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Philippines Seeks Feedback On Plan To Recognize BE Studies Under ASEAN Deal

 
• By Vibha Sharma

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers. 

flags of ASEAN an abbreviation for the Association of Southeast Asian Nations,is a political and economic union of 10 states in Southeast Asia
The MRA Can Help Stabilize The Supply Of Generic Medicines In ASEAN Countries • Source: Shutterstock

The Philippines Food and Drug Administration is inviting stakeholder feedback on its plans to implement the Association of Southeast Asian Nations’ mutual recognition agreement (MRA) for bioequivalence (BE) study reports that aims to reduce trade barriers for generic medicines in the ASEAN region.

Key Takeaways

  • The Philippines FDA has issued a draft administrative order to officially adopt and implement the ASEAN mutual recognition agreement for BE study reports of generic medicinal products.

  • The MRA aims to facilitate the movement of generic products in the ASEAN region

In its consultation document, the FDA clarifies that while it would accept the BE study reports from ASEAN-listed BE centers under the MRA, this acceptance should not be interpreted as an approval of the application for product registration

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