Notice: Australia Canada Singapore Switzerland (ACSS) Consortium - New Chemical Entities Work Sharing Trial Phase I

April 30, 2018

Our file number: 18-105461-801

Background

The Australia Canada Singapore Switzerland (ACSS) Consortium was established as a means to foster regulatory collaboration and synergy between regulators and to address emerging scientific and regulatory issues regarding health products.

The ACSS Consortium consists of several working groups with various objectives and projects that aim to help address the challenges faced by regulatory authorities, including timely access to safe therapeutic products within a limited resource capacity. The working groups use a network of bilateral confidentiality agreements and Memoranda of Understanding to conduct their work.

The New Chemical Entities (NCE) Working Group was formed to focus on developing opportunities within regulatory programmes through the greater alignment of regulatory approaches and technical requirements, more efficient use of resources through information sharing and the establishment of an effective network among trusted, like-minded regulatory authorities. With this in mind, the NCE Working Group is launching an innovative work sharing trial for the coordinated assessment of a NCE application.

This work sharing trial will involve the undertaking of a fully coordinated assessment of a single NCE application by the Health Products and Food Branch of Health Canada and the Therapeutic Goods Administration of Australia. The regulatory authorities of Singapore and Switzerland will participate as observers. This joint assessment will focus on the evaluation phase only and is not intended to replace the independent regulatory decision-making of each authority. The valuable knowledge and experience obtained through this initial trial will provide a greater understanding of the regulatory procedures of each consortium member to enhance future collaborations.

This is a truly unique global collaboration between regulatory authorities and the pharmaceutical industry. The potential gains from this initiative include a reduction in regulatory burden (e.g., with the filing of common dossiers, the potential for similar market authorisation dates between regions and consolidated questions to applicants)

Next Steps

Health Canada and the Therapeutic Goods Administration are inviting applicants interested in participating in this innovative work sharing trial to contact their domestic regulatory authority:

Communications via e-mail should include “ACSS Consortium - NCE Trial” in the subject line.

Health Canada
E-mail: HC.tpd.international-dpt.SC@canada.ca

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