A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or National Medical Products Association (NMPA) in China.
As part of certain drug and medical device applications to regulatory agencies, a company may need to reference data from another product used in the manufacture of their own, such as packaging, ingredients, or accessories. The owner of this data may choose to submit a Master File to disclose proprietary or confidential information concerning their product to a regulatory agency without providing it to parties that need to reference it.
Many agencies require submission of Master Files in electronic common technical document (eCTD) format.
Drug Master Files (DMFs) and Active Substance Master Files (ASMFs)
Submissions of proprietary information on human drugs and substances, including information on:
Medical Device Master Files (MAFs)
Submissions of proprietary information on medical devices, including information on:
Veterinary Master Files (VMFs)
Submissions of proprietary information on veterinary drugs and substances, including information on:
Health Canada
U.S. Food and Drug Administration (FDA)
United Kingdom
Chinese National Medical Products Administration (NMPA)
European Union
Australia · Bahrain · Bosnia and Herzegovina · Hungary · Jordan · Kuwait · Oman · Qatar · Saudi Arabia · South Africa · Switzerland · United Arab Emirates · WHO (World Health Organization)
