Halalsphere

Understanding the Malaysian halal certification framework for medical devices

Nur Azira Tukiran — 2026-07-31

This short communication analyses Malaysia’s halal certification framework for medical devices using document analysis of the Manual Prosedur Pensijilan Halal Malaysia (Domestik) 2020 (MPPHM), as amended in 2026, the Malaysian Halal Management System 2020 (MHMS), MS 2636:2019, and relevant medical-device legislation. The analysis shows that halal certification functions as an additional assurance layer built upon regulatory compliance. Within this framework, MPPHM establishes regulatory eligibility through registration with the Medical Device Authority (MDA) or an exemption, and through establishment licensing. MHMS provides halal management through the Halal Assurance System (HAS) or Internal Halal Control System (IHCS). At the same time, MS 2636:2019 defines technical requirements for materials, manufacturing, premises, contamination control, packaging, traceability, and internal audit. Collectively, these documents integrate regulatory, certification, management, and technical controls to safeguard the halal integrity, safety, and quality of medical devices.

Operationalizing halal assurance within the quality-by-design pharmaceutical development lifecycle: A conceptual framework for biopharmaceutical development

Yumi Zuhanis Has-Yun Hashim — 2026-07-31

development. However, existing halal assurance and regulatory frameworks remain largely focused on organizational governance, material compliance, certification, traceability, and risk management, without explicitly operationalizing halal assurance within the Quality-by-Design (QbD) pharmaceutical development lifecycle. This Short Communication proposes a conceptual framework that operationalizes halal assurance across each stage of the QbD lifecycle, from the Quality Target Product Profile (QTPP) through Product Lifecycle Management. Rather than introducing a separate halal management framework, the proposed framework complements existing halal governance by embedding halal assurance within established pharmaceutical quality principles, thereby providing a practical foundation for systematic, proactive, and lifecycle-oriented halal biopharmaceutical development.

From Source to Assurance: Charting the Next Frontier of Halal Research

Yumi Z.H-Y Hashim — 2026-07-31

Editorial note - no abstract

MS 2424:2019: A mini review on contemporary issues and challenges of halal pharmaceuticals in Malaysia

Nur Hanie Mohd Latiff — 2026-07-31

The demand for halal pharmaceutical products has increased significantly due to growing consumer awareness and the need for medicines that comply with Shari’ah principles while ensuring safety, quality, and efficacy. Despite the introduction of the Malaysian Standard MS 2424:2019, implementing halal pharmaceutical requirements remains challenging due to complex supply chains, diverse raw material sources, and sophisticated manufacturing processes. Although previous studies have focused on specific issues such as animal-derived ingredients and halal certification, limited attention has been given to the broader implementation challenges addressed by MS 2424:2019. Therefore, this review examines the contemporary implementation challenges affecting Malaysia's halal pharmaceutical industry and analyses the role of MS 2424:2019 in safeguarding halal integrity. A qualitative literature review was conducted by systematically analysing peer-reviewed articles, conference papers, industry reports, regulatory documents, and MS 2424:2019, followed by thematic analysis. The review identified three major challenges: raw material traceability, cross-contamination during manufacturing, and limited halal knowledge and competency among industry stakeholders. The findings further highlight the importance of Halal Assurance Systems, supplier verification, documentation, and personnel competency in maintaining halal integrity. Overall, MS 2424:2019 provides a comprehensive framework for addressing these challenges. However, its effective implementation requires transparent supply chain management, competent personnel, and collaborative efforts among industry, regulatory authorities, and other stakeholders to strengthen the sustainability and global competitiveness of Malaysia's halal pharmaceutical industry.

demand for halal pharmaceutical products has increased significantly due to growing consumer awareness and the need for medicines that comply with Shari’ah principles while ensuring safety, quality, and efficacy. Despite the introduction of the Malaysian Standard MS 2424:2019, implementing halal pharmaceutical requirements remains challenging due to complex supply chains, diverse raw material sources, and sophisticated manufacturing processes. Although previous studies have focused on specific issues such as animal-derived ingredients and halal certification, limited attention has been given to the broader implementation challenges addressed by MS 2424:2019. Therefore, this review examines the contemporary implementation challenges affecting Malaysia's halal pharmaceutical industry and analyses the role of MS 2424:2019 in safeguarding halal integrity. A qualitative literature review was conducted by systematically analysing peer-reviewed articles, conference papers, industry reports, regulatory documents, and MS 2424:2019, followed by thematic analysis. The review identified three major challenges: raw material traceability, cross-contamination during manufacturing, and limited halal knowledge and competency among industry stakeholders. The findings further highlight the importance of Halal Assurance Systems, supplier verification, documentation, and personnel competency in maintaining halal integrity. Overall, MS 2424:2019 provides a comprehensive framework for addressing these challenges. However, its effective implementation requires transparent supply chain management, competent personnel, and collaborative efforts among industry, regulatory authorities, and other stakeholders to strengthen the sustainability and global competitiveness of Malaysia's halal pharmaceutical industry.

Islamic public value of halal certification acceleration program: A case study of policy practice by the East Java Provincial Government, Indonesia

Moh Suma Firman Romadhoni — 2026-07-31

This study aims to explore Islamic Public Value as the driving force behind the East Java Provincial Government's policy to accelerate halal certification, based on the Neo-Weberian State public administration paradigm. This research approach is qualitative, with an exploratory case study design, to understand in depth the dynamics of values and themes arising in the policy context. Data collection techniques included in-depth interviews, document analysis, and participatory observation. The data were analysed thematically to identify patterns of values that emerged during policy implementation. The results show that there are patterns of Islamic public values articulated in three main themes: (1) the application of Islamic Shari’ah principles in public services which is reflected in the government's commitment to ensure halal products in accordance with Shari’ah principles, (2) strengthening social cohesion through collaboration between stakeholders where this policy serves as an instrument to strengthen the solidarity of Muslim communities through guaranteeing halal consumption, and (3) social respect and encouragement of non-material motivations that emphasize moral-spiritual aspects such as justice, transparency, and social responsibility in policy implementation. These findings show that the policy of accelerating halal certification is not only oriented towards administrative interests, but also enriches the dimensions of public value derived from Islamic values. This research is expected to make a conceptual contribution to the development of public value studies in policy and to offer practical implications for the formulation and implementation of value-based policies at the local government level

Halal integrity risks and compliance strategies in non-halal-certified food SMEs in Negeri Sembilan: A descriptive study

Siti Syahirah Saffinee — 2026-07-31

The halal food sector plays an important role in maintaining consumer confidence in Malaysia, where most of the population is Muslim. Although Malaysia has an established halal certification system, more than 90% of food and beverage businesses are small and medium-sized enterprises (SMEs), many of which operate without halal certification. This raises concerns about how halal integrity is maintained in daily operations, as non-certified businesses may rely on personal religious understanding and informal practices. This study aims to identify halal integrity risks among non-certified SME food establishments and examine the practices and challenges they face in maintaining halal compliance. Data were collected via a 22-item online questionnaire administered to 41 SME operators and employees in Nilai and Tampin, Negeri Sembilan. The data were analysed using SPSS, including reliability testing and descriptive statistics. The findings showed strong awareness of halalan toyyiban (87.8%) and farm-to-table traceability (82.9%). However, gaps were found in supplier verification: 45% were unaware of their suppliers’ official halal status, and only 12.2% conducted on-site verification. While utensil segregation was widely practised (87.8%), documentation remained weak (34.1%). The main challenges were infrastructure costs (mean = 4.48) and administrative complexity (mean = 4.21). The study recommends repositioning the SME Halal Integrity Shield (SHIS) as a practical tool to facilitate the adoption of the Internal Halal Control System (IHCS) under MPPHM 2020, as amended by Pekeliling Bil. 1/2026.

Operationalising Maqasid al-Shari‘ah through toyyib principles in labour ethics: Challenges and recommendations for the garment industry in Bangladesh

FARHANA AHAMAD — 2026-07-31

The ready-made garment (RMG) industry of Bangladesh contributes significantly to the national economy but remains ethically fragile due to poor working conditions, wage injustice, and unsafe environments. This study operationalises toyyib as an applied ethical lens grounded in Maqasid al-Shari’ah to examine labour practices, identify ethical violations, and propose reform pathways. Data were collected through 22 semi-structured interviews where workers, managers, policymakers, and Islamic scholars participated. The findings reveal misalignment between existing labour practices and Islamic ethical requirements, particularly in relation to wages, working hours, workplace safety, hygiene, rest facilities, and the protection of workers’ dignity. These issues are compounded by weak law enforcement and a lack of awareness of Islamic ethical obligations. The study advances Islamic labour ethics by empirically translating Maqasid objectives into assessable workplace conditions through the concept of toyyib.

Galactomyces ferment filtrate in cosmetics: A jurisprudential analysis via Istihalah

Nazratul Huda Mohd Nadhir — 2026-07-31

This study examines the permissibility (halal) status of Galactomyces Ferment Filtrate (GFF) in cosmetic products through the Islamic jurisprudential principle of Istihalah (transformative purification). Commercially known as Pitera (TM), GFF is a yeast-derived bioactive ingredient widely used in skincare yet associated in popular discourse with sake (Japanese rice wine), raising purity (I) concerns among Muslim consumers. Using a qualitative library research methodology, the study analyses GFF across three stages: its biological source and characteristics; its industrial production process; and the application of Istihalah to assess the completeness of the transformation. Classical juristic positions from the four Sunni schools and contemporary scholarly opinions are surveyed alongside scientific literature. The findings demonstrate that downstream processing eliminates all ethanol from the final ingredient, satisfying the conditions for Istihalah Sahihah. GFF is therefore classified as tahir (pure) and halal for cosmetic use.

Veterinary laboratories as a strategic mechanism for public health protection and halal industry development in Brunei Darussalam

Siti Nur Arinah Saiful Azmi — 2026-07-31

The concept of halalan toyyiban emphasises that food products must not only comply with halal requirements but also be safe, wholesome, and of good quality. Veterinary laboratories contribute to this principle through scientific testing that supports food safety, public health, and halal assurance. This study aimed to examine the role of Veterinary Laboratory Services (VLS) in safeguarding public health and supporting halal assurance in Brunei Darussalam. A qualitative approach was used, involving semi-structured interviews with six participants, including VLS personnel and an industry representative. Thematic analysis revealed that VLS supports public health through disease surveillance, microbiological testing, molecular analysis, and food safety assessment. Although VLS does not perform halal certification, its laboratory services provide scientific evidence that strengthens halal integrity. Challenges related to human resources, resources, equipment, and accreditation were also identified.

Halal food control systems: A bibliometric review of the global knowledge structure and research gaps, with critical reflections for the Gulf Region

Abdulaziz Al-Saab — 2026-07-31

This study presents a bibliometric and critical review of global research on halal food control systems, with particular attention to countries developing new halal regulatory frameworks, including Saudi Arabia and the wider Arab region. A systematic review of Scopus-indexed publications from 2010 to 2025 was conducted following PRISMA guidelines. The final global corpus comprised 847 peer-reviewed articles analysed using VOSviewer and Biblioshiny through co-authorship, co-citation, bibliographic coupling, keyword co-occurrence, and thematic evolution analyses. An additional subset of 82 Arab-region studies, covering Gulf Cooperation Council and wider Arab League states, was manually coded using the FAO/WHO five-component national food control system framework. The field grew at an annual rate of 18.3%, with Malaysia and Indonesia contributing 43% and 28% of publications, respectively. Five major research clusters were identified: fatwa-based legislation; multi-agency governance; inspection, enforcement, and laboratory systems; information, education, communication, and training; and emerging technologies, including blockchain and artificial intelligence. Despite rapid growth, the literature remains geographically concentrated, theoretically underdeveloped, methodologically homogeneous, and largely silent on the cost-benefit implications of halal control systems. Few studies integrate Maqasid al-Shari’ah with risk-management approaches or examine halal governance as a complete regulatory system. By applying the FAO/WHO framework, this review moves beyond isolated certification and supply-chain perspectives. It demonstrates that Arab-region halal governance exhibits a distinctive “law-rich but evidence-poor” profile and proposes a research agenda addressing institutional performance, empirical evidence, regulatory effectiveness, and economic trade-offs.

Loop-mediated isothermal amplification for detection of porcine adulteration in meat and gelatine-based products: Analytical performance and potential applications

Raja Mohd Hafidz Raja Nhari — 2026-07-31

Porcine-derived products, including pork gelatine and lard, are commonly associated with undeclared food additives or contaminants. Deoxyribonucleic acid (DNA)-based approaches are typically considered the most reliable strategy for species authentication in food products due to DNA's stability in processed food matrices and its high specificity. Loop-mediated isothermal amplification (LAMP) has emerged as a viable method for rapid DNA detection in isothermal conditions, requiring minimal instrumentation and offering high sensitivity and robust inhibitor tolerance. This review discusses the past and current literature on LAMP assays for detecting porcine adulteration in meat and gelatine. At the same time, there is still a lack of studies involving the detection of lard adulteration in fat-based products. It also discusses several important factors, such as assay design, target gene selection, detection formats, and matrix-dependent analytical performance. A comparison of LAMP with quantitative polymerase chain reaction (qPCR) demonstrates LAMP's advantages in rapid screening, high specificity, and ease of use. Limitations and possible future avenues for incorporating LAMP into food control initiatives were also discussed.