This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted…

[FDA] A written communication to an applicant from FDA approving an application or an abbreviated application. Source: 21 CFR 314.3(b)

"A pharmaceutical company or its agent that is submitting information in support of an application." Source: Harmonised Technical Guidance for eCTD Submissions in the EU

[FDA] Post-NDA report (submission) providing the FDA with a summary of new research data, distribution information and labeling changes plus certain other information form manufacturers. These reports must be filed…

"Annotated ECG waveform data are raw voltage-versus-time data comprising the electrocardiogram recording, to which have been attached the identification of various intervals or other features." Source: Study Data Specifications (FDA)

An annotated case report form (CRF) is a blank CRF with annotations that document the location of the data with the corresponding names of the datasets and the names of…

The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted classification system for medicines that is maintained by the World Health Organisation (WHO). The WHO assigns ATC codes to all…

Analysis datasets are datasets created to support results presented in study reports, the ISS and the ISE and to support other analyses that enable a thorough regulatory review. Analysis datasets…

ADaM defines dataset and metadata standards that support efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data, and data represented in the…

"[FDA] Information submitted to a pending submission, including additional information or reanalysis of data previously submitted to clarify, revise or modify the application as originally submitted. Major Amendment - an…

An ingredient in a medicine that increases or modifies the activity of the other ingredients. Adjuvants are often included in vaccines to enhance the body’s immune response. Source: EMA Glossary

Documentation providing detailed information on the manufacturing of the active substance of a medicine. Source: Electronic Active Substance Master Files (eASMF)

The substance responsible for the activity of a medicine. See Drug Stubstance.

Active Pharmaceutical Ingredients (API) refers to an active ingredient that is contained in the medication. See Drug Stubstance.

Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the results of clinical trials. An…

An ANDA (ANDA) is an abbreviated version of an New Drug Application (NDA). It is allowed for duplicates of drug products that were first approved before October 10, 1962 and…

Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients. Adverse Drug Reaction: The detection, assessment, understanding and prevention of ADR are…