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.

Assessment procedure

contains further details on this procedure.

The applicant should first express interest in the initiatives by using the or Biosimilar 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.

Each authority reviews the module or modules allocated to it for the main review. As soon as the main review of all modules is concluded, the evaluation reports will be shared via a secure IT platform. Modules will be peer reviewed by those participating authorities that have not conducted the initial main review. The authorities will then discuss the results in a teleconference and prepare a consolidated response to be communicated to the applicant.

Product labelling will not be part of the joint review process. There may be discussions among regulators about product labelling during the assessment phase, however regulators will review and determine this on a national basis, due to diverging regulatory and legal requirements.

Where the application is following the standard review pathway, clarification questions will be consolidated and sent to all local affiliates simultaneously. The timelines for this will be dependent on the milestones for the review agreed by the participating regulators. Questions specific to a given jurisdiction, such as those related to labelling, will be sent as needed and only to the local affiliate.