The NPRA UKK list 2025 is circular NPRA.600-1/9/12(32), dated 16 April 2026 and published on NPRA's site on 20 April 2026. It lists the 50 products with the most Ubat Kelulusan Khas (UKK, special approval) applications in Malaysia in 2025 - products that were either not registered, or registered but not marketed. Amitriptyline 25 mg and 10 mg tablets lead it, with 1,260 applications between them. The English table below adds RHMI's own comparison with the 2024 list (38 of 50 lines repeat) and a registry check as of 1 October 2026 (33 lines with no matching registration).
What the UKK list is
Malaysian law requires medicines to be registered with the Drug Control Authority before they are sold or supplied. For patients with life-threatening conditions, Regulation 15(6) of the Control of Drugs and Cosmetics Regulations 1984 allows an exemption: a health facility applies for Ubat Kelulusan Khas (UKK) - "special approval medicine" - and imports or obtains an unregistered product for that treatment. These applications are assessed by the Formulary Management Branch of the Ministry of Health's Pharmacy Practice and Development Division (BAPF), and they come from both Ministry of Health and non-Ministry, including private, facilities.
Once a year NPRA counts those applications and publishes the 50 products with the highest number. The circular describes the supply behind them in two situations: the product is not registered in Malaysia, or a registered product exists but is not marketed. It is addressed to all registration applicants and the relevant industry associations, and states its purpose plainly: in line with the Ministry's policy of prioritising registered products, NPRA shares the list with registration holders and industry associations so that these products can be registered and then marketed for the patients who need them - provided the applications are complete and meet the Drug Control Authority's requirements.
Five things the 2025 list tells a manufacturer
- Requests recur. 38 of the 50 lines also appeared on the 2024 list (on our matching, which counts the testosterone line although the 2024 list did not name the ester). Applications in two consecutive lists point to a recurring need, not a one-off.
- 33 lines have no matching registration. On our check against active registrations as of 1 October 2026, 33 lines had no registered product matching the listed medicine for human use - for most, no registration of the molecule at all; for a few, only combination or veterinary products. 26 of those 33 were also on the 2024 list.
- 11 lines: the molecule is registered, but not as listed. Cyclophosphamide is registered as an injection but not as the 50 mg tablet, phenobarbitone as a tablet but not as an injection, acyclovir in several forms but not as an eye ointment. The route for the missing form depends on your product and dossier, not on the existing registration.
- 6 lines have a matching active registration. In our check a matching product is registered - yet health facilities still applied for special approval in 2025. Whether it is marketed today, and why it was requested through UKK, needs separate verification.
- Several of the most requested products are long-established generics on the National Essential Medicines List. Amitriptyline (positions 1 and 2), misoprostol, testosterone enanthate, fludrocortisone and chlorpromazine are all marked NEML. Amitriptyline was not on the 2024 list and went straight to the top: 1,260 applications covering about 18 million tablets in 2025. The two amitriptyline products in the Malaysian registry share one holder.
The full 2025 list in English
Translated from Annex A (Lampiran A) of NPRA circular NPRA.600-1/9/12(32). Columns 1-6 are NPRA's data; the last two columns are our additions. Each row has its own link - click the number and the address bar holds a link straight to that line.
FUKKM - Ministry of Health Medicines Formulary. NEML - National Essential Medicines List. Registry (1 Oct 2026) - our check against active Malaysian registrations, not NPRA's classification. Download the table as CSV.
| # | Medicine (as listed by NPRA) | Applications | Quantity | FUKKM | NEML | 2024 list | Registry, 1 Oct 2026 |
|---|---|---|---|---|---|---|---|
| 1 | Amitriptyline HCl 25 mg Tablet | 857 | 14,923,095 tablets | Yes | Yes | New | Registered |
| 2 | Amitriptyline 10mg Tablet | 403 | 3,293,460 tablets | No | Yes | New | Registered |
| 3 | Melatonin 3mg Tablet/Capsule | 183 | 596,495 tablets/capsules | No | No | #2 | Not registered |
| 4 | Misoprostol 200mcg Tablet | 165 | 143,642 tablets | No | Yes | #11 | Not registered |
| 5 | Testosterone Enanthate 250mg/ml Injection | 148 | 36,838 vials/ampoules | Yes | Yes | #1* | Other form or strength |
| 6 | Acyclovir 3% Ophthalmic Ointment | 129 | 18,321 tubes | Yes | No | #3 | Other form or strength |
| 7 | Fludrocortisone Acetate 0.1 mg Tablet | 123 | 669,114 tablets | Yes | Yes | #4 | Not registered |
| 8 | Phenobarbitone Sodium 200 mg/ml Injection | 122 | 23,120 vials/ampoules | Yes | No | #5 | Other form or strength |
| 9 | Thiamine (Vitamin B1) 100mg/ml Injection, 2ml | 110 | 216,380 vials/ampoules | Yes | No | #7 | Other form or strength |
| 10 | Synthetic ACTH (Tetracosactrin Acetate) 250 mcg/ml Injection | 109 | 9,113 vials/ampoules | Yes | No | #6 | Not registered |
| 11 | BCG 80mg (Bacillus Calmette-Guérin freeze-dried intravesical preparation) | 106 | 3,488 vials/ampoules | Yes | No | New | Other form or strength |
| 12 | Cyclophosphamide 50mg Tablet | 103 | 255,442 tablets | Yes | Yes | #9 | Other form or strength |
| 13 | Hyoscine (Scopolamine) 1.5 mg Transdermal Patch | 102 | 20,617 patches | No | No | #14 | Not registered |
| 14 | Indocyanine Green 25mg powder for injection | 102 | 10,379 vials/ampoules | No | No | #18 | Not registered |
| 15 | Cholestyramine Resin 4 gram/sachet | 94 | 208,366 sachets | Yes | No | #8 | Not registered |
| 16 | Clonidine HCl 0.025 mg Tablet | 83 | 501,336 tablets | Yes | No | #24 | Other form or strength |
| 17 | Sucralfate 1 g Tablet | 82 | 321,732 tablets | Yes | No | #15 | Not registered |
| 18 | Aztreonam 1g Injection | 81 | 33,411 vials/ampoules | No | No | #19 | Not registered |
| 19 | Fruquintinib 5mg Capsule (Fruzaqla) | 79 | 22,887 capsules | No | No | New | Not registered |
| 20 | Dapsone 100 mg Tablet | 79 | 481,360 tablets | Yes | Yes | #10 | Registered |
| 21 | Chlorpromazine 25mg Tablet | 76 | 825,900 tablets | No | Yes | #20 | Registered |
| 22 | Chloral Hydrate 500mg/5ml Suspension, 500ml | 75 | 11,356 bottles | Yes | No | New | Not registered |
| 23 | Adrenaline (Epinephrine) 0.3mg Auto-Injector | 72 | 1,357 auto-injectors | No | Yes | #17 | Registered |
| 24 | Procyclidine HCl 10mg/2ml Injection | 70 | 17,800 vials/ampoules | Yes | No | #16 | Not registered |
| 25 | Levamisole 50mg Tablet | 69 | 57,217 tablets | No | No | #30 | Not registered |
| 26 | Urokinase 60,000 IU Injection | 67 | 5,962 vials/ampoules | No | No | #13 | Not registered |
| 27 | Isoprenaline HCl 0.2mg/ml Injection, 1ml | 67 | 16,195 vials/ampoules | Yes | No | #21 | Not registered |
| 28 | Diazoxide 100mg Capsule/Tablet | 65 | 86,047 tablets/capsules | No | No | #29 | Not registered |
| 29 | Diltiazem 2% Topical Gel | 65 | 9,245 tubes | No | No | #22 | Other form or strength |
| 30 | Metolazone 5 mg Tablet | 64 | 559,680 tablets | No | No | #38 | Not registered |
| 31 | Dantrolene Sodium 20mg Injection | 58 | 2,350 vials/ampoules | No | No | #27 | Not registered |
| 32 | Pentamidine isethionate 300mg Nebuliser Solution | 58 | 4,159 vials/ampoules | No | No | #40 | Other form or strength |
| 33 | Procarbazine HCl 50 mg Capsule | 58 | 68,570 capsules | Yes | Yes | #32 | Not registered |
| 34 | Flucytosine 500 mg Tablet | 57 | 107,900 tablets | Yes | Yes | #44 | Not registered |
| 35 | Rifaximin 550 mg Tablet | 56 | 225,316 tablets | No | No | #25 | Not registered |
| 36 | Oxybutynin Chloride 5 mg Tablet | 56 | 216,988 tablets | Yes | No | #34 | Not registered |
| 37 | Tizanidine HCl 4 mg Capsule/Tablet | 55 | 138,371 tablets/capsules | No | No | #31 | Not registered |
| 38 | Iodine and Potassium Iodide Solution 100ml (Lugol's Solution) | 54 | 900 bottles | Yes | Yes | #47 | Not registered |
| 39 | Lomustine 40 mg Capsule | 53 | 2,806 capsules | No | No | #43 | Not registered |
| 40 | Pyrimethamine 25mg Tablet | 52 | 123,440 tablets | No | No | #37 | Not registered |
| 41 | Sodium Bicarbonate 650mg Tablet | 51 | 1,156,136 tablets | No | Yes | #26 | Other form or strength |
| 42 | Sacituzumab Govitecan 180mg Injection (Trodelvy) | 50 | 4,620 vials/ampoules | No | No | New | Not registered |
| 43 | Lutetium-177 Tri-Chloride 200mCi Injection | 47 | 678 vials/ampoules | No | No | New | Not registered |
| 44 | Pegylated L-Asparaginase 3750 IU/5ml Injection | 47 | 1,155 vials/ampoules | No | No | New | Registered** |
| 45 | Iloprost Trometamol 50mcg/0.5ml Injection | 46 | 2,165 vials/ampoules | No | No | New | Other form or strength |
| 46 | Rasburicase 1.5mg Injection | 46 | 2,057 vials/ampoules | No | No | New | Not registered |
| 47 | Sodium Tetradecyl Sulphate 3% Injection | 46 | 4,871 vials/ampoules | Yes | No | #41 | Not registered |
| 48 | Atomoxetine HCl 10mg Capsule/Tablet | 45 | 146,100 tablets/capsules | Yes | No | New | Not registered |
| 49 | Oraltek Sublingual Immunotherapy (SLIT) 3-in-1 Dustmite Perlingual Spray | 45 | 1,898 vials/ampoules | No | No | New | Not registered |
| 50 | Papaverine HCl 50mg/2ml Injection | 45 | 8,910 vials/ampoules | No | No | #39 | Not registered |
Source: NPRA, Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2025, Annex A. Medicine names and quantities as printed by NPRA. "2024 list" shows the position on the 2024 list where the same product (molecule, form and strength) appears. Registry status from the Ministry of Health's open pharmaceutical products dataset (data.moh.gov.my, updated 1 October 2026), spot-checked in QUEST3+. *Row 5: the 2024 list reads "Testosterone 250mg/ml Injection" without naming the ester. **Row 44: matched to Oncaspar 750 U/ml, assuming 750 U/ml x 5 ml = 3,750 IU as labelled.
How to read a line before you act on it
- Match the exact product. UKK demand is for a specific form and strength. Registered hyoscine butylbromide products do not cover line 13, which is a scopolamine (hyoscine) transdermal patch - a different active substance.
- Treat it as a demand signal, not an order. The list counts applications and quantities from 2025. It commits no buyer, and registration by itself does not establish formulary listing or a purchase.
- Check who else is moving. A product can be registered between the list's publication and your decision - four from the 2024 list have been. Re-check QUEST3+ before you commit budget.
- Note the formulary columns. FUKKM and NEML show whether the item is already on the Ministry of Health formulary or the essential medicines list - useful context for public-sector use, assessed separately from registration.
- A matching registration is its own case. If the product is already registered, find out whether it is marketed and why facilities still applied for UKK before planning another application - NPRA sets specific conditions for applications covering identical products.
From UKK demand to a registered product
NPRA's own condition is the starting point: the registration application has to be complete and meet the Drug Control Authority's requirements. For a foreign manufacturer that means four practical steps.
- Confirm the match and the route. Same molecule, form and strength as the line; generic or new drug category. How drug registration in Malaysia works; for products already approved by FDA or EMA, the facilitated pathway may apply.
- Appoint a Marketing Authorisation Holder (MAH). For the standard commercial route, a foreign manufacturer appoints a Malaysian company that meets NPRA's applicant requirements as its MAH. The MAH files the application, answers NPRA's queries and carries the post-approval duties for the life of the product. What an MAH does.
- Decide who your MAH is - before you sign. If your distributor is the MAH, your product's regulatory future sits inside a sales company. An independent MAH holds the registration as its core service: your dossier stays yours, and the choice of distributor stays open. Independent MAH vs distributor as MAH.
- Plan import. After registration, product is imported and distributed by licensed companies. RHMI currently coordinates import through a licensed import partner, which acts as importer of record. Appointing RHMI as MAH does not require handing us distribution.
Whether a line is worth pursuing depends on details the table cannot show: your dossier, your price against current special-approval supply, and the size of the need behind the applications. If your dossier needs adapting to NPRA's requirements, our partners can help bring it up to standard.
How this table was built
- Transcription. NPRA published the 2025 list as a scanned PDF with no text layer. We transcribed all 50 rows (7 columns, 350 cells) from the scan and had the transcription checked independently against the images.
- 2024 comparison. Matched to the 2024 list (circular NPRA.600-1/9/12(28)) only where molecule, dosage form and strength are the same. Chloral hydrate is not counted: the 2024 line was a syrup, the 2025 line a suspension.
- Registry check. Each line was searched by active ingredient, including spelling variants, in the Ministry of Health's open dataset of approved pharmaceutical products (data.moh.gov.my, updated 1 October 2026; active registrations only), with spot checks in QUEST3+. "Not registered" means no active registration of a product matching the listed medicine for human use - the molecule may still appear in combination or veterinary products (see the notes in the CSV). "Other form or strength" means the molecule is registered, but not as listed. "Registered" means a matching product has an active registration as of 1 October 2026; it does not show whether the product is marketed.
- What it is not. The registry column is our own check at one date, not an NPRA statement, and registrations change. It is not a list of products available for supply: nothing here suggests that any medicine can be supplied without registration or special approval.
Frequently asked questions
What is UKK (ubat kelulusan khas) in Malaysia?
Ubat Kelulusan Khas (UKK), or special approval medicine, is the exemption under Regulation 15(6) of the Control of Drugs and Cosmetics Regulations 1984 that lets a health facility obtain an unregistered medicine for treating a life-threatening condition. Applications are assessed by the Ministry of Health's Pharmacy Practice and Development Division (BAPF).
What is the NPRA UKK list?
An annual NPRA circular listing the 50 unregistered, or registered but not marketed, products with the highest number of UKK applications in the previous year. The 2025 list is circular NPRA.600-1/9/12(32), dated 16 April 2026 and published on 20 April 2026.
Which medicine tops the 2025 UKK list?
Amitriptyline hydrochloride 25 mg tablets, with 857 applications, followed by amitriptyline 10 mg tablets with 403. Neither line appeared on the 2024 list.
What does "registered but not marketed" mean on the UKK list?
It is one of the two situations NPRA's circular describes: a registered product exists in Malaysia but is not on the market, so health facilities obtain the medicine through special approval instead. In RHMI's registry check, 6 of the 50 lines have a matching active registration as of 1 October 2026; whether each is marketed today needs separate verification.
How does the 2025 UKK list compare with 2024?
On RHMI's matching, 38 of the 50 lines also appeared on the 2024 list and 12 are new, led by amitriptyline 25 mg and 10 mg tablets. NPRA reports that four products from the 2024 list have since been registered; none of them is on the 2025 list.
Does a product on the UKK list guarantee sales in Malaysia?
No. The list shows special approval applications in 2025, not purchase commitments, and registration by itself does not establish formulary listing or purchasing. It is public evidence of UKK requests for a specific medicine, form and strength.
When will the next UKK list be published?
NPRA has not announced a date. The 2024 list was published in May 2025 and the 2025 list in April 2026. We will update this page when the next list appears.
Can a foreign manufacturer register a product from the list itself?
Not as the holder. For the standard commercial route, the registration is held by a Malaysian company that meets NPRA's applicant requirements - the Marketing Authorisation Holder (MAH). The manufacturer can use its own Malaysian subsidiary, a distributor or an independent MAH.
You might also find useful
- Malaysia's Medicine Shortage Reporting Rules (2026): What Every MAH Must Now Do
- Can a Foreign Manufacturer Hold a Drug Registration in Malaysia?
- Sources:
- NPRA circular NPRA.600-1/9/12(32), 16 April 2026 - Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2025: npra.gov.my (PDF)
- NPRA circular NPRA.600-1/9/12(28) - the same list for 2024: npra.gov.my (PDF)
- Ministry of Health - Garis Panduan Permohonan Ubat Kelulusan Khas (UKK) bagi Fasiliti-fasiliti KKM: pharmacy.moh.gov.my
- Ministry of Health - Approved Pharmaceutical Products dataset (updated 1 October 2026): data.moh.gov.my
- NPRA - QUEST3+ Product Search: quest3plus.bpfk.gov.my
- Editorial note: This page is general business and regulatory information for manufacturers evaluating Malaysia. It is not legal, regulatory or medical advice. NPRA's data is reproduced as published; the 2024 comparison and registry columns are RHMI's own analysis as of 1 October 2026 and may not reflect later registrations. Confirm product status in QUEST3+ before acting. Last reviewed: 16 October 2026.