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Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia

Chow WL, Salleh NAM, Kang TS

Ther Innov Regul Sci, 2024 May;58(3):528-538.
PMID: 38376698 DOI: 10.1007/s43441-024-00620-x

BACKGROUND: Drug approval lag is the time difference for new medicine to obtain marketing authorization approval in the study country compared to the first global approval. Drug approval lag delays the availability of innovative medicine to patients. This may lead to delay in treatment and severe public health implications. The study aimed to determine drug approval lag in Malaysia, the factors associated with drug approval lag (drug characteristics, regulatory factors and applicant type) and the association of the submission lag and review time with the regulation change.
METHODS: All new pharmaceutical products approved between January 2015 and March 2021 were examined (n = 136) using publicly available information. Factors associated with drug approval lag were determined using multiple linear regression.
RESULTS: The median drug approval lag was 855 days. Drug approval lag was associated with drug characteristics and regulatory factors. Median submission lag and median review time for products which fulfilled the requirement for the new regulations (Conditional Registration/ Facilitated Registration Pathway) were shorter compared to products which did not fulfil the requirement.
CONCLUSION: Drug approval lag may delay the access of innovative medicine to patients, and this may lead to an increase in morbidity, mortality and healthcare costs. Good Regulatory Practices ensure efficient and transparent regulatory system which support the public health policy objectives in the most efficient way. The new regulations in Malaysia reduced the median submission lag and review time. The findings may be useful for regulators to consider for future policy development for medication access.
Fulltext Enhancing mechanical properties of chitosan/PVA electrospun nanofibers: a comprehensive review

Salleh NAM, Afifi AM, Zuki FM, SalehHudin HS

Beilstein J Nanotechnol, 2025;16:286-307.
PMID: 40041430 DOI: 10.3762/bjnano.16.22

This review examines strategies to enhance the mechanical properties of chitosan/polyvinyl alcohol (PVA) electrospun nanofibers, recognized for their biomedical and industrial applications. It begins by outlining the fundamental properties of chitosan and PVA, highlighting their compatibility and mechanical characteristics. The electrospinning process is discussed, focusing on how various parameters and post-treatment methods influence fiber formation and performance. Key strategies for improvement are analyzed, including material modifications through blending and structural modifications like fiber orientation and multilayer constructions, and surface modifications such as coating and functionalization. The review also covers advanced characterization methods to evaluate mechanical properties and provides a comparative analysis of different enhancement approaches. Applications in biomedical and industrial contexts are explored, showcasing the versatility and innovation potential of these nanofibers. Finally, current challenges are addressed, and future research directions are proposed to overcome these obstacles and further enhance the mechanical properties of chitosan/PVA electrospun nanofibers, guiding their development for practical applications.
Fulltext Demystifying the catalytic pathway of Mycobacterium tuberculosis isocitrate lyase

Ibeji CU, Salleh NAM, Sum JS, Ch'ng ACW, Lim TS, Choong YS

Sci Rep, 2020 11 03;10(1):18925.
PMID: 33144641 DOI: 10.1038/s41598-020-75799-8

Pulmonary tuberculosis, caused by Mycobacterium tuberculosis, is one of the most persistent diseases leading to death in humans. As one of the key targets during the latent/dormant stage of M. tuberculosis, isocitrate lyase (ICL) has been a subject of interest for new tuberculosis therapeutics. In this work, the cleavage of the isocitrate by M. tuberculosis ICL was studied using quantum mechanics/molecular mechanics method at M06-2X/6-31+G(d,p): AMBER level of theory. The electronic embedding approach was applied to provide a better depiction of electrostatic interactions between MM and QM regions. Two possible pathways (pathway I that involves Asp108 and pathway II that involves Glu182) that could lead to the metabolism of isocitrate was studied in this study. The results suggested that the core residues involved in isocitrate catalytic cleavage mechanism are Asp108, Cys191 and Arg228. A water molecule bonded to Mg2+ acts as the catalytic base for the deprotonation of isocitrate C(2)-OH group, while Cys191 acts as the catalytic acid. Our observation suggests that the shuttle proton from isocitrate hydroxyl group C(2) atom is favourably transferred to Asp108 instead of Glu182 with a lower activation energy of 6.2 kcal/mol. Natural bond analysis also demonstrated that pathway I involving the transfer of proton to Asp108 has a higher intermolecular interaction and charge transfer that were associated with higher stabilization energy. The QM/MM transition state stepwise catalytic mechanism of ICL agrees with the in vitro enzymatic assay whereby Asp108Ala and Cys191Ser ICL mutants lost their isocitrate cleavage activities.
Fulltext A Qualitative Investigation on the Roles of Social Support on Physical Activity Behaviour among the Rural-Dwelling Older Women in Malaysia

Marthammuthu T, Hairi FM, Choo WY, Salleh NAM, Hairi NN

Int J Environ Res Public Health, 2021 09 12;18(18).
PMID: 34574533 DOI: 10.3390/ijerph18189609

Despite many health benefits of physical activities, both physically and mentally, the majority of the older women in the rural areas of Malaysia are showing a low prevalence of physical activities. Understanding the roles of social support to improve physical activities is imperative to promote active and healthy ageing among the rural-dwelling older women in Malaysia. Hence, this qualitative study adopted an inductive design using 17 in-depth interviews to understand the role of social support on physical activity behaviour among the rural community-dwelling older woman in Kuala Pilah District, Negeri Sembilan, Malaysia from December 2019 to January 2020. Three categories of themes were identified in this study. Firstly, adaptive social support in terms of informational, companionship and emotional supports reported enhancing physical activity levels among older women. Secondly, the absence of help and assistance from the social network asserts independence and triggers the older women to perform the activities by themselves, thus engage in physically active lifestyles. Thirdly, lacking social support demotivate older women to be engaged in physical activities. In particular, loss of companionship support, poor acceptance or appraisal support, logistic issues to attend exercise programmes and neighbourhood safety and security issues were among the main barriers of physical activities reported by the older women. The main findings of this study shed some light on the exigency of strengthening social support from the social network to engage the older women in physical activities. The roles of social media, effective patient-doctor communication and interventions targeting the spouses and family members must be strengthened to create a supportive atmosphere to enhance physical activity levels among older women.
The Prevalence and Association Between Social Support and Physical Activity Among the Rural Community-Dwelling Older Women in a Southeast Asian Country

Marthammuthu T, Hairi FM, Choo WY, Salleh NAM, Naqiah Hairi N

J Aging Phys Act, 2023 Aug 01;31(4):611-620.
PMID: 36649719 DOI: 10.1123/japa.2022-0201

While physical activity ensures healthy aging, rural community-dwelling older women tend to be more physically inactive compared with their counterparts in Malaysia. As social support is one of the key determinants of physical activity, this retrospective, cross-sectional study investigated the prevalence of physical activity and its association with social support among 1,221 rural community-dwelling older women in Kuala Pilah, Negeri Sembilan, Malaysia. The prevalence of physical activity among older women was 45.1% with the highest prevalence reported for housework domain (52.3%). The total mean Duke Social Support index score was 27.24 ± 3.40. Multivariate analysis reported age, employment status, and income level to demonstrate significant association with the physical activity after adjusting for confounders. Older women with an increase in social interaction score were more likely (odds ratio = 1.22; 95% confidence interval [1.10, 1.34]; p < .001) to have high physical activity when adjusted for sociodemographic, health, mental health, and physical disability. Contrarily, older women with an increase in one subjective social support score were less likely (odds ratio = 0.91; 95% confidence interval [0.87, 0.96]; p < .001) to have high physical activity when adjusted for confounders. The findings were insightful to tailor interventions on promoting social support for physical activity enhancement among older women.
Fulltext Testing the Feasibility and Acceptability of Using an Artificial Intelligence Chatbot to Promote HIV Testing and Pre-Exposure Prophylaxis in Malaysia: Mixed Methods Study

Cheah MH, Gan YN, Altice FL, Wickersham JA, Shrestha R, Salleh NAM, et al.

JMIR Hum Factors, 2024 Jan 26;11:e52055.
PMID: 38277206 DOI: 10.2196/52055

BACKGROUND: The HIV epidemic continues to grow fastest among men who have sex with men (MSM) in Malaysia in the presence of stigma and discrimination. Engaging MSM on the internet using chatbots supported through artificial intelligence (AI) can potentially help HIV prevention efforts. We previously identified the benefits, limitations, and preferred features of HIV prevention AI chatbots and developed an AI chatbot prototype that is now tested for feasibility and acceptability.
OBJECTIVE: This study aims to test the feasibility and acceptability of an AI chatbot in promoting the uptake of HIV testing and pre-exposure prophylaxis (PrEP) in MSM.
METHODS: We conducted beta testing with 14 MSM from February to April 2022 using Zoom (Zoom Video Communications, Inc). Beta testing involved 3 steps: a 45-minute human-chatbot interaction using the think-aloud method, a 35-minute semistructured interview, and a 10-minute web-based survey. The first 2 steps were recorded, transcribed verbatim, and analyzed using the Unified Theory of Acceptance and Use of Technology. Emerging themes from the qualitative data were mapped on the 4 domains of the Unified Theory of Acceptance and Use of Technology: performance expectancy, effort expectancy, facilitating conditions, and social influence.
RESULTS: Most participants (13/14, 93%) perceived the chatbot to be useful because it provided comprehensive information on HIV testing and PrEP (performance expectancy). All participants indicated that the chatbot was easy to use because of its simple, straightforward design and quick, friendly responses (effort expectancy). Moreover, 93% (13/14) of the participants rated the overall chatbot quality as high, and all participants perceived the chatbot as a helpful tool and would refer it to others. Approximately 79% (11/14) of the participants agreed they would continue using the chatbot. They suggested adding a local language (ie, Bahasa Malaysia) to customize the chatbot to the Malaysian context (facilitating condition) and suggested that the chatbot should also incorporate more information on mental health, HIV risk assessment, and consequences of HIV. In terms of social influence, all participants perceived the chatbot as helpful in avoiding stigma-inducing interactions and thus could increase the frequency of HIV testing and PrEP uptake among MSM.
CONCLUSIONS: The current AI chatbot is feasible and acceptable to promote the uptake of HIV testing and PrEP. To ensure the successful implementation and dissemination of AI chatbots in Malaysia, they should be customized to communicate in Bahasa Malaysia and upgraded to provide other HIV-related information to improve usability, such as mental health support, risk assessment for sexually transmitted infections, AIDS treatment, and the consequences of contracting HIV.
Fulltext HIV treatment outcomes among people who acquired HIV via injecting drug use in the Asia-Pacific region: a longitudinal cohort study

Han WM, Jiamsakul A, Salleh NAM, Choi JY, Huy BV, Yunihastuti E, et al.

J Int AIDS Soc, 2021 05;24(5):e25736.
PMID: 34021711 DOI: 10.1002/jia2.25736

INTRODUCTION: Data on HIV treatment outcomes in people who inject drugs (PWID) in the Asia-Pacific are sparse despite the high burden of drug use. We assessed immunological and virological responses, AIDS-defining events and mortality among PWID receiving antiretroviral therapy (ART).
METHODS: We investigated HIV treatment outcomes among people who acquired HIV via injecting drug use in the TREAT Asia HIV Observational Database (TAHOD) between January 2003 and March 2019. Trends in CD4 count and viral suppression (VS, HIV viral load <1000 copies/mL) were assessed. Factors associated with mean CD4 changes were analysed using repeated measures linear regression, and combined AIDS event and mortality were analysed using survival analysis.
RESULTS: Of 622 PWID from 12 countries in the Asia-Pacific, 93% were male and the median age at ART initiation was 31 years (IQR, 28 to 34). The median pre-ART CD4 count was 71 cells/µL. CD4 counts increased over time, with a mean difference of 401 (95% CI, 372 to 457) cells/µL at year-10 (n = 78). Higher follow-up HIV viral load and pre-ART CD4 counts were associated with smaller increases in CD4 counts. Among 361 PWID with ≥1 viral load after six months on ART, proportions with VS were 82%, 88% and 93% at 2-, 5- and 10-years following ART initiation. There were 52 new AIDS-defining events and 50 deaths during 3347 person-years of follow-up (PYS) (incidence 3.05/100 PYS, 95% CI, 2.51 to 3.70). Previous AIDS or TB diagnosis, lower current CD4 count and adherence <95% were associated with combined new AIDS-defining event and death.
CONCLUSIONS: Despite improved outcomes over time, our findings highlight the need for rapid ART initiation and adherence support among PWID within Asian settings.