Author: Bhavesh Patel, C. Chem.
Health Canada has recently requested feedback on a Phase III premarket transparency initiative to include the name of the sponsor on the list of new drug submissions and supplements for new uses currently under review.
Phase III includes the launch of a new list of Abbreviated New Drug Submissions (generic submissions) that were accepted into review on or after October 1, 2018. The list is called the Generic Submissions Under Review List and includes the medicinal ingredient(s), therapeutic area, and number of submissions. Similar to the first phases of the Submissions Under Review Lists for New Drug Submissions and Supplemental New Drug Submissions for new uses, the new Generics Submissions Under Review List did not include the name of the sponsor (generic company) that filed the ANDS.
Health Canada has requested the feedback on possible impacts and uses to stakeholders if sponsor (generic company) names were to be added to the Generic Submissions Under Review List.
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Bhavesh Patel is an active member of CAPRA Education Day and Website Committee and has been working with CAPRA for 10 years. Bhavesh has 10 years of experience in Regulatory Affairs in Canada. His regulatory experience encompasses prescription drugs, non-prescription drugs, natural health products, medical devices, cosmetics and foods. In his spare time, he enjoys professional writing, which includes regular contributions to the CAPRA online Blogs. Recently, Bhavesh co-authored chapters for the RAPS 2018 book, “Fundamentals of Canadian Pharmaceutical and Biologics Regulations”.