Health Canada Forges Ahead With Five Transparency Proposals for Pharmaceuticals
In support of an ongoing effort to increase transparency, Health Canada intends to implement five proposals related to prescription drugs and biologics by 1 October.The proposals come from a division within Health Canada—the Health Products and Food Branch (HPFB)—as part of two 2015 transparency initiatives for drugs, biologics and medical devices.
Background
The Regulatory Decision Summary (RDS) initiative provides explanations for regulatory decisions to approve or reject the sale of certain medical products, whereas the Submissions Under Review (SUR) list “informs Canadians as to whether a drug product has been accepted for review in Canada,” the regulatory authority said in a Tuesday notice.
The five proposals on premarket transparency for prescription drugs stem from implementing Phase III of the RDS and SUR list initiatives, following a month-long consultation last fall. The consultation analysis found the majority of respondents believed the proposals would be useful.
In contrast with the US Food and Drug Administration, Health Canada previously pledged to publish negative decisions on certain new drug submissions (NDSs), supplemental new drug submissions (SNDSs) and Class IV medical device applications when it first announced its phased-in push for greater regulatory transparency in 2016.
Proposals
The first proposal involves publishing RDSs for the final positive and negative decisions on generic drug submissions (ANDSs) and on supplemental abbreviated new drug submissions (SANDSs) that HPFB considers to be of interest to stakeholders. Submissions would be subject to published RDSs in the event that HPFB “significantly deviates” from published guidance, involve critical dose drugs or complex substances and/or products.
“HPFB reviewers will identify potentially eligible submissions during review; management approval on eligibility will be sought and then sponsors will be notified individually,” Health Canada said.
Proposals two and three involve publishing a SUR list for ANDSs, separated from the current SUR lists for NDSs and SNDSs, and publishing RDSs for final positive decisions on SNDSs.
The SUR list for ANDSs will detail medicinal ingredients, therapeutic areas, and number of submissions, whereas the publishing of RDSs will be limited to “new routes of administration, dosage forms, and strengths for prescription pharmaceuticals and biologics,” Health Canada said.
Proposals four and five involve adding a company’s name to the list of submissions currently under review and seven submission classes for NDSs and SNDSs accepted for premarket reviews on or after 1 October 2018. New submission classes include new active substances and biosimilars.