Author: Karen Zhou
The Australia Canada Singapore Switzerland (ACSS) Consortium was established to foster collaboration and synergy between regulatory authorities to address common scientific and regulatory challenges. The consortium consists of several working groups with various projects that aim to address current regulatory issues such as timely access to safe therapeutic products within a limited resource capacity.
The New Chemical Entities (NCE) Working Group was formed by ACSS as part of an effort to develop regulatory programs through a greater alignment of regulatory approaches and technical requirements, more efficient use of resources, and the establishment of an effective network among liked-minded regulators. The group is launching a work-sharing trial for the coordinated assessment of NCE applications by Health Canada and TGA, with Singapore and Switzerland participating as observers. The joint assessment will focus on the evaluation phase only. However, the joint assessment is not intended to replace the independent decision-making of each regulatory authority. The results of the initial trial provide the knowledge and experience that will strengthen understanding of regulatory procedures of each jurisdiction to enhance future collaborations. Among the potential benefits from this initiative is a decreased regulatory burden.
Health Canada and TGA are inviting applicants interested in this work-sharing trial to contact their domestic regulatory authority. If you are an industry member interested in participating in the work-sharing trial, please contact the regional contact for Canada at: HC.tpd.international-dpt.SC@canada.ca
Reference:
Notice: Australia Canada Singapore Switzerland (ACSS) Consortium - New Chemical Entities Work Sharing Trial Phase I (April 30, 2018) https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/notice-acss-new-chemical-entities-trial-phase-1.html