Snapshot

The HSA-NPRA Generic Medicines Work Sharing Initiative pathway has been developed by the of Malaysia.

This pathway can be used where generic medicines.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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

All applicants who had submitted Expressions of Interest (EOI) will be notified by the Agencies if their application is shortlisted for the pilot. For shortlisted applications, a tele-conference meeting between the applicant and both agencies will be held to address any concerns/ queries the applicant has. Differences, if any, in the dossiers to be submitted to both Agencies (as declared in the EOI form) should also be highlighted to the Agencies during the teleconference. The applicant will also be required to confirm that the minimum submission requirements can be met. *Note: Tele-conference is to be conducted at least 2 months before the planned submission date. After the tele-conference, the applicant will be notified if their application is confirmed for participation in the pilot, and to proceed with submission. The application should be submitted to both Agencies simultaneously on the same day. Once the application is accepted for evaluation by both Agencies, the review will take place simultaneously. It can be expected that any queries related to the technical dossier will be similar or the same. This means that the applicant will most likely not be required to address two separate sets of queries. While it is anticipated that the work sharing review will arrive at the same assessment, the individual Agency will make its own independent decision. The processing time of the application will not be any worse-off than the standard timelines of the respective Agencies. The process from applicant submitting EOI to the Agencies up to Agencies performing national steps towards decision (or issuance of additional LoQ (if applicable)) will take 285 working days.