Navigating the regulatory landscape can be challenging if you’re not familiar with all the terms. Find a list of some of the key regulatory terms, processes, acronyms, and their definitions below.

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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

 

A

An application seeking the FDA’s approval of a generic drug product. These types of applications do not generally need to include preclinical and clinical data, but instead must demonstrate that the product performs in the same manner as the innovator drug.
Also known as the drug substance, the API is the biological molecule that is responsible for the action or efficacy of the drug.

B

The marketing approval application (MAA) that’s filed in the USA for the commercial manufacturing of biologics. This application contains specific data on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and medical effects of the biologic product.

C

How to maintain compliance and achieve operational excellence in your quality system through a corrective and preventive action process.
The center within the FDA that regulates biological products for human use under applicable federal law.
The center within the FDA that regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
A service provider for biotherapeutics development and manufacturing.
A database including a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.
An alternative way of referring to good manufacturing processes (GMP).
This term can refer to a major part of the ‘quality’ module within the common technical document (CTD). This section is there to ensure consistency within the manufacturing process, and it should contain all relevant data on the active pharmaceutical ingredient (API), the drug product, and the placebo (if used).

A document provided in manufacturing that reports on the quality assessment of the production lot.

A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate range to ensure the quality of the product.

A paper or digital document created and used in clinical trial research to collate standardized clinical data from each patient and transfer this data to Data Management.

The regulatory application format used internationally to seek new drug approval. This must contain all information relevant to demonstrate that the proposed clinical trial can be conducted safely as planned, and later on, that the drug will be safe for market.

The extensive electronic or paper document where the CTA (or IND in the USA) is organized, which is submissible within all regions and to all regulatory bodies.

D

A systematic method to determine the relationship between factors affecting a process and the output of that process. It is used to find cause-and-effect relationships through the design of experiments.

A submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

E

An electronic submission of the common technical document (CTD).
The European Union’s decentralized agency that is in charge of evaluating and supervising medical products for use in the European Union.
The Food and Drug Administration (FDA)’s ESG is an agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and post-market regulatory information for review.

F

A federal agency of the Department of Health and Human Services (USA) that protects and promotes public health through the control of various areas of manufacturing.
The first tests conducted in humans as part of the regulatory process. This will occur in Phase I.

G

Internationally recognized ethical and scientific quality requirements that must be applied when designing, conducting, recording, and reporting clinical trials involving people. The ICH provides guidance on this.
The guidelines that one follows in recording raw data entries in a legible, traceable, and reproducible manner.
The quality control system designed to minimize the risks involved in any manufacturing process that cannot be eliminated through testing the final product. It ensures biological products are tested and dosed for optimal effectiveness.
The part of quality assurance that adequately controls the storage of pharmaceutical products.
A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.

The specific requirements a company outlines for its warehouse, storage and shipping facilities, and departments.

I

A brief description of the product being manufactured, including a summary of the animal studies and any clinical evidence. This is common to all countries and is used by the physician leading the trial to capture what has been learned about the drug.
A committee that joins regulatory authorities and the pharmaceutical industry together to discuss the scientific aspects of pharmaceutical development and registration.
Allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. (Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.) An approved IDE means that the independent review board (IRB) has approved the sponsor’s study application.
The specific documentation used to seek new drug approval from regulatory bodies in the EU and UK. This will use the clinical trial application (CTA) format.
The specific documentation used to seek new drug approval from regulatory bodies in the USA. This will use the clinical trial application (CTA) format.
An exit to an investment whereby the company sells its shares to public shareholders, resulting in liquidity for shareholders.
A group formally designated by an institution to review biomedical research involving human subjects, in order to assure the protection of the rights, safety, and welfare of human subjects.

M

The end approval sought in the regulatory process so that the drug can be sold commercially using an approved manufacturing process.

N

The marketing approval application (MAA) filed in the USA for small molecule biologics. This application will be submitted to the FDA once the sponsor believes they have obtained enough evidence on the drug's safety and effectiveness to meet the FDA's requirements. If approved, the product may be marketed in the United States.
The difference between the present value of cash inflows and outflows over a period of time.

P

The realization of a certain idea to demonstrate its feasibility.
Part of process qualification that produces commercial batches by combining the actual facility, utilities, equipment, and trained personnel with the commercial manufacturing process, control procedures, and components.
The design of the facility and qualification of the equipment and utilities.
A report that goes into the CMC section of the common technical document (CTD) and demonstrates that the manufacturing processes are validated.

Q

The process that defines the standards to be followed in order to meet the quality requirements for a clinical trial. This constitutes part of the quality management system (QMS).
A systematic approach to pharmaceutical development and manufacturing which aims to ensure quality by applying statistical, analytical, and risk-management methodology in product design, development, and manufacturing.
Ensures that the standards defined in quality assurance (QA) are followed at every step. This constitutes part of the Quality Management System (QMS).
A manual stating the management's intentions for operating the QMS. It includes policies for all areas of the business affecting or affected by the QMS.
A system made up of quality control (QC) and quality assurance (QA), two distinct functions working simultaneously from the beginning of operations.
The systematic process for assessing, communicating, and reviewing risks to the quality of a pharmaceutical product across its life cycle.

S

A set of instructions outlined by an organization for workers to carry out routine operations, as part of quality control.
An agreement that indicates concurrence by the FDA, with the adequacy and acceptability of specific critical elements of overall protocol design (for example, entry criteria, dose selection, endpoints, and planned analyses) for a study intended to support future marketing.

T

A collection of documents and images related to the clinical trial that must be stored and maintained in order to comply with governmental regulations.