News/Photo

E-Labelling sharing session: From PDF to FHIR ready XML

1. FHIR & PI fundamental
2. Proposed implementation process flow
3. Country specific (Jorddn) experience: Challenges, Mitigation & Readiness.
4. Malaysia E-labelling implementations & NPRA directions.

Technical Committee Meeting on Medicines and Medical Devices security Number 1/2026

Feedback was provided from all the industry representatives of pharmaceutical (MAPS, MOPI and Phama) and medical devices industries. In the meeting it was revealed that pharmaceutical supplies were still adequate, although prices are facing pricing challenges. Only about a dozen pharmaceutical products may face some supply challenges.

Global Supply Crisis: Can Healthcare Sytems Cope

Dialogue with Pharmaceutical Service Program on impact of Gulf Conflict

Next steps

PSP Pn Nur Ain to

• Discuss with Amalan team about the possibility and process for issuing forward/advance POs (for up to 6 months) for tender and Lampiran Q products, and provide feedback
• Engage with NPRA to facilitate/prioritize approval for alternative suppliers (as per Apex Pharmacy's request and potentially others)
• Review and consider requests for exemption from penalties on a product basis if companies submit such requests
• Facilitate discussions with relevant authorities to expedite awarding of KKM contracts where possible
• Share contact/email details (ain.shuhaila@moh.gov.my) with participants for submission of product lists and concerns
• Raise the issue of fuel supply prioritization for essential industries (including pharmaceutical logistics) at higher government levels

• All companies can email Pn Nur Ain (ain.shuhaila@moh.gov.my) team with details of specific products (including tender/LPO/Lampiran Q items) that may face supply or price issues, so MOH can facilitate and discuss with relevant teams

MOPI Webinar 3-2026: Patent Linkage Implementation under CPTPP

1. Eligible patent : too broad coverage for all patent.
2. Not clear in the guideline if registration process will be halted in the 12 months suspension period or registration process ongoing as per verbally informed to industry on 11 Mar 2026

Preparing for Pharmaceutical Track & Trace in Malaysia

Annual General Meeting 2026

Dunas Meeting Component 1

1. 4 strategies, 6 initiatives and 12 indicators were presented with 92.3% achievements reached.
2. Garispanduan on credentialing for registered pharmacist uploaded to portal pharmacy. gov.my.
3. Module GGM for private sector ongoing with dialogue held on 24 Feb 2025.
4. No payment or charges required for renewal of credentialing.
5. 99.32% adoption by MOH Hosp, PKD, & KK adopted the guidelines.
6. Strethening of SDO 1952, discussion of the draft with AGC through 3 discussion sessions. Tabled in June 2026 in parliament.
7. ROPA 1951 delay. Focus on SODA 1952.
8. MASA 1956, finalizing & drafting the proposal paper for MOH top management approval by Q2 2026.
9. Altogether 9 credentialing modules for pharmacists approved.
10. a total of 55 MOH RX credentiated, 19 Pharmacy assistant being credentiated.

Discussion on Medicine status caused by Middle East Conflict

The priority would be to ensure supplies of essential and single source medicines. Concerns over escalation of costs in direct and indirect consequences of fuel prices were also discussed. A multi-party task force of stakeholders for purpose of monitoring this situation will be set up, and the draft terms of reference has been prepared.
We urge all members to co-operate with the Pharmacy Services Progam in their information gathering when the mechanism is set up, and assurances of confidentiality has been given. Let us work together to ensure that our nation makes it through this difficult time.

E-labelling committee meeting Bil 1 2026

1. E-labelling surveys on the effectiveness and perception of Public, HCP and Industry/NPRA was presented by Dr June Choon (Sunway University). Age is the limiting factor to using E-labelling. 82% of age >60 are less likely to use E-labelling.
2. The use of XML to replace PDF format for PI was presented by Mr Kobu, to start with Quest 5 live 1 implementation w.e.f Sept 2027.
3. DHCP letter to be omitted after agreement obtained from PBKD in April 2026

2nd Engagement Session on Implementation of Patent Linkage

1. Purpose is to inform all stakeholders on the latest updates of the patent linkage guidelines, explained operational procedures of Quest 3+.
2. Patent linkage applies to all pharmaceutical products but excludes biologics.
3. Only applies to product patents and indication patents. It excludes manufacturing process patent, formulation patents, polymorphs, salts/esters, dosage form and packaging patents.
4. Category 1,2, 3 products need not go through patent linkage.
5. Notification Only applies to category 4 products, whereby it may infringe patents, notifications 45 calendar days, Acknowledgements 20 days, Suspension up to 12 months if there's litigation.
6. UPC will be held from 1 to 30 April for industry to provide feedback

Dunas Meeting Component 2

1. Sales of drugs (medicinal product for clinical trial) SODIP approved on 28 Mar 2025. UPC concluded from 17 Oct 25 to 17 Nov 25. Subject to SODA amendment approval by parliament, schedule to be tabled in June 2026. If things proceed smoothly Act to be gazetted in Oct 2026.
2. WHO maturity level 3, non-legal IDP 65, Legal IDP 19. To achieve benchmarking by WHO ML3 by 2026.
3. Tabung Amanah Latihan (L720) set up for Donation to achieve ICH membership. However industry donation need to subject to Jawatankuasa Akaun Amanah for approval since there maybe conflict of interest.
4. Cell & Gene Therapy Registration. Survey conducted on registration barriers to the approval of CGT in Malaysia. Research ended Mar 26. The applications for GMP (8 applications), CTIL/CTX (2), Reg application (1), Reg approval (1) (Zolgensma)
5. NPRA as statutory body, MOF disagreed, proposed to change to Autonomous Body instead. Task force formed on 11/9/2025 with Zaid Ibrahim & co invited to assist.
6. Track & Trace. Tender contract awarded to Netsmart Sdn Bhd on 1 Oct 25 for a duration of 6 years, to set up repository. Q2 26 to Q2 27 to set up PTTS, Q2 27 to Q2 28 will include industry. There are complaints on the quality of the new hologram and on difficulty to scan using MyUbat. Duopharma shared 4 to 5 counterfeit products detected last year. Important to set up track & trace to ward off counterfeit medicines.
7. Clinical trial on First in Human Study. 2 applications done locally. Current site: SUS & Ampang. Site submitted for approval: UMMC, Sunway, UITM.
8. E-labelling. 1011 Products approved. [biologics 52, NDP 290, Generics 625, OTC 44]
9. Combating online sales of illegal & falsified medicines 98.54% reduction. Removed 14641, caught seller 522, enforcement achieved 99.57%.
10. PV inspection 9 PRHs inspected. Draft guideline to be fine-tuned.
11. FRP. NCE 27, Biologics 17 Generics 12. Singapore as reference country maybe only for NCE because generics do not have evaluation report.

Dunas Meeting Component 3

1. MOPI presented predatory pricing by MNC affecting local generics launching. Duopharma spent RM30M + RM2M in CAPEX and R&D on Trevive, but Norvartis drop prices of Glivec fr RM6000 to RM 1000. Similarly, Roche drop prices of Herceptin from RM6000 to RM3000. PhAMA mentioned the short timeframe of 5 to 6 years only to market in Malaysia before losing patent. Solution from A&P: to award tender to 2 products to get maximum benefits. MAPS mentioned one of the solutions is to shorten registration timeframe. NPRA responded Quest 5 and future AI evaluation will shorten the time of registration
2. Draft formulary TCM has been approved in Oct 2025. Directive will be sent out soon
3. Medicine shortage Google form implemented. It will be mandatory by 1 July 2026. Guideline on reporting of medicine shortage and discontinuation already uploaded to NPRA website
4. A&P noticed many medicines increase their prices comparing from KPK approval to registered product. APHM cited no competition leads to that. MAPS mentioned the need to meet registration requirements like Zone 4B and BE pushed said drug prices higher. Consensus: quality and safety still the priority and registered drugs ensure regular availability of medicines
5. No initiative yet to do Drug pricing control. Even setting ceiling price is deemed not feasible, as it will affect accessibility of Medicines
6. Pharmacoeconomic framework is mandatory for listing into Drug formulary
7. Guideline for submission of dossier for listing into the MOH Formulary to be implemented before Dec 2026
8. To shorten timeline of accessibility of new medicine, PhAMA suggest doing concurrent registration and blue book listing process
9. 8th NEML will be revised and published in 2026
10. 15 generics granted priority review approval
11. MH Nexus awarded with Quest 5 tender and SST signed on 2 Jan 2026
12. Pool Procurement of Public and Private framework developed but deem this initiative not able to be carried out due to inability to guarantee benefits to the public
13. Joint API stockpiles proposed instead by Malaysia Productivity Corporation
14. Price transparenvy mechanism to display prices at private sector faced objection from Drs and Dental Associations. Court grants interim suspension to this initiative
15. National Generics Medicines and Biosimilars framework developed in June 2025
16. Objective is Affordability and accessibility of medicine with enhanced competition to manage price escalation of medicines
17. 5 strategies, 15 Initiatives and 17 Indicators with 70.58% achieved.

Dunas Meeting Component 5

1. Objective is to discuss the progress of 8 Strategies, 9 initiatives and 12 indicators, whereby % of achievement is 83%.
2. Pilot project with Alpro Pharmacy on safe medicines disposal has been completed. Awaiting data publication.
3. Outsourcing of patient follow up Med supply from MOH facilities to community pharmacies pilot project in Penang ended. The fees are borne currently by MOH. For phase 2, fees (management, reimbursement and possible pool procurement) yet to be finalized. Perhaps can work with state governments. This pilot project involved 2000 patients. Duration of pilot is one year until 24 Dec 2026.
4. ADSSR plan of action presented during ASEAN meeting in 22 to 25 Sept 2025. 9 activities agreed upon. ADSSR framework to be drafted in 2026. My MedSecurity is one of the initiatives.
5. Established My MediSafe blueprint. Launched on 25 Sept 2024.
6. 3 private laboratories recognised to conduct assay and tests on traditional active ingredients.
7. Feasibility study conducted on sending e-prescription from MOH facilities to the private sector. Currently using Mysejahtera and MyUbat Apps. However, only facilities using the same Pharmacy Information System (PHiS) can access.
8. Track and trace tender has been awarded.
9. June 2026 Bengkel DUNAS will be held.

Dunas Meeting Component 4

1. Moving forward will invite Shopee, Lazada and Tik Tok to handover declaration on ToBAT (Tolak Ubat Tidak Sah) in conjunction with National Regulatory Conference in July 2026
2. Braille products currently not in tender specification. However, PRH can put braille as a value-added benefit during tender submission
3. Draft on Good Dispensing Practice on the way
4. Amendment on sales of drug act to be tabled to parliament in July 2026.

MyCEB and RSE Meeting with MAPS

1. tHIS (The Health Industry Series) for Asean participants dated 28-30 July 2026 at KLCC Convention Center. Organizer: RSE + APHM.
2. PharmChina dated 13-15 May 2026 Shanghai with 4500 distributors and 2000 exhibitors. The biggest exhibitions for pharmaceuticals in China
3. China International Medical Equipment Fair dated 9-12 April 2026 at Shanghai with 5000 exhibitors.

1. Regulatory hurdles. (GMP inspections , Zone 4B, BE etc)
2. Volume hurdles. (Expectation and batch size too big for Malaysia market)

View Archived News