The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications.

Background

In October 2011, regulatory authorities from Australia, Brazil, Canada, the European Union (EU), South Korea, Singapore and the United States, along with representatives from the World Health Organization (WHO), met in Ottawa to discuss the “increasingly demanding review of generic drug applications.” During the meeting, the regulators highlighted some positive factors in favor of collaborating on generic drug review.

The problem, as described in an article appearing in WHO Drug Information Vol. 28 No. 1, is that the increased volume and sophistication of generic drug applications puts “significant pressure” on regulatory authorities. The IGDRP, which includes members from more than a dozen countries, aims to reduce the burden of regulatory reviews by sharing information and insights on the safety, efficacy and quality of medicines under review.

Launching the Pilot

The participating regulators agreed to a mission, goal, objectives and scope of the pilot during their second meeting in April 2012. The objectives of the program are:

• faster review and greater availability of generics
• more efficient use of resources through mutual reliance and work-sharing
• strengthen review process and international regulatory oversight while reducing regulatory burden
• promote adoption of modern, science and risk-based approaches
• rapid exchange of safety and quality information on marketed products
• enhance development of human resources

Put simply, the IGDRP will work to improve participating regulators’ ability to assess generic drugs by enabling them to reduce the duplication of effort and share information and expertise.

First Phase

The first phase of the IGDRP will include representation from the EU, Australia, Canada, Chinese Taipei and Switzerland. Sponsors have previously been asked to submit expression of interest forms to participate in the pilot program. Applications for 10 generic medicines will be used by the regulators as they develop work- and information-sharing procedures.

The remaining members, Brazil, China, Japan, South Korea, Mexico, New Zealand, Russia, Singapore and South Africa, may participate in the program at a later time.

Models for Shared Assessments

The IGDRP is modeled after the EU’s decentralized procedure where drugs are assessed on a state level rather than centrally at the EMA. In the EU’s decentralized procedure, the product sponsor submits its application to a Reference Member State (RMS), which will in turn share its assessment and other materials to the other Concerned Member States (CMS).

While the IGDRP is modeled after the decentralized procedure, it will consider generic applications using either the EU’s decentralized or centralized procedures.

A schematic of how the pilot will work is included in an expression of interest document released in July 2014. The schematic shows a company submitting an application to the EU and one or more third-party regulators simultaneously. The agencies would then “conduct separate but synchronized” assessments of the product, with outputs from the EU being shared with the third-party regulator before a final assessment is shared. Finally, depending on the outcome of the final assessment report, the regulators would grant a marketing authorization to the product.

EMA Press Release