In its Common Drug Review Update – Issue 133, which was published on February 13 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced revisions to its biosimilar and administrative review process.(1) The update:

  • revised the CADTH's biosimilar process, creating a streamlined approach for biosimilar reviews through shorter timelines, fewer submission requirements and abbreviated biosimilar summary dossier templates;
  • made application fees applicable to all Common Drug Review submissions and resubmissions irrespective of the notice of compliance or notice of compliance with conditions issuance date;
  • introduced new fee guidance for pharmaceutical review programmes, which includes a new reduced fee for the new biosimilar review process and an annual fee adjustment based on the consumer price index; and
  • introduced new patient input templates for biosimilars, which offer specific prompts for biosimilar review.

Other updates include the issuance of new administrative forms, such as:

  • a revised pre-submission information requirements form for advanced notice;
  • a revised application overview template; and
  • updated contact information.

For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (khlee@smart-biggar.ca). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.

Endnotes

(1) Further details are available here.

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