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The Pharmaceutical and Medical Devices Agency (PMDA), Japan’s Regulatory authority responsible for overseeing pharmaceuticals and medical devices, has introduced a groundbreaking initiative called the PRIME System to help expedite the review and approval process for innovative therapies.

The PRIME System aims to ensure that promising new medicines reach patients faster while maintaining the highest standards of safety and efficacy.

Under the PRIME System, designated products are granted priority review, which in turn enables an efficient and focused evaluation process. This accelerated assessment process enables the PMDA to provide valuable feedback to sponsors early on, thereby facilitating the optimization of development plans and ensuring alignment with Regulatory requirements.

Eligibility Criteria for PRIME Designation

To qualify for PRIME designation, a product must meet certain specific criteria, which are elucidated below:

  • Addressing unmet medical needs or significantly improving existing therapies.
  • Utilizing innovative technologies or approaches.
  • Possessing a robust clinical development plan.
  • Demonstrating a clear value proposition for patients.

Benefits of PRIME Qualification

Companies that secure PRIME designation for their products get several benefits. The three (03) key advantages are as follows:

  • Priority Review: The PMDA expedites the review process for PRIME-designated products, potentially reducing the time to market by several months.
  • Early Engagement: The PMDA proactively engages with PRIME-designated sponsors, providing them with regular feedback and guidance throughout the development process.
  • Enhanced Communication: The PMDA maintains open communication with PRIME-designated sponsors, ensuring clarity in mutual expectations, facilitating seamless coordination between both ends and minimizing potential delays.

Today, the PRIME System has emerged as a key driver of medical innovation in Japan. By streamlining the Regulatory process for promising therapies, the PMDA is paving the way for the development and availability of new treatments that address unmet medical needs and improve patient outcomes. To learn more about Japan’s PRIME System, get in touch with our experts today.