As part of its strategic initiative to make the Access Consortium a competitive and efficient submission pathway of choice for industry, it is offering joint pipeline meetings to pharmaceutical and biotechnology companies.[1]

The Access Consortium notes that these meetings will provide “an opportunity to exchange information on new developments and collaborate on new possibilities.”

Established in 2007, the Access Consortium is a collaborative initiative of governmental health authorities that regulate human medicines and other health products. As of May 2023, the Access Consortium consists of:

• Therapeutic Goods Administration, Australia;
• Health Canada, Canada;
• Health Sciences Authority, Singapore;
• Swissmedic, Switzerland; and
• Medicines and Healthcare products Regulatory Agency, United Kingdom.

The Access Consortium focuses on enhancing regulatory systems to enable work-sharing of applications as between regulatory bodies for the registration of medicines.[2]

Stakeholders who are interested in a pipeline meeting must submit a request by emailing one of the regulatory agencies (emails provided in the link at footnote 1). Importantly, the information discussed will remain confidential.

Topics for discussion at these meetings may include:

• Potential candidates for Access Consortium submissions, such as:
  • Biosimilars;
  • advanced therapy medicinal products;
  • generic developments for complex technologies; and
  • new active substance candidates for standard or priority review;
• Requirements for future Access Consortium submissions involving upcoming trends, new technologies and added complexities; for example:
  • real world evidence; and
  • complex trials;
• Collective indications; for example:
  • tropical diseases;
• Early identification of challenges or possible technical barriers for harmonized Access Consortium submissions; and

• Access Consortium submission strategy for novel therapeutic approaches.

   

Requesting a pipeline meeting provides a unique opportunity for stakeholders interested in these issues to have their voices heard by regulatory authorities.

If your company would like assistance preparing for a meeting, please reach out.

[1] https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/access-consortium/pipeline-meetings-pharmaceutical-biotechnology-companies.html

[2] https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/access-consortium/strategic-plan-2021-2024.html