Access Consortium: New Active Substance Work Sharing Initiative (NASWSI) Overview


The Australia, Canada, Singapore, Switzerland and United Kingdom (Access) Consortium new active substance work sharing initiative (NASWSI) offers a truly unique global collaboration between regulatory authorities and the pharmaceutical industry. With each application that is filed through this initiative, the Access Consortium is gaining valuable knowledge to be able to gain regulatory efficiencies and alignment in submission reviews. The potential advantages from this initiative to industry include a reduction in regulatory burden, similar market authorization dates between participating countries and consolidated questions to applicants. As this initiative matures, more information will become available to inform Industry of the Consortium's goal to establish a new and consistent pathway for the review of drug applications filed in two or more Access jurisdictions.

This work sharing initiative (previously known as New Chemical Entities work sharing initiative), may be considered for a new chemical entity (NCE) or a new biologic entity (NBE) application and for new indication(s) applications that are filed to two or more of the Access Consortium members. This may include applications that are seeking an approval via the priority review pathway or a Notice of Compliance with conditions (NOC/c). For the applications following the priority review pathway to be eligible for the initiative, the application must have priority status in each Access jurisdiction where the application is to be filed as part of the initiative.

The Consortium uses a network of bilateral confidentiality agreements and Memoranda of Understanding to share information. Any information that is shared is done through a secure collaborative document storage and management platform that is only accessible by authorized members of the Consortium.

Application Process

A domestic application will need to be submitted to each participating regulator. While it is preferable for the application to be identical, modules 2-5 can differ in the applications submitted to each participating regulator.

Where there are differences in the application, the 'Summary of differences between dossiers' (included in the Expression of Interest form) should be completed to outline the differences in information provided to each regulator. The participating regulators may discuss these differences with the applicant to determine if the application is suitable for the work sharing initiative. Applications should be submitted to each regulator simultaneously or as agreed with the regulators. If applicable, the Active Substance Master File/Drug Master File (ASMF/DMF) must be submitted to each participating regulator in advance of filing of the application with the appropriate local forms.

The Health Canada application must be in eCTD format.

Interested applicants are invited to participate by contacting their regional regulatory authority.

Communications via email should include "Access Consortium - NASWSI" in the subject line.

For more information on the process, please read the Operational Procedure for New Active Substances Work-Sharing Initiative (NASWSI)

Joint Review

The joint review of a NCE or NBE among participating regulators will involve a division of labour that will be determined at the time of filing. For example, if the joint review is being conducted by Health Canada (HC) and the Therapeutic Goods Administration of Australia (TGA), the joint work could consist of HC evaluating module 3 data, the TGA evaluating module 4 data, and either regulators assessing module 5. Each regulator will evaluate its assigned modules, and will discuss issues and share the outcomes via scheduled teleconferences throughout the assessment period.

Product labeling will not be part of the joint review process. There may be discussions among regulators about product labelling during the assessment phase, but it is understood that different laws and frameworks exist among the countries which will ultimately affect regulatory decisions that are made on the final text and product labelling. It is likely that product labelling will differ from one jurisdiction to another.

Where the application is following the priority review pathway, any clarification questions that are raised during the assessment period will be sent to the respective local affiliate for a response. The clarification questions will also be shared with the partnering regulator and their local affiliate to allow for a subsequent eCTD sequence to be sent to ensure that the application is complete for all participating regulators.

Where the application is following the standard review pathway, clarification questions will be consolidated and sent to all local affiliates simultaneously based upon the milestones for the review established jointly 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.

Although it is anticipated that the joint review may lead to the same decision, each regulator will maintain its independence for decision making. Market authorisation or refusal by one regulator will not affect the decision or the timing of the decision of the remaining participating regulators.

In Canada, the same performance standards that apply to the HC regular review process will also apply to joint reviews. As stated earlier, each regulator will retain the ability to make its own decision regarding the drug application. HC would make every effort to meet the performance standards laid out in the Management of Drug Submission Guidance document for that application.

Post Review

Following the completion of the review process, the Summary Basis of Decision (SBD) and Regulatory Decision Summaries (RDS) documents will be written by Health Canada and will contain information that speaks to the product assessment having undergone a joint review process. Other countries may have a similar post decision documents that will convey a similar message.

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