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Respond to each query and pay each fee notice below. While any of these are open, NPRA pauses the clock on your applications, so take care of them first.
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MAL26050018AJustify proposed 24-month shelf-life from 18 months real-time + 6 months accelerated6 d overdue
HSHu Suk KwanQuery
Per ICH Q1E §2.5, extrapolation beyond available real-time data requires statistical justification including Arrhenius modelling on the accelerated profile. The submitted dossier (Module 3.2.P.8.3, p.142) does not present the extrapolation calculation. Please provide.
Due 23 May 2026Carbalox 200mg
MAL26050018AProvide comparator-lot CoA and BE study addendum for the 200mg strength1 d overdue
HSHu Suk KwanQuery
The submitted BE study used a 100mg-strength comparator extrapolated to 200mg via dose-proportionality. Please submit a 200mg-strength comparator-lot CoA and confirm in-vitro dissolution profile bracketing.
Due 28 May 2026Carbalox 200mg
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| Submission | Activity | Type / change | Stage | SLA |
|---|---|---|---|---|
AMOX Amoxicillin 250mg/5ml Powder for SuspensionREG/2025/00876 | New product | New registrationGeneric · full evaluation | +32 dSLA | |
REG Metfornaga 1000mg prolonged-release tabletREG/2026/00103 | New product | New registrationGeneric · abridged | pausedwith you | |
METF Metformin XR 750mg Prolonged-release TabletREG/2026/00203 | New product | New registrationGeneric · abridged | +168 dSLA | |
INSG Insulin Glargine 100u/ml InjectionREG/2026/00231 | New product | New registrationBiologic · biosimilar | +312 dSLA | |
REG Rivanaga 20mg film-coated tabletREG/2026/00418 | New product | New registrationGeneric · abridged | +352 dSLA | |
AMLO Cardiplo 5mg TabletVAR/2026/00308 | Maintain | Variation · Type IBAdd alternate API manufacturing site | +257 dSLA | |
AMLO Cardiplo 5mg TabletCOH/2026/00029 | Maintain | Change of holderChange of registration holder | +124 dSLA | |
CETI Cetiriz 10mg Film-coated TabletREN/2026/00156 | Maintain | RenewalRenewal | +163 dSLA | |
AMLO Cardiplo 5mg TabletVAR/2026/00188 | Maintain | Variation · Type IIExtension of shelf-life from 24 to 36 months | +176 dSLA | |
CETI Cetiriz 10mg Film-coated TabletREN/2026/00112 | Maintain | RenewalRenewal · 5-year | +76 dSLA | |
REG Nuvolimab 100mg/10ml concentrate for infusionREG/2025/01024 | New product | New registrationBiologic · monoclonal antibody | +190 dSLA |
Your portfolio
Everything you do with NPRA
Your work grouped by what you want to achieve rather than by which form it lives in. Each card shows where you stand and the next step to take.
01
Account & certificates
Your company profile, the people authorised to act for it, and the digital certificates that sign every submission.
3Active users
3Certificates
1Expiring
02
New products
Registrations and cosmetic notifications you are taking through NPRA evaluation.
6Under review
3Drafts
3Approved
03
Cosmetics
Notify cosmetic products under the ASEAN Cosmetic Directive, keep them current, and pull Free-Sale certificates.
11Notified
1In review
0Renew soon
04
Maintain
Variations, renewals and transfers on the products you already hold a registration for.
3Registered
5In progress
2Renewals due
05
Compliance
Establishment licences, GMP/GDP inspections and good-practice certificates for your sites.
2Licences
1Expiring
0Inspections
06
Export certificates
CPP and Free-Sale certificates that let you export your registered products.
1Requests
3Eligible products
07
Payment
Invoices, payments and downloadable receipts for everything you lodge.
8Outstanding
2Paid
0Notices
08
Help
Questions, system issues and complaints — routed to the NPRA helpdesk with a reference you can track.
0Open tickets
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