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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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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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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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Extension of the Submission Deadline for the Foreign Medicine Manufacturing Site Renewal Application

To All Market Authorization Holders of Medicines,

Please be informed that the implementation of the renewal process for overseas Pharmaceutical manufacturing site approvals by the National Medicines Regulatory Authority (NMRA) has been extended until1 January 2027.

Initially, Manufacturing sites approved before the year 2010 will be required to submit applications for renewal.

NMRA may conduct an onsite GMP inspection of the manufacturing site, where deemed necessary, as part of the renewal process,irrespective of whether the site has previously been inspected by NMRA or an NMRA-recognized reference regulatory authority.

Please note that from 1^stJanuary 2027, if the renewal application of a foreign manufacturing site has not been submitted, the following regulatory actions will apply:

·        Renewal of the registration of products manufactured at that site will not be granted.

·        New product applications, including applications for Sample Import Licences and Product Registration,for products manufactured at that site will not be accepted.

This extension is granted to provide Market Authorization Holders with additional time to prepare and submit the required documentation for the renewal of foreign Pharmaceutical manufacturing site approvals.

Updated Application form and the checklist for accepting renewal dossier submission are attached herewith.

Click here :

• ‍Checklist for Accepting Application for Renewal of an Overseas Manufacturer of Medicines
• ‍Application for Renewal of an Overseas Manufacturer of Medicines

CEO/NMRA

Notice to all Authorized Local Agents,

Average US Dollar Rate July-2026  for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that the USD rate considered for the month of July-2026 for processing price details of medicines/medical devices is 333.12.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

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• The statement "Prescription Only" should be included on the Product Label and Patient Information Leaflet (PIL)
• The statement "Dosage as directed by the physician" should be included in the PIL
• The Patient Information Leaflet (PIL) should be revised in accordance with the applicable Summary of Product Characteristics (SmPC)
• Prescribers' information should be included in the PIL as a separate section.