Public Consultation Announcement – Draft Guideline on the  Review of Bioequivalence (BE) studies and CDR

The National Medicines Regulatory Authority  (NMRA) hereby announces the opening of the public consultation period for the  Draft Guideline on the Review of Bioequivalence (BE) studies and CDR developed to strengthen regulatory evaluation processes and ensure the  quality, safety, and efficacy of medicinal products registered in Sri Lanka.

Stakeholders, including pharmaceutical  manufacturers, importers, marketing authorization holders, healthcare  professionals, academic experts, and other interested parties are invited to  review the draft guideline and submit their comments.
 
Consultation Period
26 June 2026 to 10 July 2026
 
Submission of Comments
All comments, suggestions, and technical  inputs should be submitted via email to:
 
 aa24@nmra.gov.lk
 qms@nmra.gov.lk

Please ensure that submissions are clear,  evidence‑based, and referenced where applicable. Stakeholder feedback will be reviewed by the NMRA to finalize the guideline.

Click Here :  Draft Guideline on the  Review of Bioequivalence (BE) studies and CDR

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