Since 1 July 2026 Malaysian registration holders must report medicine shortages and discontinuations to NPRA in advance, into a database that makes coming shortages visible. RHMI works both sides of that visibility: for Malaysian demand, we identify manufacturers with stock or capacity to cover a shortage; for foreign manufacturers, a verified shortage can be a fast, concrete entry point into the Malaysian market - handled within the regulatory framework that applies to shortage mitigation.
A note on terms: NPRA officially calls the holder the Product Registration Holder (PRH). Throughout RHMI's guides we use the equivalent international term, Marketing Authorisation Holder (MAH) - they mean the same party.
Why shortages are now visible - and actionable
Malaysia's mandatory shortage reporting regime, in force since 1 July 2026, requires holders to report current and anticipated shortages and discontinuations at least six months in advance - or as soon as practicable where six months is impossible. That changes the game: shortages stop being rumours and become documented, dated market signals. A manufacturer with the right product and available stock can respond to a real, verified need - not a guess. Malaysia's shortage reporting rules, explained.
What RHMI does
- Monitoring. We track reported shortages and discontinuations relevant to our partners' portfolios.
- Matching. When a shortage matches a manufacturer we work with - or a manufacturer approaches us with available stock - we assess whether the product can lawfully cover the gap and on what timeline.
- Regulatory mechanics. Shortage situations have specific, regulator-controlled mitigation routes: importing a registered product with a different country label, requesting from NPRA a priority review for a product already under evaluation, or - in defined cases and only with written authorisation - import of an unregistered product under Regulation 15(6). Nothing is supplied until the relevant authorisation is granted. This is regulated territory, not a grey market.
- The longer game. A shortage response is often the fastest credible way for a new manufacturer to enter Malaysia: a first supply with a documented need behind it, and a registration strategy that follows.
For manufacturers with stock or capacity
If you produce medicines with strong quality standing - especially with recognised-agency approvals or WHO prequalification - and have stock or free capacity, tell us what you make. When a matching shortage is reported, speed decides who supplies it - and a manufacturer whose products and quality standing we already know is assessed first. Contact us.
For Malaysian buyers facing a shortage
If you are on the demand side - a hospital, pharmacy group, wholesaler or procurement team in Malaysia that cannot source a medicine - tell us the product, dosage form, strength, the quantity you need and how urgent it is. We check whether a manufacturer we know can lawfully cover the gap, and which regulator-controlled route applies to your case. Where a special approval from the authorities is required, we assess that first - nothing is supplied without it. Submit a medicine requirement →
Frequently asked questions
Can an unregistered product be supplied during a shortage?
Only through the regulator-controlled mitigation routes: in defined cases NPRA/MOH can authorise, in writing, the import of a product not registered in Malaysia (Regulation 15(6)), or of a registered product carrying another market's label. Nothing is supplied until that authorisation is granted. Whether a specific product qualifies is exactly what we assess - case by case.
How do you know about shortages?
Since 1 July 2026 registration holders must report current and anticipated shortages and discontinuations to NPRA in advance (at least six months, or as soon as practicable). We monitor these signals systematically, alongside our own market contacts.
We are a manufacturer with free capacity. What do you need from us?
Your product list with formulations and strengths, your quality standing (GMP certification, existing approvals), and realistic lead times. That is enough to match you against reported shortages.
Is this RHMI's main business?
Our core is regulatory: registration, the independent MAH role, import and distribution. Shortage response is a specific capability on top of that core - and often the fastest first step into the market for a new manufacturer.
You might also find useful
- Malaysia's Medicine Shortage Reporting Rules (2026): What Every MAH Must Now Do
- Importing and Distributing Pharmaceuticals in Malaysia: Licences and GDP
- Marketing Authorisation Holder (MAH) in Malaysia: What It Is and How to Appoint One
- Editorial note: This page describes RHMI's shortage response service. Regulatory timelines, fees and eligibility are administrative details that change; we confirm them against NPRA's current guidance in every engagement. Last reviewed: 1 September 2026.