Displaying publications 1 - 20 of 26 in total

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  1. Abas A
    Biologicals, 2011 Sep;39(5):339-42.
    PMID: 21784655 DOI: 10.1016/j.biologicals.2011.06.009
    The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.
    Matched MeSH terms: Drug Industry/legislation & jurisprudence*
  2. Ashraf H
    Lancet, 2002 Aug 24;360(9333):627.
    PMID: 12241947
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence*
  3. Rampal KG, Aw TC, Jefferelli SB
    Occup Med, 2002 Jul-Sep;17(3):409-25, iv.
    PMID: 12028951
    This article provides a detailed examination of Malaysian occupational health agencies and their roles in formulating and enforcing standards, promoting occupational health and safety (OSH), and providing advisory services. Available OSH training is described, and the need for policies and personnel in various industries is outlined. Further, the authors discuss how international models and collaboration have influenced Malaysian OSH, and how some successes can be repeated and failures remedied.
    Matched MeSH terms: Industry/legislation & jurisprudence
  4. Ravindran TS, Teerawattananon Y, Tannenbaum C, Vijayasingham L
    BMJ, 2020 10 27;371:m3808.
    PMID: 33109511 DOI: 10.1136/bmj.m3808
    Matched MeSH terms: Drug Industry/legislation & jurisprudence*
  5. Sy DK, Stumberg RK
    Tob Control, 2014 Nov;23(6):466-70.
    PMID: 25170023 DOI: 10.1136/tobaccocontrol-2014-051900
    Twelve-member countries of the Asia Pacific Economic Cooperation (APEC) are negotiating the Trans-Pacific Partnership Agreement (TPPA), a free trade agreement to facilitate international trade and investment. As reported by multiple sources, the TPPA would grant the same trade benefits and legal protections to tobacco products, services and investments that it would provide to other sectors. Malaysia proposed excluding tobacco control measures from the scope of all TPPA chapters while the US proposed only to establish a consultation process in tobacco-related disputes and to declare that tobacco control measures serve a health objective within the scope of the general exceptions.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence*
  6. Assunta M, Chapman S
    Tob Control, 2004 Dec;13 Suppl 2:ii37-42.
    PMID: 15564218
    OBJECTIVE: To review tobacco company strategies of using youth smoking prevention programmes to counteract the Malaysian government's tobacco control legislation and efforts in conducting research on youth to market to them.
    METHODS: Systematic keyword and opportunistic website searches of formerly private internal industry documents. Search terms included Malay, cmtm, jaycees, YAS, and direct marketing; 195 relevant documents were identified for this paper.
    RESULTS: Industry internal documents reveal that youth anti-smoking programmes were launched to offset the government's tobacco control legislation. The programme was seen as a strategy to lobby key politicians and bureaucrats for support in preventing the passage of legislation. However, the industry continued to conduct research on youth, targeted them in marketing, and considered the teenage market vital for its survival. Promotional activities targeting youth were also carried out such as sports, notably football and motor racing, and entertainment events and cash prizes. Small, affordable packs of cigarettes were crucial to reach new smokers.
    CONCLUSION: The tobacco industry in Malaysia engaged in duplicitous conduct in regard to youth. By buying into the youth smoking issue it sought to move higher on the moral playing field and strengthen its relationship with government, while at the same time continuing to market to youth. There is no evidence that industry youth smoking prevention programmes were effective in reducing smoking; however, they were effective in diluting the government's tobacco control legislation.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence
  7. Assunta M, Chapman S
    Tob Control, 2004 Dec;13 Suppl 2:ii51-7.
    PMID: 15564221
    To review how tobacco transnational companies conducted their business in the hostile environment of Singapore, attempting to counter some of the government's tobacco control measures; to compare the Malaysian and the Singaporean governments' stance on tobacco control and the direct bearing of this on the way the tobacco companies conduct their business.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence
  8. Assunta M, Chapman S
    Tob Control, 2004 Dec;13 Suppl 2:ii43-50.
    PMID: 15564220 DOI: 10.1136/tc.2004.008094
    OBJECTIVE: To describe tobacco industry efforts in Malaysia to thwart government efforts to regulate tobacco promotion and health warnings.
    METHODS: Systematic keyword and opportunistic website searches of formerly private tobacco industry internal documents made available through the Master Settlement Agreement and secondary websites; relevant information from news articles and financial reports.
    RESULTS: Commencing in the 1970s, the industry began to systematically thwart government tobacco control. Guidelines were successfully promoted in the place of legislation for over two decades. Even when the government succeeded in implementing regulations such as health warnings and advertising bans they were compromised and acted effectively to retard further progress for years to come.
    CONCLUSION: Counter-measures to delay or thwart government efforts to regulate tobacco were initiated by the industry. Though not unique to Malaysia, the main difference lies in the degree to which strategies were used to successfully counter stringent tobacco control measures between 1970 and 1995.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence
  9. Dalton R
    Nature, 2004 Feb 12;427(6975):576.
    PMID: 14961086
    Matched MeSH terms: Drug Industry/legislation & jurisprudence
  10. Scott KP, Grimaldi R, Cunningham M, Sarbini SR, Wijeyesekera A, Tang MLK, et al.
    J Appl Microbiol, 2020 Apr;128(4):934-949.
    PMID: 31446668 DOI: 10.1111/jam.14424
    AIMS: The concept of using specific dietary components to selectively modulate the gut microbiota to confer a health benefit, defined as prebiotics, originated in 1995. In 2018, a group of scientists met at the International Scientific Association for Probiotics and Prebiotics annual meeting in Singapore to discuss advances in the prebiotic field, focussing on issues affecting functionality, research methodology and geographical differences.

    METHODS AND RESULTS: The discussion ranged from examining scientific literature supporting the efficacy of established prebiotics, to the prospects for establishing health benefits associated with novel compounds, isolated from different sources.

    CONCLUSIONS: While many promising candidate prebiotics from across the globe have been highlighted in preliminary research, there are a limited number with both demonstrated mechanism of action and defined health benefits as required to meet the prebiotic definition. Prebiotics are part of a food industry with increasing market sales, yet there are great disparities in regulations in different countries. Identification and commercialization of new prebiotics with unique health benefits means that regulation must improve and remain up-to-date so as not to risk stifling research with potential health benefits for humans and other animals.

    SIGNIFICANCE AND IMPACT OF STUDY: This summary of the workshop discussions indicates potential avenues for expanding the range of prebiotic substrates, delivery methods to enhance health benefits for the end consumer and guidance to better elucidate their activities in human studies.

    Matched MeSH terms: Food Industry/legislation & jurisprudence
  11. Subin TS, Vijayan V, Kumar KJR
    Pharm Nanotechnol, 2017;5(3):180-191.
    PMID: 28641516 DOI: 10.2174/2211738505666170615095542
    BACKGROUND: Nanomedicine is a branch which deals with medicinal products, devices, nonbiological complex drugs and antibody-nanoparticle conjugates and general health products that are manufactured using nanotechnology.

    OBJECTIVE: Nano-medicine provides the same efficacies as traditional medicines owing to their improved solubility and bioavailability with reduced dosages. However, there are currently safety concerns due to the difficulties related to nanomaterial characterization; this might be the reason for unawareness of such medicines among the patients. The absence of clear regulatory guidelines further complicates matters, as it makes the path to registering them with regulatory bodies difficult. However, some products have overcome these obstacles and have been registered. While there are many international initiatives to harmonize the regulatory requirements and helps the industry to determine the most important characteristics that influence in vivo product performance.

    CONCLUSION: This review focuses on the various types of nanopharmaceuticals, and developments process with strategies tailored to upcoming regulations may satisfy the patients' needs.

    Matched MeSH terms: Drug Industry/legislation & jurisprudence
  12. Ng S, Sacks G, Kelly B, Yeatman H, Robinson E, Swinburn B, et al.
    Global Health, 2020 04 17;16(1):35.
    PMID: 32303243 DOI: 10.1186/s12992-020-00560-9
    BACKGROUND: The aim of this study was to assess the commitments of food companies in Malaysia to improving population nutrition using the Business Impact Assessment on population nutrition and obesity (BIA-Obesity) tool and process, and proposing recommendations for industry action in line with government priorities and international norms.

    METHODS: BIA-Obesity good practice indicators for food industry commitments across a range of domains (n = 6) were adapted to the Malaysian context. Euromonitor market share data was used to identify major food and non-alcoholic beverage manufacturers (n = 22), quick service restaurants (5), and retailers (6) for inclusion in the assessment. Evidence of commitments, including from national and international entities, were compiled from publicly available information for each company published between 2014 and 2017. Companies were invited to review their gathered evidence and provide further information wherever available. A qualified Expert Panel (≥5 members for each domain) assessed commitments and disclosures collected against the BIA-Obesity scoring criteria. Weighted scores across domains were added and the derived percentage was used to rank companies. A Review Panel, comprising of the Expert Panel and additional government officials (n = 13), then formulated recommendations.

    RESULTS: Of the 33 selected companies, 6 participating companies agreed to provide more information. The median overall BIA-Obesity score was 11% across food industry sectors with only 8/33 companies achieving a score of > 25%. Participating (p 

    Matched MeSH terms: Food Industry/legislation & jurisprudence
  13. McDaniel PA, Solomon G, Malone RE
    Environ Health Perspect, 2005 Dec;113(12):1659-65.
    PMID: 16330343
    Tobacco is a heavily pesticide-dependent crop. Because pesticides involve human safety and health issues, they are regulated nationally and internationally; however, little is known about how tobacco companies respond to regulatory pressures regarding pesticides. In this study we analyzed internal tobacco industry documents to describe industry activities aimed at influencing pesticide regulations. We used a case study approach based on examination of approximately 2,000 internal company documents and 3,885 pages of U.S. Environmental Protection Agency documents obtained through Freedom of Information Act requests. The cases involved methoprene, the ethylene bisdithiocarbamates, and phosphine. We show how the tobacco industry successfully altered the outcome in two cases by hiring ex-agency scientists to write reports favorable to industry positions regarding pesticide regulations for national (U.S. Environmental Protection Agency) and international (World Health Organization) regulatory bodies. We also show how the industry worked to forestall tobacco pesticide regulation by attempting to self-regulate in Europe, and how Philip Morris encouraged a pesticide manufacturer to apply for higher tolerance levels in Malaysia and Europe while keeping tobacco industry interest a secret from government regulators. This study suggests that the tobacco industry is able to exert considerable influence over the pesticide regulatory process and that increased scrutiny of this process and protection of the public interest in pesticide regulation may be warranted.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence*
  14. Tan YL, Foong K
    Tob Control, 2012 Jan;21(1):55-6.
    PMID: 21803928 DOI: 10.1136/tc.2011.042713
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence*
  15. Sirichotiratana N, Sovann S, Aditama TY, Krishnan M, Kyaing NN, Miguel-Baquilod M, et al.
    Tob Control, 2008 Dec;17(6):372-8.
    PMID: 18669557 DOI: 10.1136/tc.2007.024190
    The Association of Southeast Asian Nations (ASEAN) has made tobacco use prevention a primary health issue. All ASEAN countries except Indonesia have ratified the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), the world's first public health treaty on tobacco control.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence
  16. Barraclough S, Morrow M
    Soc Sci Med, 2008 Apr;66(8):1784-96.
    PMID: 18304713 DOI: 10.1016/j.socscimed.2008.01.001
    In the wake of the World Health Organization Framework Convention on Tobacco Control, corporate social responsibility (CSR) is among the few remaining mechanisms for tobacco corporations publicly to promote their interests. Health advocates may be unaware of the scale, nature and implications of tobacco industry CSR. This investigation aimed to construct a typology of tobacco industry CSR through a case study of the evolution and impact of CSR activities of a particular tobacco corporation in one country - British American Tobacco, Malaysia (BATM), the Malaysian market leader. Methods included searching, compiling and critically appraising publicly available materials from British American Tobacco, BATM, published literature and other sources. The study examined BATM's CSR strategy, the issues which it raises, consequences for tobacco control and potential responses by health advocates. The investigation found that BATM's CSR activities included assistance to tobacco growers, charitable donations, scholarships, involvement in anti-smuggling measures, 'youth smoking prevention' programs and annual Social Reports. BATM has stated that its model is predominantly motivated by social and stakeholder obligations. Its CSR activities have, however, had the additional benefits of contributing to a favourable image, deflecting criticism and establishing a modus vivendi with regulators that assists BATM's continued operations and profitability. It is imperative that health advocates highlight the potential conflicts inherent in such arrangements and develop strategies to address the concerns raised.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence
  17. Yong HH, Borland R, Hammond D, Sirirassamee B, Ritthiphakdee B, Awang R, et al.
    Tob Control, 2008 Feb;17(1):46-52.
    PMID: 18218808 DOI: 10.1136/tc.2007.021964
    To examine the impact of tobacco advertising policy on adult smokers' awareness of tobacco promotion in two developing countries--Malaysia and Thailand.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence
  18. Cressey D
    Nature, 2015 May 28;521(7553):401-2.
    PMID: 26017420 DOI: 10.1038/521401a
    Matched MeSH terms: Drug Industry/legislation & jurisprudence
  19. Morrow M, Barraclough S
    Health Promot Int, 2003 Sep;18(3):255-64.
    PMID: 12920146 DOI: 10.1093/heapro/dag021
    In the World Health Organization's Western Pacific Region, being born male is the single greatest risk marker for tobacco use. While the literature demonstrates that risks associated with tobacco use may vary according to sex, gender refers to the socially determined roles and responsibilities of men and women, who initiate, continue and quit using tobacco for complex and often different reasons. Cigarette advertising frequently appeals to gender roles. Yet tobacco control policy tends to be gender-blind. Using a broad gender-sensitivity framework, this contradiction is explored in four Western Pacific countries. Part I of the study discusses issues surrounding gender and tobacco, and analyses developments in Malaysia and the Philippines. Part II deals with Singapore and Vietnam. In all four countries, gender was salient for the initiation and maintenance of smoking, and in Malaysia and the Philippines was highly significant in cigarette promotion. Yet, with a few exceptions, gender was largely unrecognized in control policy. Suggestions for overcoming this weakness in order to enhance tobacco control are made in Part II.
    Study name: National Health and Morbidity Survey (NHMS-2006)
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence*
  20. Morrow M, Barraclough S
    Health Promot Int, 2003 Dec;18(4):373-80.
    PMID: 14695368
    In the World Health Organization's Western Pacific Region, being born male is the single greatest risk marker for tobacco use. While the literature demonstrates that risks associated with tobacco use may vary according to sex, gender refers to the socially determined roles and responsibilities of men and women, who initiate, continue and quit using tobacco for complex and often different reasons. Cigarette advertising frequently appeals to gender roles. Yet tobacco control policy tends to be gender-blind. Using a broad, gender-sensitivity framework, this contradiction is explored in four Western Pacific countries. Part I of the study presented the rationale, methodology and design of the study, discussed issues surrounding gender and tobacco, and analysed developments in Malaysia and the Philippines (see the previous issue of this journal). Part II deals with Singapore and Vietnam. In all four countries gender was salient for the initiation and maintenance of smoking. Yet, with a few exceptions, gender was largely unrecognized in control policy. Suggestions for overcoming this weakness in order to enhance tobacco control are made.
    Matched MeSH terms: Tobacco Industry/legislation & jurisprudence*
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