Articles & Insights
Focused articles for pharmaceutical and healthcare manufacturers evaluating registration, local representation, import, distribution and long-term market access in Malaysia.
NPRA's 2025 list of the 50 medicines with the most special approval (Ubat Kelulusan Khas) applications, in English - with the 2024 comparison and a Malaysian registry check for every line.
Read articleThe 5-year validity and the renewal window that closes at expiry, variations before implementation, pharmacovigilance, recalls and shortage notifications - the compliance calendar every Malaysian registration holder owns.
Read articleHow a foreign manufacturer picks a Malaysian distributor - licences, GDP, cold chain, channel fit - and the eight areas the distribution agreement must settle, starting with who holds the registration.
Read articleNeither NMPA nor CDSCO is an NPRA reference agency. What WHO prequalification, EMA/FDA approvals and EU GMP or FDA site status change, what the dossier needs, and the local MAH requirement.
Read articleThree ways to hold a Malaysian registration - distributor, subsidiary, independent MAH - compared on the criteria that decide it, plus the eight contract questions to answer before signing.
Read articleImport and Wholesaler's Licences (RM 500, valid to 31 December), GDP as a licensing condition, NPRA's cold chain inspections - and the flow a shipment follows from port to pharmacy.
Read articleMandatory since 1 July 2026: at least six months' advance notice, a public database that names the holder, and warning letters with two-day deadlines. What the registration holder is now responsible for.
Read articleMove your Malaysian registration to a new holder without re-registering: NPRA's Change of Product Registration Holder (COH) - timeline, validity rule, documents and fees.
Read articleWhat a Marketing Authorisation Holder (MAH) does in Malaysia, why a foreign manufacturer needs a local one, and the three ways to have an MAH compared.
Read articleWhat it takes to import and distribute pharmaceuticals in Malaysia in 2026 - the licences involved, Good Distribution Practice (GDP), and why registration and a local holder come first.
Read articleThe main pharmaceutical distributors and wholesalers in Malaysia in 2026, how they differ from a Marketing Authorisation Holder (MAH), and how a foreign manufacturer should choose the right local partner.
Read articleHow drug registration in Malaysia works in 2026: who can hold the registration (MAH), the NPRA routes and timelines, dossier requirements and the practical steps.
Read articleWhy Malaysia is an underrated 2026 entry point for EU pharma: PIC/S regulator, ~60-day FDA/EMA fast-track, ASEAN base and how to enter without giving up control.
Read articleLetting your distributor hold your NPRA registration is a real lock-in risk. What the rules actually say about the change of MAH, and how to keep control by contract.
Read articleNPRA's new Facilitated Registration Pathway pilot (from 2 May 2026) gives FDA/EMA-approved drugs a 60-working-day target. Who qualifies, the sameness rules and the 3-month window.
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