Access, new active substance and biosimilar work sharing initiatives

The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.

By engaging in these partnerships, Access is able to co-ordinate regulatory review procedures, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.

The Operational Procedures for the New Active Substance Work Sharing Initiative (NASWSI) (PDF, 340 KB, 13 pages) contains further details on this procedure. The applicant should first express interest in the initiatives by using the NAS Expression of Interest Form (MS Word Document, 169 KB) or Biosimilar Expression of Interest (EOI) form (MS Word Document, 177 KB) to the relevant authorities. This should be done 3 - 6 months before the target submission date.

The applicant must then submit identical dossiers (while taking country-specific aspects into account) to the relevant authorities participating in the work sharing initiative. Where possible, this should be done within a time frame of two weeks.

The application to the MHRA must be in eCTD format and in accordance with UK regulatory requirements. Modules 2 to 5 do not have to be identical across countries, but it is preferable that the same dossiers are submitted to all the participating regulators. Where there are differences, the ‘Summary of differences between dossiers’ (included in the EOI form) should be completed outlining the differences in information provided to each regulator.