Australia and Canada add NCE applications to regulatory work-sharing agenda

The Australian Therapeutic Goods Administration (TGA) has set up a new chemical entity (NCE) work-sharing pilot with Canada’s drug regulator, Health Canada. TGA and Health Canada have decided to divide up the task of reviewing NCE filings with the aim of reducing their workloads and those of applicants. Benefits of the NCE work-sharing model include reducing the time involved for sponsors and agencies to complete the submission and review of approval fillings, resulting in medicines reaching patients in medium-sized markets sooner.

Australian and Canadian officials are entering into the pilot project as part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. The pilot project may expand to include all four agencies but currently the pilot is seeking applications from companies that want to file in Australia and Canada simultaneously.

Upon receipt of a common submission, TGA and Health Canada will divide up the work, for example each agency will evaluate its respective Module 1 and process Module 5, which covers the clinical matters separately. It has been decided that Health Canada will evaluate the quality-focused Module 3, and TGA will take the lead on the toxicology-related Module 4. TGA and Health Canada have stated that they would like applicants to include common information in Modules 2 to 5 but will allow some differences as long as they are highlighted prior to submission.

The pilot will allow TGA and Health Canada to assess whether single assessments will work in practice. Each agency plans to make the final approval decision for its jurisdiction but the review that supports the decision will feature contributions from its counterpart as well.

To read more about the ACSS – NCE work-sharing pilot, please click here.