National Medicines Regulatory Authority

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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Clarifications have been issued regarding the display of "NMRA Registered Product" and MRP on commercial packs, including requirements for products already bearing the approved MRP and the use of peelable or non-peelable labels. Please read the full notice for details.
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Click Here : Notice on Labelling Requirement - Amendment 2
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NMRA සදහා ගෙවීම් කටයුතු GovPay හරහා සිදු කිරීම

ඖෂධ අංශයේ සහවිලවුන් නියාමන අංශයේ අයදුම්කරුවන් වෙත

ඔබ විසින් NMRA වෙත සිදුකරනු ලබන ගෙවීම් කටයුතු  2026.06.15 දින සිට GovPay හරහා සිදුකල හැකි බව දන්වමි. ආරම්භයේදීපහත සදහන් අංශ වලට අදාළ කාණ්ඩ (categories) වලට පමණක් GovPay හරහා ගෙවිය හැකි බව දන්වා සිටිමු. අනෙකුත්අංශවලට අදාලව ඉදිරියේදී දැනුම් දෙන බව දන්වා සිටිමු.

1.     ඖෂධ (Pharmacy) අංශයට අදාල ගෙවීමේ  කටයුතු,

2.   විලවුන් (Cosmetic) අංශයට අදාල ගෙවීමේ කටයුතු,

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එසේම , ඔබවිසින් GovPayslip පත පිරවීමේදී පහත සදහන් කරුණු සදහාවිශේෂ සැලකිල්ලක් දක්වන ලෙස දන්වා සිටිමු.

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• Reference No. / Company Name ක්ෂේත්රයේ, අයදුම්කරුවන්තම සමාගමේ නම පමණක් ඇතුළත් කළ යුතුය.
• Reason for Payment ක්ෂේත්රයේ, අදාළගොනු අංකය (FileNumber) ඇතුළත් කළ යුතුය.
• Processing fee සදහා ගෙවීම් සිදු කිරීමේදී (ගොනු අංකයක් නොමැති නම්), සමාගම්නාම (CompanyName) ක්ෂේත්රයේ සහ  ගෙවීමට හේතුව යන ක්ෂේත්රයේ (Reason for Payment)එකම සමාගම් නාමය ඇතුළත්කල යුතුය.

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‍GovPay வழியாகNMRA-க்குபணம் செலுத்துதல்

மருந்தகம் மற்றும் அழகுசாதனப் பொருட்கள் ஒழுங்குமுறைத்துறைகளில் உள்ள

விண்ணப்பதாரர்கள்

15.06.2026 முதல்NMRA-க்குGovPayவழியாகபணம் செலுத்தலாம் என்பதைத் தயவுசெய்து கவனிக்கவும். ஆரம்ப கட்டத்தில்,பின்வரும்பிரிவுகளுக்கு மட்டுமே GovPay வழியாகபணம் செலுத்தும் வசதி உள்ளது. பிற துறைகள் தொடர்பான கொடுப்பனவுகளுக்கு GovPayவசதிகிடைப்பது குறித்து பின்னர் அறிவிக்கப்படும்.

1.மருந்தகம்தொடர்பான கொடுப்பனவுகள்

2.அழகுசாதனத்துறை தொடர்பான கொடுப்பனவுகள்

மேலும், GovPay கட்டணச்சீட்டைப் பூர்த்தி செய்யும் போது, ​​பின்வரும்

அறிவுறுத்தல்களுக்குச் சிறப்பு கவனம் செலுத்தவும்:

• குறிப்புஎண் / நிறுவனத்தின் பெயர் என்ற இடத்தில், விண்ணப்பதாரர்கள்தங்கள் நிறுவனத்தின்பெயரை மட்டுமே உள்ளிட வேண்டும்.
• பணம்செலுத்துவதற்கான காரணம் என்ற இடத்தில், விண்ணப்பதாரர்கள் தொடர்புடையகோப்பு எண்ணை உள்ளிட வேண்டும்.
• கட்டணம்செயலாக்கக் கட்டணத்திற்காக செலுத்தப்பட்டால் (கோப்பு எண் இல்லை எனில்),நிறுவனத்தின்பெயர் மற்றும் பணம் செலுத்துவதற்கான காரணம் ஆகிய இரண்டு இடங்களிலும் ஒரேநிறுவனத்தின் பெயரை உள்ளிடவும்.

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Dr. W.K.C. Prabhath Werawatte

Chief Executive Officer

National Medicine Regulatory Authority  (NMRA)

Click Here : Paymentsto NMRA via GovPay

All Marketing Authorization Holders of medicines are hereby informed that two copies of the acknowledgement forms should be attached to all variation applications submitted.

For major (MaV) and minor (MiV1)variation applications, the acknowledgement will be completed by the receiving officer at the acceptance point after payment of the relevant fee.

For minor variations for notifications (MaV2), the reviewing assessor will complete the acknowledgement form and indicate whether the notification is accepted, not accepted, or whether additional information is required. After review, the completed acknowledgement will be forwarded to the acceptance point.

For major and minor variation applications, the decision will be communicated to the applicant through an evaluation form.

For minor variations for notification, no separate approval letter will be issued. The completed acknowledgement form, indicating acceptance/non-acceptance of the notification, will be serving as the official confirmation.

• Acknowledgement of application for variation of a medicine

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-   All Marketing Authorization Holders of medicines are hereby informed that Schedule I application form (APPLICATION FOR GRANT / RENEWAL OF ACERTIFICATE OF REGISTRATION OF A MEDICINE BY A LOCAL MANUFACTURER /ANAUTHORIZED IMPORTER) shall be submitted together with every variation application with immediate effect. Please note that applications submitted without Schedule I will not be accepted.

-  All the applications shouldbe submitted with the complete index to facilitate the evaluation process.