Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.

The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication.

Advancing probiotic research in humans in the United States: Challenges and strategies.

This is a summary from a workshop convened as part of the 13(th) annual meeting of the International Scientific Association for Probiotics and Prebiotics. A group of 24 stakeholders, including clinical experts, researchers, federal government officials, funding agencies, lawyers and industry experts met to review the challenges of the current regulatory approach to human research on probiotics in the USA and to discuss ways to move research forward. There was agreement that some of the current regulatory requirements imposed on probiotic research in the United States hindered research progress and increased cost without improving study subject safety. Many situations were outlined by clinical investigators demonstrating the impact of regulatory delays on research progress. Additionally, research is compromised when study designs and outcomes require manipulation so as to invoke less burdensome regulatory requirements. These responses by investigators to regulatory requirements have placed United States' researchers at a disadvantage. The public ultimately suffer when research to clarify the role of these products on health is stalled. Workshop participants concurred that regulatory oversight should balance study subject vulnerability with documented safety for the intended use for the probiotic strain, and that human research on foods and supplements should not be be regulated as drug research. Challenges and potential improvement strategies are discussed.

[Official experimental testing of biomedical products. Regulatory frame and importance of for quality, safety and efficacy]. / Staatliche experimentelle Produktprüfung von biomedizinischen Arzneimitteln. Regulatorischer Rahmen und Bedeutung für die Qualität, Sicherheit und Wirksamkeit.

The official experimental testing of biomedicinal products provides a very significant contribution to ensuring quality, safety and efficacy of these indispensable medicines. Already in the prelicensing phase or to elucidate clusters of increased adverse effects, official medicinal control laboratories are committed to perform experimental testing. The official batch release can be seen as external quality control of the manufacturer's release testing. For proficient performance in these tasks, scientific research is required, in particular on the development and refinement of test methods, and considering the continuous development of innovative biomedicinal products. This article is aimed at introducing the present thematic issue and in particular the regulatory basis of experimental product testing, and illustrates by means of several examples its great importance for the sake of the patients.

Structure, control and regulation of the formal market for medicinal plants' products in Nigeria.

There are informal and formal markets for medicinal plants' products in Nigeria. The formal market is subject to the national regulatory framework for Food and Drug Administration and Control. It is relatively new and underdeveloped. This study was designed to appraise this market with special emphasis on the market participants, market structure, marketing functions performed, conduct of sellers in the market and; standards and regulations to which the market is subject. Information used for this study was collected through personal interviews and interactions with key participants in the market; especially the officials of regulatory agency. The market structure was analysed in terms of the share of market controlled by participants and product types. Concentration Ratios (CR2 and CR4) were used to assess the market share. Marketing functions being performed were described in terms of the exchange, physical and facilitating functions while the conduct was described in terms of pricing and promotional strategies. The regulatory framework under which the market operates was appraised. The market was highly concentrated with a CR2 and CR4 of 58.5% and 80.8 %; respectively. Imported products accounted for only 12.3% of the market. The predominant modes of presentation of the product were capsule (41.6%) and liquid (36.2%). About 20.77% of the products were classified as multivitamins, 13.85% were antibiotics while 10.77% addressed sexual dysfunctional problems. These products were regulated under the Food and Drug Administration and Control (NAFDAC) decrees, 1993-1999. Only 2.3% of the products have received full registration status while the others were only listed.

Sistemas de gestión de calidad en autoridades reguladoras de medicamentos: impacto social / Quality management systems in drugs regulatory authorities: social impact

El presente trabajo tiene como objetivo abordar el impacto que tiene sobre la sociedad el adecuado desempeño de las autoridades reguladoras de medicamentos a partir de la implementación de un sistema de gestión de calidad (SGC) en estas agencias. Para esto, previamente se muestra un análisis del entorno actual en la regulación de medicamentos y de la influencia de la calidad en los sistemas de salud, que han propiciado un incremento en los controles en este sentido.Se exponen los beneficios tanto para el desarrollo de la industria farmacéutica y biotecnológica como para la población, que recibe los productos de éstas, a través de un modelo que relaciona el desempeño de las autoridades reguladoras y el ciclo de mejora que se ilustra en un SGC. Finalmente, se presenta el caso de la autoridad reguladora cubana, que actualmente dispone de un SGC avalado por agencias certificadoras(AU)

The aim of this paper is to illustrate the social impact of drugs regulatory authorities’ procedures, viewed from the perspective of the implementation of a quality management system. A review of drug regulations and their influence on quality and health systems is described(AU)

The challenges of changing national malaria drug policy to artemisinin-based combinations in Kenya.

BACKGROUND: Sulphadoxine/sulphalene-pyrimethamine (SP) was adopted in Kenya as first line therapeutic for uncomplicated malaria in 1998. By the second half of 2003, there was convincing evidence that SP was failing and had to be replaced. Despite several descriptive investigations of policy change and implementation when countries moved from chloroquine to SP, the different constraints of moving to artemisinin-based combination therapy (ACT) in Africa are less well documented. METHODS: A narrative description of the process of anti-malarial drug policy change, financing and implementation in Kenya is assembled from discussions with stakeholders, reports, newspaper articles, minutes of meetings and email correspondence between actors in the policy change process. The narrative has been structured to capture the timing of events, the difficulties and hurdles faced and the resolutions reached to the final implementation of a new treatment policy. RESULTS: Following a recognition that SP was failing there was a rapid technical appraisal of available data and replacement options resulting in a decision to adopt artemether-lumefantrine (AL) as the recommended first-line therapy in Kenya, announced in April 2004. Funding requirements were approved by the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) and over 60 million US$ were agreed in principle in July 2004 to procure AL and implement the policy change. AL arrived in Kenya in May 2006, distribution to health facilities began in July 2006 coincidental with cascade in-service training in the revised national guidelines. Both training and drug distribution were almost complete by the end of 2006. The article examines why it took over 32 months from announcing a drug policy change to completing early implementation. Reasons included: lack of clarity on sustainable financing of an expensive therapeutic for a common disease, a delay in release of funding, a lack of comparative efficacy data between AL and amodiaquine-based alternatives, a poor dialogue with pharmaceutical companies with a national interest in antimalarial drug supply versus the single sourcing of AL and complex drug ordering, tendering and procurement procedures. CONCLUSION: Decisions to abandon failing monotherapy in favour of ACT for the treatment of malaria can be achieved relatively quickly. Future policy changes in Africa should be carefully prepared for a myriad of financial, political and legislative issues that might limit the rapid translation of drug policy change into action.

El Formulario Nacional Español / The Spanish National Formulary

Por fin apareció el Formulario Nacional, después de 18 años de anunciarlo la Ley General de Sanidad y de 15 de definirlo y regularlo la Ley del Medicamento. Por fin apareció y hay que celebrarlo y felicitar a cuantos han intervenido en el logro salvando las muchas dificultades con que han tropezado en su periplo. Ha aparecido como primer volumen del que ha de ser el instrumento básico de los farmacéuticos en su ejercicio profesional en la elaboración de medicamentos. Es un hito importante, no suficiente, que en líneas generales ha de considerarse muy satisfactorio, lo que no obsta para que hagamos de él un comentario extenso acompañado de una crítica constructiva y una propuesta de mejora

At last the Formulario Nacional (National Formulary) has been published, 18 years its announcement in the Ley General de Sanidad (Health General Act) and 15 years after its definition and regulation in the Ley del Medicamento (Medicines Act). At last it has been published and it should be celebrated, and we congratulate those who have taken part in the achievement, avoiding many difficulties along its long journey. It has been published as the first volume of what has to be the basic tool for the pharmacists in their professional exercise of making medicines. It is an important, but not sufficient, milestone, that in broad outline we regard very satisfactory, althrough we do an extensive comment together with a constructive review and a proposal of improvement

Avaliação da adequação da publicidade de produtos naturais anunciada na Paraíba / Accuracy of information on natural products advertised in Paraíba

Considerando-se a expansão crescente do uso e comercialização de produtos naturais nos últimos anos e a preocupação com a qualidade e segurança dos produtos anunciados na mídia, buscou-se avaliar a adequação de sua publicidade em relação à legislação vigente. Com este objetivo, foi feita a coleta de 135 peças publicitárias, anunciando 690 diferentes produtos, obtidas em cinco diferentes veículos de comunicação: impressos, revistas, jornais regionais, emissoras de TV e de rádio veiculadas no município de João Pessoa/PB, no período de outubro de 2002 a outubro de 2003. O conteúdo das peças publicitárias foi analisado, considerando-se a sua adequação a Resolução de Diretoria Colegiada (RDC) número 102/2000/ANVISA, que regula a publicidade de medicamentos. Foi observado que 97,04% das peças publicitárias anunciadas na Paraíba não se encontram coerentes com a legislação brasileira, podendo promover diversos danos aos seus usuários, como o uso indiscriminado de medicamentos, a automedicação e reações adversas

Desarrollo de los Estudios de Farmacia en Concepcion (Chile) / Edible higher fungi cultivation, a resource of inevitable development in the XXI century

No disponible

The regulatory situation in Trinidad and Tobago for trade in herbal medicinal products

The Chemistry/Food and Drugs Division, Ministry of Health is the government's monitoring and regulatory authority for the control, manufacture, importation, storage and disposal of food, drugs (pharmaceuticals), cosmetics, medical devices, pesticides and toxic chemicals. The Division is mandated to ensure that only safe and quality food, drugs, cosmetics and medical devices of an acceptable standard reach the consumers. The Division is also responsible for ensuring safety in use, proper management and acceptable standards for pesticides and toxic chemicals and providing technological and laboratory services in the areas of food, drugs, cosmetics, medical devices, pesticides and toxic chemicals. Through a system of inspection, registration, licensing and laboratory work the regulatory functions are achieved. Herbal products, including herbal food supplements, traditional herbal remedies and herbal medicines, which are offered for sale in Trinidad and Tobago clearly fall under the jurisdiction of the Chemistry/Food and Drugs Division (AU)