Glossary

  • 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, is an application to approve biologics in the US.
  • CBER – Center for Biologics Evaluation and Research, is the department within Food and Drug Administration (FDA) that regulates biological products for human use.
  • 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.
  • CMC – Chemistry, Manufacturing, and Controls
  • CTA – Clinical Trial Application
  • CTD – Common Technical Document, 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.
  • eCTD – electronic Common Technical Document
  • 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.
  • EAMS – Early Access for Medicine Scheme (UK)
  • 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 Ethics Committee, EMA publishes a full scientific assessment report.
  • ERA – Environmental Risk Assessment
  • FDA – Food and Drug Administration (US)
  • IB – Investigator Brochure, is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.
  • 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.
  • MAA – Marketing Authorisation Application
  • MHRA – Medicines and Healthcare products Regulatory Agency (UK)
  • NDA – New Drug Application, the application to approve a drug in the US.
  • ODD – Orphan Drug Designation: a status assigned to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.
  • PDCO – Paediatric Committee of European Medicines Agency (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.
  • PIP – Paediatric Investigation Plans
  • PRIME – Priority Medicines program (EU)
  • RA – Regulatory Affairs
  • SME – Small and Medium Enterprises
  • SPC or SmPC – Summary of Product Characteristics, a specific document required by European Medicines Agency (EMA) summarising the key characteristics of a drug for which a Community marketing authorisation has been granted.