Access Generic Medicines Work Sharing Initiative

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the Generic Medicines Work-Sharing Initiative (GMWSI) within the Access Consortium, which includes regulatory authorities from Australia, Canada, Singapore, and Switzerland. This initiative aims to streamline the approval process for generic drugs by allowing multiple international agencies to share the assessment workload. To participate, applicants must submit an Expression of Interest (EOI) form three to six months before their target submission date. The process requires filing identical technical dossiers (Modules 2-5) to all participating regulators, though country-specific administrative information (Module 1) remains mandatory for each jurisdiction. Under this framework, a lead Reference Regulatory Agency conducts the primary review, while other participating bodies perform peer reviews and provide supplementary comments. This collaboration results in a consolidated list of questions for the applicant. Despite the shared assessment, each national regulator maintains sovereign authority to make independent decisions regarding marketing authorization based on their specific legal requirements. Applicants are responsible for paying standard national fees to each agency. The guidance emphasizes that while global consistency is preferred, any differences in the data provided to different countries must be clearly identified and justified during the initial application phase.