biosimilarity, requiring demonstration that a biosimilar can be substituted for its reference product without intervention from the prescribing physician.

A clinical trial design technique where participants, investigators, or both are prevented from knowing which treatment each subject is receiving.

The strongest warning that FDA requires in prescription drug labeling, highlighting serious or life-threatening risks.

An FDA designation for drugs showing substantial improvement over existing treatments for serious conditions.

A clinical study conducted to allow extrapolation of efficacy and safety data from one region or population to another.

The FDA center responsible for regulating biological products including vaccines, blood products, and cell and gene therapies.

The FDA center responsible for ensuring the safety and effectiveness of medical devices and radiation-emitting products.

The FDA center responsible for ensuring that drugs marketed in the United States are safe and effective.

The section of a regulatory submission describing a drug's composition, manufacturing process, and quality controls.

Low-risk medical devices subject to general controls and, in most cases, exempt from 510(k) premarket notification.

Moderate-risk medical devices subject to general controls plus special controls, typically requiring 510(k) premarket notification.

Highest-risk medical devices requiring Premarket Approval (PMA) based on clinical evidence of safety and effectiveness.

An FDA order to a sponsor to delay a proposed or suspend an ongoing clinical investigation due to safety concerns or deficiencies.

A regulatory submission to EU or non-US authorities seeking authorization to conduct a clinical trial of an investigational medicinal product.

A therapeutic product combining two or more regulated components (drug, device, biologic) with a primary mode of action determining the lead FDA center.

An internationally harmonized format for organizing pharmaceutical regulatory submissions into five standardized modules.

An analytical method published in an official pharmacopoeia (USP, Ph. Eur., JP) that serves as the recognized standard for testing a specific article.

An FDA letter indicating that an application review is complete but the application is not approved as submitted.

A company that provides outsourced research services to pharmaceutical and biotechnology companies.

The planned set of controls, derived from product and process understanding, that ensures process performance and product quality.

A systematic approach to identifying, investigating, and addressing the root causes of quality problems.

A process parameter whose variability has an impact on a Critical Quality Attribute and therefore must be monitored or controlled to ensure product quality.

A physical, chemical, biological, or microbiological property of a drug substance or product that must be within an appropriate range to ensure quality.

The current quality standards FDA enforces for the manufacture, processing, packing, and holding of drug products to ensure identity, strength, quality, and purity.

The completeness, consistency, and accuracy of data throughout its lifecycle, following ALCOA+ principles.

An independent group of experts that periodically reviews accumulating clinical trial data to monitor participant safety and trial integrity.

A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.

A clinical trial where some or all trial activities take place at locations other than traditional research sites, often including patient homes.

Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.

The multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality, enabling operational flexibility within the defined region.

An annual comprehensive safety report submitted by sponsors of investigational drugs to regulatory authorities summarizing the safety profile during the reporting period.

A departure from an approved procedure, specification, or established standard during manufacturing or testing.

A confidential document submitted to FDA containing detailed information about manufacturing facilities, processes, or components.

A standardized electronic format for organizing and submitting regulatory applications to health authorities worldwide.

FDA's interactive PDF template required for all 510(k) submissions and extended to De Novo classification requests.

Inorganic impurities, principally heavy metals, that may be present in drug products and require assessment under ICH Q3D.

Analytical testing to quantify bacterial endotoxins in parenteral drugs, medical devices, and other products where endotoxin presence could cause pyrogenic reaction.

The formal written report FDA issues at the conclusion of a facility inspection documenting findings and classification.

The EU GMP annex establishing requirements for the manufacture of sterile medicinal products.

The EU GMP annex establishing requirements for computerized systems used in GMP-regulated activities.

The European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

An inactive substance used as a carrier or vehicle for the active pharmaceutical ingredient in a drug product.

The pathway for patients with serious or immediately life-threatening diseases to access investigational medical products outside of clinical trials.

An FDA program designed to facilitate development and expedite review of drugs treating serious conditions and filling unmet medical needs.

A list of inspectional observations issued by FDA investigators at the end of a facility inspection when conditions may violate the FDCA or related acts.

The first clinical trial in which an investigational product is administered to human subjects, typically as a Phase 1 study.

The US federal agency responsible for protecting public health by regulating food, drugs, biologics, medical devices, and cosmetics.

International ethical and scientific quality standards for designing, conducting, and reporting clinical trials.

The quality system covering the organizational process and conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, and reported.

Regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards.

Canada's federal department responsible for regulating drugs, medical devices, and other health products.

The application of usability knowledge to medical device design to minimize use-related hazards and support safe, effective operation.

The ICH guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

The international standard defining software lifecycle processes for medical device software.

A medical device used to perform tests on samples taken from the human body to detect diseases, conditions, or infections.

The nonclinical studies a sponsor conducts to support the safety and feasibility of initiating human clinical trials under an IND.

The process by which a research participant learns about and agrees to participate in a clinical trial after understanding the risks, benefits, and alternatives.

An independent committee that reviews and approves research involving human subjects to ensure ethical standards and participant protection.

A global organization that develops harmonized pharmaceutical guidelines to ensure drug quality, safety, and efficacy.

FDA authorization allowing an unapproved medical device to be used in a clinical investigation to collect safety and effectiveness data.

An application to the FDA to begin clinical trials of a new drug in humans.

A comprehensive document summarizing clinical and nonclinical data on an investigational product for clinical trial investigators.

The international standard for application of risk management to medical devices across the full product lifecycle.

All written, printed, or graphic matter on or accompanying a drug or device, including the package insert and promotional materials.

FDA-granted periods during which generic or biosimilar competition is delayed for certain approved drugs and biologics.

The formal application to the European Medicines Agency or EU national authorities seeking authorization to market a medicinal product in the EU.

A single overarching clinical trial protocol designed to evaluate multiple therapies, multiple indications, or multiple populations in a coordinated framework.

FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.

A standardized medical terminology used internationally by regulatory authorities and the pharmaceutical industry for coding adverse events and medical history.

The United Kingdom's regulatory agency for medicines, medical devices, and blood components.

FDA's program for reporting serious adverse events, product quality problems, and therapeutic inequivalence for human medical products.

The lowest dose at which a biologic is anticipated to produce any pharmacologically meaningful effect in humans, used as the basis for first-in-human starting dose for high-risk products.

FDA's 5-year marketing exclusivity for the first approval of a drug containing a novel active moiety.

A formal request to the FDA for approval to market a new pharmaceutical drug in the United States.

A class of genotoxic impurities that can form during drug substance or drug product manufacturing and require risk assessment and control.

The highest dose in a toxicology study that does not produce a statistically or biologically significant adverse effect compared to controls.

FDA's publication identifying drug products approved on the basis of safety and effectiveness with associated therapeutic equivalence evaluations.

A status granted to drugs intended to treat rare diseases affecting fewer than 200,000 people in the US.

A test result that falls outside the established acceptance criteria or specifications.

A structured clinical narrative describing the adverse event experience of an individual trial subject, required in clinical study reports.

An outcome measure that comes directly from the patient about their health condition without interpretation by a clinician or anyone else.

A six-month extension of existing market exclusivity and patent terms granted by FDA in return for completing pediatric studies requested by the agency.

The EU regulatory requirement for sponsors to submit a plan for pediatric development of a medicinal product to EMA's Paediatric Committee.

The FDA-required plan for pediatric development of a drug or biologic, submitted as part of NDA and BLA applications.

A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.

A periodic report summarizing the global safety profile of a marketed medicinal product.

Japan's regulatory agency responsible for approving pharmaceuticals, medical devices, and regenerative products.

The study of a drug's biochemical and physiological effects on the body and the mechanisms underlying those effects.

The study of how a drug moves through the body: absorption, distribution, metabolism, and excretion over time.

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.

The document describing the pharmacovigilance system operated by a Marketing Authorization Holder for EU-approved medicinal products.

The first stage of clinical testing in humans, primarily assessing safety, tolerability, and pharmacokinetics.

Clinical trials evaluating a drug's efficacy and optimal dosing in patients with the target disease.

Large-scale pivotal trials that confirm a drug's efficacy and safety to support regulatory approval.

A study or clinical trial that a sponsor has agreed to conduct as a commitment to FDA but is not required by statute or regulation.

An FDA facility inspection conducted before approval of an NDA, BLA, ANDA, or equivalent to verify cGMP readiness and submission accuracy.

A meeting with FDA to discuss regulatory questions before submitting a marketing application.

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

US legislation that allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.

The main outcome measure of a clinical trial, selected before the trial begins and used as the primary basis for the trial's conclusion about efficacy.

An FDA designation that reduces the review time for drugs treating serious conditions and providing significant improvement over available therapy.

A framework for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes.

Documented evidence establishing high confidence that a process consistently produces a product meeting specifications.

Documented evidence that a process consistently produces a product meeting predetermined specifications and quality attributes.

A formal modification to an approved clinical trial protocol requiring documentation, IRB approval, and where applicable regulatory notification or approval.

FDA's database of biological products licensed under the Public Health Service Act, including originator biologics and biosimilars.

FDA's formal mechanism for device sponsors to obtain feedback on development plans, submission content, or regulatory strategy before filing.

The designated EU-based individual responsible for the establishment and maintenance of a Marketing Authorization Holder's pharmacovigilance system.

A written document defining the cGMP responsibilities and activities between a drug owner and contract manufacturer or testing facility.

A systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

A prospective summary of the quality characteristics a drug product should possess to deliver the intended therapeutic benefit to the patient.

Clinical evidence about the use, potential benefits, or risks of a medical product derived from analysis of real-world data.

An FDA-approved drug product identified in the Orange Book that a generic drug sponsor relies on for an Abbreviated New Drug Application.

FDA's decision not to accept a 510(k) submission for substantive review due to administrative or completeness deficiencies.

FDA's decision not to accept a drug or biologic marketing application for substantive review due to administrative or content deficiencies.

A drug safety program required by FDA for certain medications with serious safety concerns to ensure benefits outweigh risks.

A document describing safety activities to identify, characterize, prevent, and minimize risks relating to medicinal products.

An adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.

The process of identifying new or changing safety information from pharmacovigilance data that may require further investigation.

The set of activities performed to detect, validate, confirm, analyze, prioritize, assess, and manage safety signals for a medicinal product.

An expedited 510(k) pathway for device modifications made by the original manufacturer of a previously cleared device.

Testing to determine how a drug product's quality changes over time under the influence of environmental factors.

The FDA determination that a new medical device is as safe and effective as a legally marketed predicate device, allowing 510(k) clearance.

The formal process of evaluating and approving suppliers of materials, components, and services used in GMP-regulated manufacturing.

A serious adverse event suspected to be related to the investigational product that is not expected based on the current Investigator's Brochure.

Switzerland's regulatory authority for therapeutic products including medicines and medical devices.

The documented process of moving manufacturing technology and knowledge from one site or party to another to enable production at the new location.

Australia's regulatory agency for therapeutic goods including prescription medicines, medical devices, and biologicals.

The standard 510(k) premarket notification pathway for Class II devices demonstrating substantial equivalence to a predicate.

A clinical trial design that tests multiple investigational therapies against a single disease, typically with biomarker-driven patient assignment to treatment arms.

A system for identifying medical devices through their distribution and use using a unique numeric or alphanumeric code.

An official FDA notice of significant regulatory violations requiring prompt corrective action.