A

• AAT
• abbreviated new drug application
• abbreviated new drug application number
• abbreviated new drug submission
• ABC analyses
• ABC value analyses
• ablate
• ablation zone
• abridged application
• absolute configuration
• absorption
• abstract message
• abstraction
• abuse of a medicinal product
• ACCA
• accelarated assessment
• accelerated development
• accelerated stability
• accelerated storage conditions
• accelerated testing
• acceptable exposure
• acceptable intake
• acceptable limit
• acceptable quality limit
• acceptance criteria
• acceptance criteria for software
• acceptance criteria for specimens
• acceptance criterion
• acceptance test
• access with evidence development
• accountability
• accreditation
• accreditation body
• accuracy
• ACK
• acknowledgement message
• acronym
• ACS
• act on application
• action letter
• action level
• action limit
• action plan
• activation
• active
• active comparator arm
• active implantable medical device
• active ingredient
• active marker
• active medical device
• active pharmaceutical ingredient
• active substance
• active substance gas
• Active Substance Manufacturer
• active substance master file
• active, not recruiting
• activity diagram
• actor
• acuity
• acute care
• ADA
• ADaM
• adanced therapy medicinal product
• adaptive design
• additive
• address
• adequate
• adequate and well-controlled study
• adequate and well controlled trial
• adequate provision
• adjuvant
• ADME
• administrable dosage form
• administrable dose form
• administration
• administration device
• administration method
• administration route
• administrative appeals tribunal
• admission criteria
• adopted name
• ADR
• ADR database
• ADUFA
• advanced electronic signature
• advanced notice of proposed rulemaking
• advanced therapy medicinal product
• adventitious agent
• adventitious agent safety
• adventitious virus
• adverse drug experience
• adverse drug reaction
• adverse effect
• adverse event
• adverse event following immunisation
• adverse event of special interest
• adverse experience
• adverse incident
• adverse reaction
• advertisement
• advertising and promotional labelling branch
• AE
• AED
• AEFI
• AEMPS
• aerosol
• aerosol foam
• aerosol generator
• aerosol powder
• aerosol spray
• affinity
• afmps
• AGDUFA
• agency for medicinal products and medical devices of croatia
• agency for medicinal products and medical devices of the republic of slovenia
• AGES
• agreement
• agreement on conformity assessment and acceptance of industrial products
• AI
• AIFA
• AIMD
• air monitoring
• air separation
• airlock
• alernate sample retention site
• alert limit
• algorithm
• alias
• alkaline elution assay
• allergens
• allocative efficiency
• allogeneic donation
• almp
• alpha error
• alphanumeric
• alternate sample retention site
• alternate source
• alternates
• ALU
• ambiguity
• amendment
• amendment protocol
• American Chemical Society
• American National Standards Institute
• American Standard Code for Information Interchange
• amino acid
• AMIS
• amniocentesis
• ampule
• analog
• analogous substitution
• analyses dataset
• analysis
• analysis dataset
• analysis set
• analysis set of subjects
• analysis variable
• analysis variables
• analyte
• analytical data
• analytical method
• analytical methods validation
• analytical procedure
• analytical run
• anatomical therapeutic chemical classification system with defined daily doses index
• anatomical therapeutic chemical code
• anchor
• ancillary human blood derivative
• ancillary medicinal substance
• ANDA
• ANDS
• aneuploidy
• anhydrous
• animal drug user fee act
• animal generic user fee act
• ANM
• ANMDM
• annotated case report form
• annotated ecg waveform data
• annual re-assessment
• annual review
• anonymization
• ANPRM
• ANSI
• ANSM
• anti-drug-antibody
• antibiotic resistance
• antibiotics
• antibody
• antibody screen
• anticipated efficacy benefit
• antigen
• antigenicity
• antimicrobial resistance
• antimicrobials
• antiseptic
• antiserum
• anual re-assessment
• anyalysis data model
• AP
• APEC
• API
• api starting material
• APLB
• applicable regulatory requirement
• applicant
• applicant's information
• applicant's part
• applicant's response to list of out-standing issues
• applicant's response to list of questions
• applicant address
• applicant name
• applicants submission unit type
• application
• application legal basis
• application number
• application program
• application software
• application specific software
• application status
• application type
• applicator
• appropriate
• approvable letter
• approval
• approval document
• approval history
• approval letter
• approval, institutional review boards
• approved name
• approved substance
• approver
• AQL
• arbitrary unit
• arbitration
• architecture
• archival database
• archive
• archive staff
• archivist
• arithmetic logic unit
• arm
• arm types
• array
• article 10b fixed combination application
• article 13b fixed combination
• article 58 application
• AS2
• ASCII
• ASEAN
• ASEAN PPWG
• asepsis
• aseptic area
• aseptic filling
• aseptic manufacturing area
• aseptic process
• aseptic processing facility
• aseptic processing room
• ASK number
• ASM
• ASMF
• ASR
• assay
• assertion
• assessment
• assessment report
• association of southeast asian nations pharmaceutical product working group
• associative relationship
• astigmatism
• asynchronous
• ATC
• ATC/DDD Index
• ATCvet
• ATMP
• attribute
• audit
• audit certificate
• audit findings
• audit plan
• audit programme
• audit recommendation
• audit report
• audit trail
• auditors
• auricular
• austrian agency for health and food safety
• author
• authorization
• authorization date
• authorization number
• authorization procedure
• authorization status
• authorized person
• authorized port-of-entry
• autologous donation
• automated system
• auxiliary storage