The ACCESS - Generic Medicine Work-Sharing Initiative (GMWSI) pathway has been developed by the ACCESS Consortium of ACCESS Worksharing Program.

This pathway can be used where To be considered for this initiative, the proposed product should be regarded as a generic product by all the participating agencies. All pharmaceutical (dosage) forms are eligible..

This pathway accelerates the regulatory review process.

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Australia Canada Singapore Switzerland United Kingdom

The GMSWI requires the sponsor to submit an EoI to each consortium member that the sponsor intends to submit an application to. This needs to be filed at least three months before the application filing date. The expectation will be that the same modules 2-5 are going to be submitted to each participating agency. However, differences, if any, must be listed on the EoI's summary-of-differences table. Sponsors can demonstrate that their application/product is equivalent to the reference product, so Access Consortium accepts foreign comparator products in bioequivalence studies with justification for it. Under the GMWSI initiative, the sponsor may submit a request for a proposed RRA, but the Access Consortium will determine the RRA and CRA's after assessing the operational needs. Once the EoI has been submitted, the consortium will assess if the application meets the work-sharing under the GMWSI. If accepted, the applicant may initiate the process per the consortium’s operational procedure and ultimately follow any national steps for the final decision All timelines/days are based on calendar days. If a milestone falls on a weekend or a national holiday, the milestone is the preceding business day. Please note that the following time frames are target time frames and may be adjusted depending on the complexity of the application. 1. Pre-submission meeting/teleconference (minimum 2 months in advance) - Once the participating agencies receive an EoI form, they will work together to discuss the application, its suitability for inclusion in the work-sharing initiative, the RRA and CRAs, and next steps. A pre-submission meeting/teleconference between the applicant and their local Access agency, or all participating agencies if possible (may not be granted due to operational and resource challenges), is strongly recommended. This meeting is used to discuss the technical aspects of the submission, and to confirm the logistics and expectations related to requirements, timelines for assessment and the process. The meeting also gives agencies a chance to respond to any additional questions the applicant may have. The teleconference should take place at least 2 months before the agreed-upon submission date of the application. The applicant must follow the usual procedures of their local agency when requesting a pre-submission meeting. The applicant will be asked to provide their questions at least 2 weeks before the pre-submission teleconference. Within 2 weeks of this teleconference, the applicant must provide a record of the meeting, summarizing the points that have been agreed to. 2. Submitting application (less than 15 days) - Applications should be submitted to each participating agency at the same time or as agreed with the participating agencies. The process begins as soon as all agencies have received the applications. This is “Day -15” of the process. If applicable, the Active Substance Master File/Drug Master File must be submitted to each participating agency before the application is filed, with the appropriate local forms. 3. Accepting application (15 days) - Once the participating agencies receive the application, the RRA and CRAs screen and validate the technical and administrative information. They check that their national legislation and data requirements (for example, application forms, user fees) have been met and that the application can be accepted for assessment. The RRA and CRAs then inform the applicant if their application has been accepted for assessment. If accepted, the applicant is also given a summary of the target timeframes for each step in the process. The day of acceptance of the application for assessment by the RRA is “Day 0” of the process. The CRAs will make efforts to accept the application on the same day as the RRA. 4. Round 1 assessment - (i) Initial assessment by the RRA (60 days) - The RRA evaluates Modules 2 to 5 and prepares an AR and an LoQ. At the same time, the RRA and CRAs evaluate their national Module 1 and prepare an LoQ for this module. The RRA then shares the AR and LOQ on Modules 2 to 5 with the CRAs. While a consolidated LoQ is the preferred option, the RRA may instead send rolling questions to the local applicant to seek clarification during the assessment process. If applicable, the responses to these clarification questions have a short timeframe (for example, 5 days). The RRA then shares these responses with the CRAs. (ii) Peer review by CRAs (25 days) - As part of the peer review process, the CRAs: • conduct a peer review of the AR and LoQ • consult the modules (as needed) • share comments and additional questions on Modules 2 to 5 with the RRA. (iii) Finalising ARs and LoQs (5 days) - The RRA and CRAs discuss the LoQ and any additional questions. The RRA prepares the consolidated LoQ on Modules 2 to 5. The RRA and each CRA forward the consolidated LoQ, as well as their questions on Module 1 (includes questions on product information and labelling), to their local applicant. 5. Round 2 assessment - (i) Assessing responses to LoQ (30 days) - The RRA prepares an AR of the responses on the consolidated LoQ for Modules 2 to 5 and shares it with the CRAs. At the same time, the RRA and CRAs prepare an AR of the responses to their respective country-specific questions on Module 1. (ii) Peer review by CRAs (15 days) - The CRAs conduct a peer review of the AR of the responses to Modules 2 to 5 and provide feedback. If necessary, the RRA prepares an additional LoQ, which each agency sends to the local applicant. The 15-day timeframe includes the time for peer review and for any coordination between the RRA and the CRAs. (iii) Finalising ARs and additional LoQ (5 days) - If an additional LoQ (in general, this corresponds to the preliminary decision in Switzerland) is not necessary, each agency makes a final decision. The agencies also undertake the necessary administrative steps to finalise the process for their country. 6. Round 3 assessment (if applicable) - (i) Assessing responses to the additional LoQ (15 days) - The RRA prepares an AR of the responses to the additional LoQ following the process described for round 2. (ii) Peer review of responses by the CRAs, finalising the ARs and additional LoQ (if applicable) (5 days) - The CRAs conduct a peer review of the responses and provide feedback in order for the RRA to finalise the AR. 7. National steps - Each agency makes a final decision (or seeks further clarification on issues separately before making a final decision) and undertakes the necessary administrative steps to finalise the process nationally. Depending on each agency’s assessment outcome, an authorisation letter or additional questions is issued. These communications may not necessarily happen at the same time. Total maximum elapsed timeframe from when the application is accepted (day 0) to the start of the national steps: 170 to 200 calendar days (including the applicant’s response time and if only 1 list of questions is required); or 205 to 235 calendar days (if an additional list of questions is required).