The National Medicines Regulatory Authority (NMRA) hereby informs all local manufacturers that the current two-stage process for the classification and formulation approval of borderline products will be streamlined into a single-stage application process.

Accordingly, applicants should submit all documents required for formulation approval, except the Preliminary Evaluation Report (Classification Report), together with the application for classification.

Applicants are further informed that the applicable Formulation Approval Fee shall be paid at the time of submission of the Classification Application to the Borderline Products Regulatory Division. Applications submitted without the relevant payment will not be accepted for processing.

All applicants are required to comply with the above requirement. The cooperation of all applicants in this regard is appreciated.

Note: Applications, for which the classification application has already been submitted shall proceed under the existing procedure, i.e., by submitting the Formulation Approval Application separately, along with the Preliminary Evaluation Report (Classification Report).

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