The 25-page draft updates a 2008 draft and contains primarily administrative revisions developed to facilitate information-sharing initiatives that are ongoing in collaboration with the International Generic Drug Regulators Program (IGDRP), including changes to terminology to be consistent with IGDRP. It also introduces process changes that the agency maintains “are less cumbersome on industry and Health Canada.” Included are clarifications of various timelines and encouragement to industry to file Certificates of Suitability (CEPs).
The draft also notes that “all quality changes to master files are now called updates and these are only required when a Supplement to an Abbreviated New Drug Submission [(A)NDS], Notifiable Change (for biologics), CTA-Amendment or CTA-Notification need to be filed with Health Canada.” The public consultation runs until April 14, 2016.
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More Information on Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements