Australia Canada Singapore Switzerland (ACSS) Consortium - New Chemical Entities Work Sharing Trial Phase I
Published on June 27, 2018
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
Related Articles
Value-Based Drug Pricing in Canada and its Limitations
Drug pricing is a complex and controversial issue that often sparks debates among patients, pharmaceutical companies, and the government. Prices can vary significantly...
Addressing Underrepresentation in Clinical Trials: FDA's Diversity Action Plan
The U.S. Food and Drug Administration (FDA) released a new draft guidance in June 2024 to enhance the diversity of clinical trial participants. The guidance details the...
VIRTUAL HEALTHCARE IN CANADA
“Virtual care” is defined as any “interaction between patients and/or members of their circle of care, occurring remotely, using any forms of communication or...