Pilot Program to Coordinate Generic Approvals Worldwide Launched in Europe
Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders.
According to the European Medicines Agency, scientific assessments of products generated as part of the EU’s generic drug approval process will be available upon a manufacturer’s request to regulators in Australia, Canada, Taiwan and Switzerland. The EU will share this information in real time, a process that should allow drugs to be authorized in different territories at roughly the same time, the agency said.
Additional countries that may join the pilot program later include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa, it added.
Generics firms may choose to participate in the program, according to the EMA’s recent expression of interest seeking participants. Applications are due by Sept. 26.
Criteria for participating include synchronizing filings of applications for the same product in the EU and at least one of the participating jurisdictions, and ensuring any minor differences in the product intended for authorization in the EU and corresponding jurisdiction would not affect the safety, efficacy or quality of the product.
The data-sharing program is part of the broader International Generic Drug Regulators Pilot, which launched in 2012. The three-year pilot seeks to address international generics challenges, such as the time and expense that is required to apply for approvals in multiple countries that all have their own requirements and regulatory schemes.
The pilot aims to streamline the approval process and cut down on approval costs, which may ultimately translate to cheaper prices and faster paths to market.
The European Generic Medicines Association was not available for comment. — Bryan Koenig
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.