Tobacco Control Strategies Enrich the National Strategic Plan on Prevention and Control of Cancer in Sri Lanka.

The National Cancer Control Programme Sri Lanka is the main government organization and focal point for coordinating the national response to prevention and control of cancer activities. Present National strategic plan on Cancer Prevention and Control (2020-2024) was developed by multi-sectoral expert groups. The present strategy derives its mandate from the overarching National policy documents including the NATA Act. Strategic objectives one and two of the National Strategic Plan identified the tobacco control measures. Several databases were searched to find out the relevant literature relevant to tobacco control strategies in Sri Lanka and the rest was collected from the university libraries, experts, and key persons in the field from the legal, and health sectors. It was identified more than 200 documents relevant to tobacco control. Strong legal legislations are available for measures to reduce the demand for tobacco products. Those are Protection from exposure to tobacco smoke, regulation of the contents of tobacco products, regulation of tobacco product disclosures, packaging and labeling of tobacco products, tobacco advertising, promotion and sponsorship, licit trade in tobacco products, sales to under 21, Provision of support for economically viable alternative activities. These legislations are covering by the NATA act. New formula for tobacco taxation was submitted to the Ministry of Health. Conclusion: Strong tobacco controlling laws and legislations are available in Sri Lanka that supports achieving one and two of the strategic objectives of the National strategic plan on cancer prevention and control in Sri Lanka. Policies are needed to regularize the increased tax rates to adjust for inflation and Gross Domestic Product. WHO has categorized Sri Lanka as one of the countries which can likely achieve a decrease in tobacco smoking prevalence (30%) by 2025.

Implementation of MPOWER Package in the South-East Asia Region: Evidence from the WHO Report on the Global Tobacco Epidemic (2009-2021).

The WHO MPOWER package is a set of six evidence-based and cost-effective measures which was introduced on 7 February 2008 to facilitate the implementation of the provisions of the WHO Framework Convention on Tobacco Control at the ground level. These measures are: Monitoring tobacco use and prevention policies (M); Protecting people from tobacco smoke (P); Offering help to quit tobacco use (O); Warning about the dangers of tobacco (W); Enforcing bans on tobacco advertising, promotion and sponsorship (E); and Raising taxes on tobacco (R). Since its launch, the MPOWER package has become the guiding principle for all the countries of the South-East Asia Region in their crusade against the tobacco epidemic. This review article tracks the implementation of the MPOWER measures in the 11 member countries of the Region based on the last seven WHO Report on the Global Tobacco Epidemic (GTCR), i.e., GTCR2/2009-GTCR8/2021. This is with an aim to enable the countries to review their progress in implementing the MPOWER measures and to take steps to improve their advancement towards reducing the demand for tobacco products at the country level.

From Pharmacology Research, to Pharmacology Regulation, and Back-as Inspired by the Teachings of Dr. Gavril Pasternak.

Dr. Gavril Pasternak, M.D., Ph.D. was an inspiration to many of his students, including myself. It was with great sadness that I learned about the passing of Dr. Gavril Pasternak in February 2019 after his brief battle with pancreatic cancer. I worked with Dr. Pasternak while I was an undergraduate chemistry student and as one of his technicians, collaborating with Dr. Charles Inturrisi and Dr. Eliot F. Hahn on opiate agonists and antagonists for opioid receptor subtypes. Dr. Pasternak inspired me and set me on the road to a career in pharmacology and encouraged me to pursue the fruitful paradigm of moving therapeutics from bench to bedside.

Análisis del cumplimiento del plan de consumo de los medicamentos de alto costo. Matanzas. 2012-2017 / Analysis of the fulfillment of the consumption plan of high cost medications. Matanzas. 2012 - 2017

RESUMEN Introducción: los medicamentos de alto costo son medicamentos nuevos, altamente específicos y utilizados en condiciones clínicas complejas, como el tratamiento de algunos tipos de cáncer; enfermedades que comprometen el sistema inmunológico, enfermedades inflamatorias o infecciosas. Objetivo: determinar cumplimiento del plan de consumo de los medicamentos de alto costo en la provincia de Matanzas, en el quinquenio 2012-2017. Materiales y métodos: estudio descriptivo, observacional de seguimiento sobre el cumplimiento del plan de consumo de los medicamentos de alto costo, en la población matancera del año 2012 al 2017. Se analizó el universo de medicamentos incluidos en esta categoría, a partir de la base de datos de suministro de medicamentos que emplea la Empresa Comercializadora de Medicamentos. Se identificaron las variables estudiadas. Resultados: en todo el período de estudio se observó un incremento creciente de los medicamentos de alto costo, en el 88,9 % de ellos el consumo ha estado por encima de la planificación realizada por la provincia. Los costos se incrementaron en un 233 % y además en las prescripciones realizadas de estos productos, se encontraron problemas como escaques vacíos, antibióticos sin impresión diagnóstica y omisión de la forma de presentación del medicamento y/o dosis indicada. Conclusiones: el consumo de muchos medicamentos de alto costo fue mayor que la planificación realizada en la provincia de Matanzas, durante el período analizado. Implicó un incremento significativo del presupuesto destinado a estos fines y se detectaron dificultades en el cumplimiento de lo establecido en las prescripciones de dichos medicamentos (AU).

ABSTRACT Introduction: high cost medications (HCM) are new highly specific medications and used in complex clinical conditions as in treatment of some types of cancer, diseases that compromise the immunological system, inflammatory or infections disorders. Objective: to determine the fulfillment of the consumption plan of high-cost medications in the province of Matanzas in the period 2012-2017. Materials and methods: a descriptive, observational, follow up study on the fulfillment of the consumption plan of high-cost medication by the population of Matanzas2012 year to 2017. The universe of drugs included in this category was analyzed on the bases of the drug-supplying database used by the Drug Commercializing Enterprise (ENCOMED in Spanish). The studied variables were identified. Results: it was observed a growing increase of high-cost drugs use during all the period; in 88.9 % of them the consumption has been above the planning made in the province. The costs increased in 233 %, and besides that in the prescriptions made of these drugs there were found problems like empty boxes, antibiotics without diagnostic impression and omissions of the drug presentation forms and/or the prescribed doses. Conclusions: the consumption of many high-cost drugs was higher than the planning made in the province of Matanzas for the analyzed period. It implied a significant increase of the budget destined for these aims and difficulties were found in the fulfillment of the terms for prescribing these drugs (AU).

Políticas de prevenção ao abuso de drogas no Brasil e nos Estados Unidos / Políticas de prevención para evitar el consumo de drogas en Brasil y Estados Unidos / Public policies for drug abuse prevention in Brazil and the United States

O objetivo deste estudo foi discutir as políticas públicas de prevenção ao abuso de drogas destinadas aos jovens no Brasil e nos Estados Unidos. A formulação dessa política no Brasil tem-se estabelecido a partir de programas que são questionados internacionalmente em termos epistemológicos, teóricos e metodológicos. Conclui-se que a construção de políticas sociais na América Latina permanece atravessada pela manutenção da dependência aos países centrais, uma vez que as tensões entre os modelos proibicionista e de redução de danos se mantêm entre o que preveem as políticas de prevenção ao abuso de drogas da Secretaria Nacional de Políticas sobre Drogas e do Ministério da Saúde e o que de fato é executado. Sugere-se buscar autonomia em relação aos modelos de ações preventivas impostos pelos países dominantes, por meio de um debate mais amplo entre pesquisadores, profissionais, usuários e movimentos sociais para o protagonismo de políticas mais adequadas ao Brasil.

El objetivo de este estudio fue discutir las políticas públicas de prevención del consumo de drogas destinadas a jóvenes en Brasil y Estados Unidos. La formulación de estas políticas en Brasil se ha establecido a partir de programas que son cuestionados internacionalmente, en términos epistemológicos, teóricos y metodológicos. Se concluye que la construcción de políticas sociales en Latinoamérica permanece influenciada por la continua dependencia de los países más importantes, ya que las tensiones entre los modelos prohibicionista y de reducción de daños se mantienen entre lo que prevén las políticas de prevención contra el consumo de drogas de la Secretaría Nacional de Políticas sobre Drogas y del Ministerio de Salud, y lo que de hecho se ejecuta. Se sugiere buscar autonomía respecto a los modelos de acciones preventivas, impuestos por parte de los países dominantes, mediante un debate más amplio entre investigadores, profesionales, consumidores y movimientos sociales para el protagonismo de políticas más adecuadas en Brasil.

The study's objective was to discuss public policies for drug abuse prevention targeted to young people in Brazil and the United States. Brazil has formulated its policy with programs that are questioned at the international level on epistemological, theoretical, and methodological grounds. The authors conclude that social policymaking in Latin America is still permeated by dependence on central countries, since the tension between the prohibitionist and harm reduction policies persists in the policy provisions for drug abuse prevention under the National Secretariat for Drug Policies and the Ministry of Health and what is actually implemented. The article suggests pursuing autonomy vis-à-vis the models for preventive measures imposed by the dominant countries, through a wider debate between researchers, health professionals, users, and social movements in the leadership of more appropriate policies for Brazil.

Serviços farmacêuticos na atenção primária à saúde: Estudo etnográfico em serviços de saúde no município de São Paulo / Pharmaceutical Services in Primary Health Care: Ethnographic Study in Health Services in the City of São Paulo

Os serviços farmacêuticos na Atenção Primária a Saúde (APS) é um tema emergente ao se tratar do contexto de desenvolvimento das políticas farmacêuticas no Brasil, em especial a de Assistência Farmacêutica. Na área, inúmeros estudos têm sido publicados e diversos grupos e instituições debatem o assunto, porém, sem um único consenso ou modelo propositivo. A APS ou Atenção Básica é o modelo de atenção prioritário adotado no Brasil, no SUS e tem como características a territorialização, o trabalho em equipe multiprofissional, o vínculo e o acolhimento. É um espaço rico de desenvolvimento de serviços farmacêuticos e de viabilidade das estratégias de garantia do direito à saúde, como o acesso a medicamentos essenciais e cuidado no seu uso. Por isso a farmácia na APS é um local de trabalho do farmacêutico, com boa empregabilidade e possibilidade de desenvolvimento de uma atuação não tão ligada a histórica formação do farmacêutico tecnicista. Além disso, é preciso desenvolver reflexões sobre serviços farmacêuticos utilizando dados da realidade, possibilitando que estudos como este possam contribuir no desenvolvimento de serviços na APS a partir das necessidades em saúde, considerando as determinações sociais do processo saúde-doença. Sendo assim, o objetivo desta tese foi o de caracterizar os serviços farmacêuticos na Atenção Primária à Saúde, no município de São Paulo, e como se expressam em diferentes modelos na materialidade da APS. Utilizou-se a pesquisa qualitativa, especificamente a Observação Participante, com abordagem etnográfica como fonte para o aprofundamento do conhecimento, pois permite a compreensão do homem em sua sociabilidade. O estudo foi desenvolvido no município de São Paulo. A primeira parte corresponde a um estudo exploratório, composto por um grupo focal com 20 farmacêuticos e um survey online aplicado a outros 120 farmacêuticos. Todos atuam na Secretaria Municipal de Saúde. Na segunda parte, o estudo foi desenvolvido em 3 Unidades Básicas de Saúde, com aproximadamente 170 horas de observação, registradas em cadernos de campo. Os registros possibilitaram a análise e a formação de categorias conceituais. Por fim, a APS permite uma construção e visão ampliadas do escopo dos serviços farmacêuticos, ao analisá-los a partir da percepção de quem os vive, uma vez que há o entendimento de que os serviços não são fragmentados e que o farmacêutico os executa em um campo complexo, ampliado e dinâmico como a APS. O uso da Observação Participante em estudos na área da saúde, especialmente na Farmácia, possibilita reflexões sobre o fenômeno, que não são isoladas, nem mesmo descontextualizadas da realidade em saúde. Identifica-se a necessidade de estudos qualitativos para a descrição interpretativa dos fenômenos na saúde apoiada nas ciências humanas, (re)fazendo movimentos de síntese críticos e reflexivos. Procedentes da análise, pode-se na observação participante compreender três modelos diferentes de atuação do farmacêutico, que geram concepções de serviços farmacêuticos distintas e que se relacionam aos modelos de APS, sendo alguns mais universais e integrais versus modelos de cobertura universal, focalizados e seletivos. Os serviços farmacêuticos na APS têm um potencial de compreender que as pessoas não são iguais por completo, e que é preciso reconhecer as necessidades e, por conseguinte, sociais. As evidências obtidas foram demonstradas em categorias conceituais relacionadas às diferentes perspectivas dos serviços farmacêuticos na APS, possibilitando entender que o farmacêutico é a referência em medicamentos nas UBS e tem-se feito essencial para a população, especialmente no campo da APS. Tendo nessa perspectiva uma nova prática, aquela que é real, construída pela prática da APS, e não em métodos teóricos de atendimento clínico. Os serviços farmacêuticos que se estabelecem na APS devem contribuir com as condições de vida, permeados pelo debate das determinações sociais de saúde, sendo necessário refletir sobre quais necessidades, àquelas vigentes e de acordo com o que o mercado deseja ou àquelas que correspondem as necessidades reais

Pharmaceutical services in Primary Health Care (PHC) is an emerging concept in the context of developing pharmaceutical policies in Brazil, especially Pharmaceutical Assistance. Numerous studies in this field have been published and several groups and institutions debate the subject; however, there is no consensus on the proposed model. PHC or Basic Care is the preferred model adopted in Brazil, in the Single Health System (SHS), and is characterized by territorialization, multiprofessional teamwork, relationships, and user embracement. It is a rich space for the development of pharmaceutical services and viable strategies for ensuring the right to health, including access to essential medicines and care in their use. That is why the pharmacy in PHC is a pharmacist's place of work, with good employability, and the possibility of developing an activity that goes beyond the traditional scope f a technical pharmacist. In addition, it is necessary to examine pharmaceutical services using actual data, enabling studies such as this to contribute to the development of PHC services based on health needs, considering the social determinants of the health-disease process. Thus, the objective of this thesis was to characterize the pharmaceutical services in PHC, in the city of São Paulo, and examine how they are expressed in different models in the materiality of PHC. We used qualitative research, specifically participant observation, with an ethnographic approach, to obtain in-depth knowledge, since it allows the understanding of man in his social context. The study was conducted in the city of São Paulo. The first part consists of an exploratory study, on a focus group with 20 pharmacists, and an online survey of another 120 pharmacists. They all work at the Municipal Health Office. The second part of the study was conducted in three Basic Health Units (BHU), with approximately 170 hours of observation recorded in field notebooks. The records made it possible to analyze and form conceptual categories. Finally, PHC allows a broader construct and vision of the scope of pharmaceutical services, by analyzing them from the perception of those who experience them, since there is an understanding that the services are not fragmented and that the pharmacist performs them in a complex, expanded, and dynamic field, like PHC. The use of participant observation in health field studies, especially in Pharmacy, allows reflections on the phenomenon, which are not isolated, nor decontextualized from the reality in health. The need for qualitative studies is felt for the interpretative description of health phenomena supported by the human sciences, (re)making critical and reflective synthesis movements., By using participant observation in the analysis, it is possible to understand three different models of the pharmacist's performance, which lead to distinct conceptions of pharmaceutical services and are related to PHC models, some of them more universal and integral compared to universal coverage models that are focused and selective. The pharmaceutical services in PHC have the potential to understand that people are not completely the same, and that it is necessary to recognize the needs, and therefore the social conditions. The evidence obtained has been demonstrated in conceptual categories related to the different perspectives of pharmaceutical services in PHC, making it possible to understand that the pharmacist is the authority in medicines at the Health Care Unit and has become essential for the population, especially in the field of PHC. This perspective comprises a new approach, one that is realistic and practical, built by the practice of PHC, and not based on theoretical methods of clinical care. The pharmaceutical services established in PHC must contribute to living conditions, accompanied by the debate on social health determinations, and it is necessary to reflect on which are the needs that are in force and according to what the market wants or those that correspond to real necessities

Determining the Comparative Value of Pharmaceutical Risk-Sharing Policies in Non-Small Cell Lung Cancer Using Real-World Data.

BACKGROUND: Risk-sharing arrangements (RSAs) can be used to mitigate uncertainty about the value of a drug by sharing the financial risk between payer and pharmaceutical company. We evaluated the projected impact of alternative RSAs for non-small cell lung cancer (NSCLC) therapies based on real-world data. METHODS: Data on treatment patterns of Dutch NSCLC patients from four different hospitals were used to perform "what-if" analyses, evaluating the costs and benefits likely associated with various RSAs. In the scenarios, drug costs or refunds were based on response evaluation criteria in solid tumors (RECIST) response, survival compared to the pivotal trial, treatment duration, or a fixed cost per patient. Analyses were done for erlotinib, gemcitabine/cisplatin, and pemetrexed/platinum for metastatic NSCLC, and gemcitabine/cisplatin, pemetrexed/cisplatin, and vinorelbine/cisplatin for nonmetastatic NSCLC. RESULTS: Money-back guarantees led to moderate cost reductions to the payer. For conditional treatment continuation schemes, costs and outcomes associated with the different treatments were dispersed. When price was linked to the outcome, the payer's drug costs reduced by 2.5% to 26.7%. Discounted treatment initiation schemes yielded large cost reductions. Utilization caps mainly reduced the costs of erlotinib treatment (by 16%). Given a fixed cost per patient based on projected average use of the drug, risk sharing was unfavorable to the payer because of the lower than projected use. The impact of RSAs on a national scale was dispersed. CONCLUSIONS: For erlotinib and pemetrexed/platinum, large cost reductions were observed with risk sharing. RSAs can mitigate uncertainty around the incremental cost-effectiveness or budget impact of drugs, but only when the type of arrangement matches the setting and type of uncertainty.

Role of Health Technology Assessment in Drug Policies: Korea.

South Korea is the first Asian country to mandate the submission of pharmacoeconomic data for reimbursement decision making. For a new drug to be listed, it must demonstrate its value in terms of comparative effectiveness and cost effectiveness. The Health Insurance Review and Assessment Service (HIRA) judges the submitted drug's value and decides whether its coverage is appropriate on the basis of the recommendation of the Pharmaceutical Benefit Coverage Assessment Committee. Once the drug has been accepted by HIRA, the National Health Insurance Service and the sponsoring company negotiate the price and expected sales volume. Even if HIRA acknowledges the value of the drug, it cannot be listed if the negotiation fails. In the off-patent market, generic and original branded drugs are treated equally in terms of pricing. Once generics enter the market, both drug prices should be lowered to 53.55% or less of the on-patent price. Since the current system was implemented, concerns have been raised about a decline in the accessibility of new drugs, especially for high-priced drugs used to treat serious diseases. In 2013, several measures had been introduced aimed at improving the accessibility of these drugs. A risk-sharing scheme and an increase in the maximum acceptable cost-effectiveness ratio were subsequently initiated. Although these schemes have been successful in improving access to high-priced drugs, they are often criticized for reducing transparency in pricing. Finding a balance between accessibility and efficiency is still a challenge in Korea.

Public support for tobacco control policies: The role of the protection of children against tobacco.

INTRODUCTION: In many countries, health advocates aim to increase public support for tobacco control policies by framing these policies in terms of child protection. We examined whether support for the protection of children is indeed associated with support for tobacco control policies, even among smokers, opponents of state intervention and opponents of a governmental role in tobacco control. METHODS: We used a survey on a representative sample of Dutch adults of 18 years and older (n = 1631). The survey measured respondents' support for banning tobacco displays, raising the age of sale for tobacco to 21 years and limiting tobacco sales to specialized shops. Regression analyses were done to assess the association with respondents' support for the protection of children against tobacco. In further analyses, subgroup interactions were added. RESULTS: Respondents' support for the protection of children against tobacco with legislation was positively related to support for all three policies. Associations were weaker for smokers (except for raising the age of sale) but similar for opponents of state intervention and opponents of a governmental role in tobacco control. CONCLUSION: This is the first paper to empirically support the idea that emphasizing the need to protect children against tobacco enhances support for tobacco control policies. This 'child effect' is effective in all segments of the population, albeit somewhat weaker among smokers.

Could cannabis liberalisation lead to wider changes in drug policies and outcomes?

Cannabis policies are changing in some countries. This may have consequences that extend beyond cannabis-specific outcomes, such as an impact on the consumption patterns of other substances. Changes in cannabis policies may also influence policy responses to other drugs, as countries re-assess the balance between law enforcement and public health objectives. If this happens, it could have important health and social consequences, especially in those countries where a 'war on drugs' policy perspective has inhibited investment in evidence based responses in areas such as treatment and harm reduction. The burden of disease associated with opioid use for example is large and this is an area in which treatment and harm reduction have been shown to deliver benefits. Thus if the changes in cannabis policies result in a greater willingness to invest in effective interventions for other drugs, the potential net health gains could be considerable. On the other hand, if cannabis policy changes are associated with an increase in health risk behaviours, such as driving under the influence or increased use of harmful substances such as tobacco, then significant increased health costs could result. To date most attention has been focused on recent cannabis sales liberalisation in the Americas, but experiences from elsewhere are also informative. In Europe, for example, moves towards decriminalisation of drug possession are resulting in lower rates of incarceration and arguably have reduced barriers to treatment uptake. Robust monitoring and assessment of the impact of these different policy changes is crucial to evaluating and understanding their results. It is important that such monitoring is international in scope, is not limited to issues around the use of cannabis only, and considers the interactions that may exist between cannabis policies and the approaches taken to other substances.

A cross-sectional national survey assessing self-reported drug intake behavior, contact with the primary sector and drug treatment among service users of Danish drug consumption rooms.

BACKGROUND: Drug consumption rooms (DCRs) have been implemented worldwide as a harm-reducing strategy. In 2012, Denmark passed legislation allowing establishment of DCRs. The aim of this study was to identify characteristics and gain knowledge of the way service users use the DCRs including bridge building to specialized health care. Associations between nationality, opioid substitution treatment (OST), drug intake method, and response to staff advice on harm-reducing education was investigated, as well as service user's reasons for using the DCRs, and their perceptions of safety and trust in the DCRs. METHODS: A survey questionnaire sampled 154 participants of DCRs. Convenience sampling was used. Key variables covered demographics, drug intake mode, educational advice received in the DCR, and opinions about and role of the DCRs for the service users. RESULTS: Only 10 % of the participants were under the age of 30, 30 % between 30 and 39 years, 36 % between 40 and 49 years, and 24 % age 50 or more. A total of 60 % of the participants had encountered drugs before they were 19 years old. Female participants were 25 %, and 73 % were Danish citizens, 8 % were non-Danish EU citizens, and 18 % were non-EU citizens. As drug intake method, 63 % injected drugs in a vein, 7 % sniffed, and 37 % smoked. Of drugs used in the DCR, 49 % used cocaine, 41 % heroin, 16 % a mix of heroin and cocaine, and 16 % used methadone. Participants who smoked drugs made significantly less use of drug rehabilitation than participants who sniffed or injected drugs. There was a similar rate of advice on OST across nationality. Participants accepted staff education on hygienic measures and safe injection practices and found it useful. Participants felt safe and trusted staff and bridge building to specialized health care took place in the DCR. CONCLUSIONS: Staff of Danish DCRs educate service users on health related issues and harm-reducing interventions. A subgroup who smoke and a subgroup of nationality other than Danish are underserved and have less likely been in OST. More research on these groups is needed.

[MEDICAL CANNABIS].

The cannabis plant has been known to humanity for centuries as a remedy for pain, diarrhea and inflammation. Current research is inspecting the use of cannabis for many diseases, including multiple sclerosis, epilepsy, dystonia, and chronic pain. In inflammatory conditions cannabinoids improve pain in rheumatoid arthritis and:pain and diarrhea in Crohn's disease. Despite their therapeutic potential, cannabinoids are not free of side effects including psychosis, anxiety, paranoia, dependence and abuse. Controlled clinical studies investigating the therapeutic potential of cannabis are few and small, whereas pressure for expanding cannabis use is increasing. Currently, as long as cannabis is classified as an illicit drug and until further controlled studies are performed, the use of medical cannabis should be limited to patients who failed conventional better established treatment.

Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.

The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan and the US Food and Drug Administration are responsible for reviewing applications and approving drugs, medical devices, and regenerative medicines. In the EU, the European Medicines Agency is responsible for the centralized authorization procedure of medicines including oncologic drugs. In this review, we discuss general pathways for the marketing authorization of oncologic drugs and other drugs in Japan, the EU, and the US. There are still unmet medical needs in oncology, whereas scientific innovation and clinical development in oncology are rapid and active, suggesting a reasonable scope for new regulatory schemes for expedited review. Because regulatory schemes are also evolving rapidly, clinicians and academic researchers may have difficulty following the updated regulations in other regions as well as those in their own countries. However, keeping current with new regulations is important for the conduct of translational research and clinical development of new therapeutic products efficiently. This review is intended to help an international audience better understand the essence of the regulatory frameworks for the marketing authorization of oncologic drugs in Japan, the EU, and the US.