The Medicines Regulatory Division (MRD) of the National Medicines Regulatory Authority (NMRA) has revised the "Document Submission Form to Get Initial Decision for New Molecular Entity from Medicines Evaluation Committee (MEC)". The revised document is available under the "Application Forms" section of the Medicines Regulatory Division on the NMRA website.

Accordingly, with effect from 09 July 2026, all applicants and Market Authorization Holders seeking an initial decision from the Medicines Evaluation Committee (MEC) for New Chemical Entity (NCE) applications are required to use the revised Document Submission Form to Get Initial Decision for New Molecular Entity from Medicines Evaluation Committee (MEC).
Applications shall be submitted together with a Letter of Authorization, a copy of the manufacturer's company profile, or a valid Good Manufacturing Practice (GMP) Certificate or GMP Inspection Report, as applicable, in accordance with the amended document.

Click Here : Revised Document Submission Form for New Molecular Entity (NME) Applications

Chief Executive Officer
National Medicines Regulatory Authority

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