Glossary
ADME
An acronym in pharmacology and pharmacokinetics for Absorption, Distribution, Metabolism, Excretion.
ANDA
Abbreviated New Drug Application, the application procedure to approve a generic drug in the US.
API
Active Pharmaceutical Ingredient
ASMF
The Active Substance Master File is a document containing complete information on an Active Pharmaceutical Ingredient.
BLA
Biologics Licence Application An application to approve biologics in the US.
CBER
Center for Biologics Evaluation and Research; CBER is the department within FDA that regulates biological products for human use.
CDER
Center for Drug Evaluation and Research; CDER is the department within FDA that regulates over-the-counter and prescription drugs, including certain biological therapeutics and generic drugs for human use.
CEP
Certificate of Suitability of the Monograph of the European Pharmacopoeia, a certification procedure with the purpose of providing proof that the quality of the substances used in human and veterinary medicines are suitably controlled by the relevant monographs of the European Pharmacopoeia.
CHMP
Committee for Medicinal Products for Human Use (formerly known as Committee for Proprietary Medicinal Products - CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.
CTA
Clinical Trial Application
CTD/eCTD
Common Technical Document (electronic CTD) is a set of harmonised structure and format specifications for application dossiers for the registration of medicines and designed to be used across Europe, Japan and the US.
DMF
Drug Master File is a document containing complete information on an Active Pharmaceutical Ingredient or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) in Europe and US-Drug Master file (US-DMF) in the US.
EC
Ethics Committee; required in EU for approval of clinical trials
EMA
European Medicines Agency
EPAR
European Public Assessment Report - once a medicine has been granted a Community marketing authorisation by the EC, EMA publishes a full scientific assessment report.
FDA
Food and Drug Administration, US
IB
The Investigator’s Brochure is a comprehensive document summarizing the body of information about an investigational product and thus is a document of critical importance throughout the drug development process. It has to be regularly updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials.
ICH
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration with the purpose to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
IMPD
Investigational Medicinal Product Dossier is the basic document or set of documents required for the approval of clinical trials by the competent authorities in the EU.
IND
Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines in the US (usually to clinical investigators), being in practice the permission required for clinical investigations in the US.
IRB
Institutional Review Board; US equivalent to the Ethics Committee in EU
IQ/OQ/PQ
Installation Qualification, Operational Qualification, Performance Qualification, measurements required for the qualification of laboratory equipment.
MAA
Marketing Authorisation Application
NDA
New Drug Application, the application to approve a drug in the US.
PDCO
Paediatric Committee of EMA, responsible for the assessment of paediatric investigation plans
PI/PIL
Package Insert or Patient Information Leaflets are documents containing specific information about medical conditions, doses, side effects that are packed with medicines to give the user information about the product. PIL is the European version of the PI.
PM
Project Management, the discipline of planning, organizing, securing and managing resources to bring about the successful completion of specific project goals and objectives.
SME
Small & Medium Enterprises
SPC or SmPC
Summary of Product Characteristics, a specific document required by EMA summarising the key characteristics of a drug for which a Community marketing authorisation has been granted.
Value Dossier
The Value Dossier is requested in Germany for any new product at time of market launch or for marketed drugs which are still under document protection. The objective is to document the “additional therapeutic benefit” vs. an “appropriate standard therapy” as platform for price negotiations. The content of the Value Dossier is linked to the Regulatory File. Therefore, it is mandatory that all regulatory actions have to be carefully considered vs. its impact on the value dossier and vice versa.