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Pharmaceutical Association of Malaysia

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Pharmaceutical Association of Malaysia

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The Pharmaceutical Association of Malaysia (PhAMA) aims to make innovative medicines accessible to Malaysians through four key pillars:
1) Strategic Partnerships
2) Advocacy
3) Industry Support
4) Capability Building

29/05/2026

PhAMA (Pharmaceutical Association of Malaysia) is seeking a Lead, Healthcare System Partnership to drive strategic initiatives in shaping conducive healthcare environment within Malaysia’s evolving healthcare landscape. This role combines policy analysis, strategic partnerships, and effective engagement within Malaysia’s healthcare environment, alongside industry coordination to support innovation, patient access, and compliance across the pharmaceutical ecosystem. You will work cross-functionally with member companies, committees, and external stakeholders to advance key workstream priorities, while providing critical strategic and technical leadership on pharmaceutical policy matters.

If you are interested, please email your resume before 15 June 2026 to [email protected]

26/05/2026

Malaysia Advances Towards HL7 FHIR ePI

At the MOH–Industry E Labelling Committee meeting on 12 March 2026, NPRA announced plans to adopt the QUEST5 system to encompass XML FHIR e labelling. This marks a pivotal shift from static PDF labels to FHIR XML format, enabling true interoperability where PHIS and hospital EMR systems can seamlessly integrate e labelling into clinical workflows.

To support this vision, PhAMA organized a technical sharing session on 5 May 2026 for stakeholders to look into Malaysia’s Plan Towards HL7 FHIR ePI. The session brought together regulators, industry leaders, and global experts to:
• Introduce FHIR ePI fundamentals
• Share proposed implementation process flow
• Identify readiness gaps and next steps

Esteemed speakers included:
• Mr Craig Anderson (J&J)
• Ms Li Jia Hui (Pfizer)
• Mr Kobu A/L Thiruvanackan (NPRA)
• Dr Ariff Bin Azahar (MHNexus)
And supported by Dr Rie Matsui (Pfizer Japan, APAC e labelling EWG Leader).

Topics ranged from country experience in Jordan to Malaysia’s implementation direction, with candid discussions on challenges, mitigation, and readiness.

PhAMA is proud to have successfully convened this session, helping regulators and industry stakeholders gain deeper insights into the transition from PDF to FHIR ready XML e labelling—a step forward in ensuring medicine information is up to date, interoperable, and accessible.

21/05/2026

As healthcare systems evolve, incorporating broader societal perspectives into Health Technology Assessment (HTA) is becoming increasingly important.

Join us at the upcoming PhAMA Value-Based Healthcare Forum 2026 — a platform bringing together healthcare leaders, HTA experts, policymakers, academia, and industry stakeholders to explore how societal value can be better integrated into healthcare decision-making in Malaysia.

Date: 16 June 2026
Time: 8:00 AM – 4:00 PM
Venue: Sheraton Petaling Jaya

Register here: http://t2u.asia/e/49714_723b79b853354188808d4eff923c02bc

20/05/2026

In the pursuit of innovative therapies through clinical trials, the most critical bridge is the one that connects global breakthroughs to local patients, enabling early access to life-changing treatments. PhAMA believes that access to innovation cannot be delayed — it must remain a national priority, placing patients at the centre of healthcare advancement.

PhAMA members play a pivotal role in closing this gap by bringing high-impact clinical trials into Malaysia. Beyond conducting studies, we are enabling earlier access to cutting-edge therapies—often years ahead of commercial availability—giving patients early access to new options when they are needed most.

The progress achieved today is the result of sustained momentum and long-term commitment. Since 2012, Malaysia has seen over 2,800 sponsored clinical research studies, with PhAMA members serving as a key driver in positioning Malaysia as a leading clinical research hub in Asia. By bringing global clinical trials into Malaysia, internationally aligned standards have been further embedded across the ecosystem, while local capabilities continue to advance through knowledge transfer and workforce development. These collective efforts have reinforced Malaysia’s reputation for clinical research excellence, robust trials quality, and scalability.

As Malaysia’s clinical research ecosystem continues to evolve, PhAMA members remain committed in supporting Malaysia’s progression into more advanced areas of research, including First-in-Human (FIH) studies. Through strategic partnerships and constructive regulatory engagement, PhAMA continues to support efforts to strengthen enabling frameworks that will enhance Malaysia’s readiness to conduct advanced clinical trials and contribute meaningfully to the next generation of medical innovation.

On this International Clinical Trials Day, PhAMA recognises the collaboration between stakeholders across policy and science that drives early patient access to innovative therapies, sustaining patient hope at the core of clinical research progress. The future of medicine in Malaysia is not merely being anticipated — it is being actively shaped through ongoing collaboration, innovation, and shared commitment.

15/05/2026

On 22 April 2026, PhAMA participated in the first-ever joint IFPMA–APAC pharmaceutical associations meeting which was held in conjunction with the 15th APAC meeting, marking an important milestone in establishing a new regional platform for collaboration among pharmaceutical associations across Asia.

The meeting provided a valuable opportunity to align regional perspectives with ongoing work in Malaysia, particularly in strengthening a predictable, innovation-friendly, and patient-centred healthcare ecosystem.

Key discussions reflected shared regional challenges and priorities. In the context of growing geopolitical pressures, which continue to shape the operating environment, there is an increasing need for greater regional and global unity to strengthen resilience and ensure continued patient access to medicines.

These evolving policy directions further reinforce the importance of maintaining a balanced approach—one that supports both the strengthening of local health systems and sustained investment in innovative medicines. There was also strong consensus that robust intellectual property (IP) protection, data exclusivity, and predictable policy environments are key enablers of innovation and long-term investment, besides ongoing efforts to enhance regulatory efficiency and accelerate patient access to innovative medicines.

PhAMA extends its appreciation to Dr David Reddy, Director General of IFPMA, Grega Kumer, Deputy Director, Government Relations, and Janis Bernat, Director, Scientific and Regulatory Affairs, for convening and leading this important regional dialogue, and for their continued efforts in strengthening collaboration across APAC.

PhAMA values its participation in this inaugural forum as a key step in strengthening regional dialogue and alignment. We remain committed to deepening collaboration through IFPMA and other global and regional partnerships to support a more resilient, innovative, and patient-centred healthcare ecosystem in Malaysia and across the region.

David Reddy, Director General IFPMA | Grega Kumer, Deputy Director, Government Relations | Janis Bernat, Director, Scientific and Regulatory Affairs | Jessie Leow |

13/05/2026

On 21 April 2026, the 15th Asia Partnership Conference of Pharmaceutical Associations convened in Tokyo, bringing together regulatory and industry leaders to shape the future of healthcare across Asia.

PhAMA was represented by Jessie Leow, Policy Manager, alongside members of the PhAMA Regulatory Affairs Committee, Soo Li Ping, Janice Tan & Siew Mei Long.

The conference highlighted several key regulatory priorities and emerging shifts across the Asia-Pacific region, including:
- Reliance and Joint Assessments: Expansion of accelerated reliance pathways for Marketing Authorisation Applications (MAAs) and Post-Approval Changes (PACs).
- E-labeling: Progression from PDF format to structured XML format and Fast Healthcare Interoperability Resources (FHIR) standards.
- AI and Digitalisation: Early adoption of artificial intelligence (AI) and digital tools to support more efficient regulatory processes and supply chain quality oversight.
- Universal Health Coverage (UHC): Continued focus on realizing UHC in Asia through Hybrid Financing models to improve patient access and healthcare sustainability.

We are also pleased to see strong participation from Malaysia, with NPRA Deputy Director, Rosliza Lajis and APAC RA-EWG member, Siew Mei Long contributing as panellists in the Regulatory Affairs session on Optimizing Reliance Pathways across the Product Lifecycle, and NPRA Head of ICT Section, Kobu Thiruvanackan sharing Malaysia’s strategic roadmap from PDF to FHIR-ready XML under the Empowering Patients Through e-Labelling session.

The conference serves as a valuable platform to exchange insights and strengthen regional collaboration towards more efficient, innovative, and patient-centric healthcare systems.

PhAMA remains committed to advancing policies and partnerships that support timely access to innovative medicines, while contributing to a resilient and future-ready healthcare ecosystem in Malaysia and across the region.

11/05/2026

PhAMA was pleased to participate in CRM Trial Connect 2026 alongside our member companies, supported by the strong contributions of PhAMA’s Clinical Research Committee members involved in advancing clinical trials in Malaysia, under the leadership of Committee Co-Chairs Dr. Svetlana and Mr. Sanjeev.

A sincere thank you to Clinical Research Malaysia (CRM), led by CEO Dr. Akhmal Yusof, for organising this important platform that continues to foster meaningful dialogue, collaboration, and partnerships in advancing the clinical research landscape in Malaysia and the region.

CRM Trial Connect 2026, themed “The Rise of Asia in Clinical Trials,” convened more than 1,200 participants from over 160 organisations across 20 countries, reflecting the growing importance of Asia as a key hub for clinical research and innovation.

The conference highlighted the importance of strengthening collaborative partnerships with international stakeholders while reinforcing Malaysia’s commitment to advancing clinical research. Discussions underscored the moral imperative of ensuring equitable access to health innovation, as well as the need for a trusted, predictable, and resilient ecosystem supported by clear regulatory frameworks, consistent governance, and strong institutions.

The Minister of Health, who officially opened the conference, reaffirmed Malaysia’s commitment to clinical research as a driver for improving lives, strengthening regional collaboration, and advancing innovation towards a healthier and more prosperous future.

PhAMA remains committed to supporting a robust and globally competitive clinical research ecosystem in Malaysia through continued collaboration with stakeholders, strengthening industry capabilities, and contributing towards an enabling environment that accelerates patient access to innovative therapies and medical advancements.

Jamal Malik | Evelyn Ho | Tia Chen | Irvine Pang | Mayuresh Fegade | Eng Min Li | Sarega Nadarajan | Sheikh Mohammad Norhafiz Abdul Aziz | Jessie Leow | Janice Law | Britney Choo | Carren Yew

07/05/2026

On 4 May 2026, PhAMA hosted an engagement with representatives from the Selangor Pharmacy Services Division, Federal Territory of Kuala Lumpur & Putrajaya Pharmacy Services Division, and the Pharmacy Enforcement Division under the Pharmaceutical Services Programme, Ministry of Health Malaysia.

The discussion formed part of Malaysian National Medicines Policy (DUNas) Component 5: Partnership and Collaboration for the Healthcare Industry, focusing on strengthening public-private partnerships (PPP). The dialogue centred on opportunities for collaboration between enforcement bodies and the pharmaceutical industry to address shared challenges, with the aim of uplifting pharmaceutical practice standards and achieving mutually beneficial outcomes.

Among the topics discussed were concerns relating to unregistered medicines and cosmetic products, as well as the importance of strengthening public awareness through joint enforcement-industry initiatives. In addition, opportunities were explored to strengthen capacity building through targeted workshops for industry stakeholders—particularly licensed pharmaceutical importers—as well as sessions on medicine advertisement regulations, as part of the efforts to enhance pharmaceutical regulatory standards.

PhAMA recognises the importance of public-private partnerships (PPP) in driving meaningful improvements that uphold and uplift high standards within regulatory practices and compliance, thus supporting patient access to registered and approved pharmaceutical products. PhAMA remains committed to contributing to such collaborative efforts in support of a more effective healthcare system in Malaysia.

Kam Ai Teng | Sally Kuah | Jessie Leow | Janice Law

17/04/2026

PhAMA was honoured to attend the MyMediSAFE Committee Meeting for 2026, chaired by YBrs. Dr. Azuana binti Ramli, Deputy Director General of Health (Pharmaceutical Services), Ministry of Health Malaysia. PhAMA was represented by Jessie Leow (Policy Manager) and Britney Choo (Programme Officer).

The meeting underscored the strong synergy between public and private sector stakeholders, reflecting a meaningful public-private partnership aligned with the National Medicines Policy (DUNas) Component 5: Partnership and Collaboration for the Healthcare Industry. During the session, the secretariat presented the new MyMediSAFE national blueprint, alongside key findings from public survey highlighting medication disposal behaviours and trends.

Over the past year, the MyMediSAFE national programme has demonstrated encouraging progress, driven by the collective efforts of strategic partners in cascading awareness and implementation nationwide. Building on the achievements and milestones of 2025, the secretariat has also outlined strategic priorities for 2026, including a technical meeting scheduled for May 2026 to further advance implementation efforts.

Since the inception of MyMediSAFE, PhAMA has actively supported this initiative and remains committed to partner with Pharmaceutical Services Programme in strengthening awareness of safe medicine disposal practices and expanding access to medicine disposal points. This initiative contributes to broader efforts in planetary health and supports the global call to action on antimicrobial resistance (AMR).

PhAMA remains committed to its partnership with the Pharmaceutical Services Programme, Ministry of Health Malaysia in advancing the continued progress and strengthening the impact of the MyMediSAFE initiative.

16/04/2026

Behind every milestone in clinical trials lies a greater impact — access to innovation.

Malaysia’s progress in First-in-Human (FIH) trials showcases how strategic investments in infrastructure, talent, and regulatory strength can translate into real value for patients and the healthcare system.

As more global sponsors expand FIH trials locally, Malaysia continues to move forward as a key hub for innovation, bringing cutting-edge treatments closer to patients.

Check out the PhAMA Unlocking Malaysia’s Potential in Clinical Trials Fact Book 2024 to learn more: https://www.phama.org.my/view_file.cfm?fileid=150

Address

C-18-2, 3 Two Square (Dataran Three 2), No. 2, Jalan 19/1
Petaling Jaya
46300

Opening Hours

Monday	08:00 - 17:00
Tuesday	08:00 - 17:00
Wednesday	09:00 - 17:00
Thursday	09:00 - 17:00
Friday	09:00 - 17:00

Telephone

+60379608322

Website

http://www.phama.org.my/

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