Dosage Forms
A solid pharmaceutical form manufactured by compressing uniform volumes of particles.
What is a tablet.
DMF
What is a Drug Master File
CEP stands for this.
What is Certificate of Suitability
This regulatory division supports the review bureaus
What is the Regulatory Project Management Division (RPMD)
F&DA
What is the Food and Drugs Act
A solid pharmaceutical form within either a hard or soft soluble container or “shell” made of gelatin or other substance.
What is a Capsule
ASMF
What is a Active Substance Master File
Benefit of a CEP
What is reduce review time and/or number of quality deficiencies
BPS
Who is Bureau of Pharmaceutical Sciences
OPPRS
What is the Office of Planning, Performance and Review Services
A liquid preparation of API dissolved in a suitable solvent.
What is a Solution
This type of DMF is for container closure systems or components.
What is Type II
What a CEP is filed for
Drug Substance / Active Pharmaceutical Ingredient (API)
BCANS
Who is the Bureau of Cardiology, Allergy and Neurological Sciences
OPML
What is the Office of Patented Medicines and Liaison
A liquid pharmaceutical form that contains an API which consists of solid particles dispersed through a liquid phase in which the particles are not soluble.
What is a Suspension
This type of DMF is for Excipients, colourants, flavours and other additives, including alum and growth media.
What is Type III
CEPs are granted by this regulatory authroity
Who is EDQM
BGIVD
Who is the Bureau of Gastrointestinal, Infectious and Viral Diseases
BRDD
What is the Biologic and Radiopharmaceutical Drugs Directorate
A drug delivery system that contains an adhesive backing and that permits the API to diffuse from some portion of it into the body from the site where it is applied.
What is a Patch
This group administers Master File fees and Applicant Access.
Who is the MF Unit
EDQM stands for this
What is European Directorate for the Quality of Medicines and Healthcare
BMORS
Who is the Bureau of Metabolism, Oncology and Reproductive Science
ROEB
What is the Regulatory Operations and Enforcement Branch