Work-sharing

In the context of pharmaceutical and regulatory affairs, work-sharing refers to a specific process whereby a marketing authorization holder (MAH) submits a single application for a variation that impacts multiple marketing authorizations for the same medicinal product. This collaborative approach streamlines the regulatory process, as it allows the MAH to make changes to several marketing authorizations simultaneously, rather than submitting separate applications for each authorization.

The need for work-sharing arises when a medicinal product has been approved and marketed in multiple countries or regions, each with its regulatory authority responsible for granting marketing authorizations. Over time, there may be reasons for the MAH to introduce changes to the product, such as updating labeling, manufacturing processes, or safety information. In the traditional approach, the MAH would have to submit individual variation applications to each regulatory authority where the product is marketed, leading to duplicated efforts and potentially delayed approvals.

With work-sharing, the MAH can compile all the required changes into a single variation application, which is then submitted to a lead regulatory authority. The lead authority coordinates the assessment process and works in collaboration with other concerned regulatory authorities to evaluate the proposed changes and their potential impact on the product’s safety, efficacy, and quality. Once a consensus is reached, all involved regulatory authorities update their respective marketing authorizations accordingly, reflecting the approved changes.