JFDA Bioequivalence Guidelines & ICH M13 New Guidelines

On the 1st of December 2025, we assembled to review the latest updates to the JFDA Bioequivalence Guidelines and the new ICH M13 Guidelines.

 

We extend our sincere appreciation to our colleagues at the JFDA for presenting the key updates on the new requirements and the implementation of M13A, and for their continued dedication under the leadership of H.E. Dr. Rana Obeidat, Director General of the JFDA.

Our gratitude is also extended to the esteemed speakers:

  • Shatha Quraan, Head of the Chemical Products Registration Department, JFDA
  • Eman Awamleh, Head of Scientific Advice Unit, JFDA
  • Enas Hajjeh, Head of Bioequivalence Division, JFDA
  • Bayan Hiasat, Regulatory Affairs Specialist, JFDA

 

We greatly appreciate their insightful presentations and valuable contributions, which were essential to the success of the workshop.

 

The event was further enriched by the participation of distinguished professionals from the JFDA, respected members of the DOA, and representatives from various multinational and local pharmaceutical companies and distributors. Their active engagement and thoughtful discussions significantly enhanced the quality and outcomes of this important gathering.

Author: Diala AbuShahin

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