რეცეპტის ინსტიტუტის დანერგვის გამოწვევები საქართველოს ჯანდაცვის ინსტიტუციურ განვითარებაში

Drugs are marketed with generic and trade names. Our purpose was to study whether this dual name system causes problems to physicians. We interviewed 102 Finnish physicians to find out how well they recalled the composition of combination drugs, and connected the corresponding generic and trade names. The generic name of the given trade-names were known on average by 83% of the physicians who had recently prescribed them, but knowledge of the combination drugs was poor. When generic names were given, on average 9% of the physicians who had prescribed them could mention the corresponding trade names. A multitude of names causes information problems, with possible clinical consequences. From the information point of view, one naming system would be desirable.

INTRODUCTION. The lack of a unified approach to establishing generic (grouping) names, which must be specified for herbal medicinal products, presents a challenge to developers and manufacturers preparing registration dossiers, as well as to regulators reviewing their submissions.AIM. This study aimed to set forth common approaches to establishing generic names for herbal medicinal products based on studying the terminology used in different legal systems.DISCUSSION. The authors analysed the pharmaceutical terminology used for herbal medicinal products at national and supranational levels in the Russian Federation, the Eurasian Economic Union (EAEU), the Republic of Belarus, the European Union (EU), the United Kingdom, and the United States. This analysis revealed differences in the terminology used in the Russian Federation and the EAEU. For example, the definition of “herbal drugs” is more detailed in the EAEU documents than in the Russian documents, and the definitions of “herbal drug preparation” and “herbal medicinal product” are not the same as well. The authors analysed the approaches to generic naming of herbal medicinal products and detected some improperly formed generic names in the regulatory documentation and Russian State Register of Medicinal Products. In addition, the study revealed variability in generic names proposed by different manufacturers for medicinal products having the same trade name. The authors described the selection of generic names for herbal medicinal products, including fatty or essential oils and liquid or dry extracts. The authors touched upon generic naming of some types of source plants when the morphological group of the herbal drug or the name of the source plant is ambiguous, the Latin name and the Russian name of the herbal drug are inconsistent, or the Latin name of the resulting product or the morphological group of the herbal drug is erroneous. The authors systematised and unified approaches to generic naming of herbal medicinal products with due regard to the species of source plants, the morphological groups of herbal drugs, and the production technology and composition of herbal medicinal products. The authors analysed typical errors in establishing conventional and generic names for herbal drugs and herbal medicinal products associated with incorrectly identified morphological groups of herbal drugs, incorrect source plant names, mismatching structures of Latin and Russian names of herbal drugs, erroneous Latin names of the resulting products, or wrongly assigned morphological groups of herbal drugs.CONCLUSIONS. According to the analysis of the names of herbal drugs, herbal drug preparations, and herbal medicinal products used in the State Pharmacopoeia of the Russian Federation (editions XI–XV), the Pharmacopoeia of the EAEU, and the European Pharmacopoeia, the terminology of these legal systems is harmonised to a high degree. The alignment of terminology is the closest between the regulatory documents of the EAEU and the EU. The terms and names used in Russia need further unification. The results of this study can be used in Russian pharmacopoeial practice to develop regulatory documents, prepare registration dossiers, and conduct expert reviews of submissions for herbal medicinal products.

WPSAR Vol 2, No 4, 2011 | doi: 10.5365/wpsar.2011.2.4.008 www.wpro.who.int/wpsar 1 a Offi ce of Public Health Emergency Preparedness and Response, Health Science Division, Ministry of Health, Labour and Welfare of Japan Submitted: 20 October 2011; Published: 23 December 2011 doi: 10.5365/wpsar.2011.2.4.008 Public health response to the combined Great East Japan Earthquake, tsunami and nuclear power plant accident: perspective from the Ministry of Health, Labour and Welfare of Japan

Congenital AnomaliesVolume 57, Issue 2 p. 44-44 Message from the JTSFree Access Proposal for supplemental intake of folic acid to reduce the risk of neural tube defects First published: 07 March 2017 https://doi.org/10.1111/cga.12210Citations: 5AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL The Japanese Teratology Society releases the following message for reducing the birth of babies with neural tube defects (congenital defects in the brain and/or spinal cord). Women who are planning to get pregnant or those who may be pregnant are advised to reduce the risk of having a baby with such defects by taking 400 μg (0.4 mg) of supplementary folic acid per day from 4 weeks before impregnation through gestation week 12. We also suggest that women who are at a high risk, such as those having a neural tube defect patient within their family and those having delivered a baby with such defects previously, should take hospital consultation on folic acid intake because the risk of their next baby suffering from neural tube defects is relatively higher than usual. Neural tube defects (spina bifida, anencephaly and encephalocele) arise at around gestation week 6 (4 weeks after fertilization) to obstruct the normal development of the brain and spinal cord. Most patients with spina bifida need to receive medical treatment including a surgical treatment soon after birth and treatments for hydrocephaly, walking difficulties and/or excretion disturbances, which may be followed by continuous rehabilitation through their whole life. Babies with anencephaly hardly survive after birth and those having encephalocele may suffer from neurological disorders even if the mass on the brain is removed surgically. Epidemiological studies have shown that maternal intake of folic acid, a kind of water soluble vitamins, decreases the risk of neural tube defects. According to a British epidemiological study (MRC Vitamin Research Group 1991), treatment of women of the high risk group, who have had a baby with neural tube defects previously, with 4 mg/day of folic acid successfully reduced the incidence of these anomalies in the next pregnancy: the preventive efficiency was estimated to be 72%. Another study in China (Berry et al. 1999) also demonstrated similar preventive effects of folic acid supplementation in primiparas (women bearing their first child) at daily doses of 0.4 mg. The Japanese Ministry of Health and Welfare (MHW), the present Ministry of Health, Labor and Welfare (MHLW), announced in 2000 that women who are planning to get pregnant should take 0.4 mg/day of supplementary folic acid, in addition to well-balanced food containing 0.4 mg/day of folic acid (MHW 2000). Daily intake of folic acid at approximately 1 mg/day does not cause excess symptoms (MHLW 2014). However, the percentage of Japanese women who take folic acid supplement is only 10–20% (Kondo et al. 2013; Obara et al. 2016) and the incidence of neural tube defects in Japan has remained unreduced (International Clearinghouse for Birth Defects Serveilance and Research 2014, MHW 2000). The Japanese Teratology Society aims to contribute to the health and welfare of Japanese people by making efforts to prevent the birth of babies with congenital anomalies. References MRC Vitamin Study Research Group. 1991. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 338: 131– 137. Berry RJ, Li Z, Erickson JD. 1999. Prevention of neural-tube defects with folic acid in China. China-U.S. Collaborative Project for Neural Tube Defect Prevention. N Engl J Med 341: 1485– 1490. International Clearinghouse for Birth Defects Serveilance and Research (ICBDSR) (2014) ICBDSR Annual Report 2014 with data for 2012. http://www.icbdsr.org/filebank/documents/ar2005/Report2014.pdf Kondo A, Morota N, Ihara S. 2013. Risk factors for the occurrence of spina bifida (a case–control study) and the prevalence rate of spina bifida in Japan. Birth Defects Res A Clin Mol Teratol 97: 610– 615. Ministry of Health and Welfare (MHW) in Japan (2000) 12-Jibo no. 72 (in Japanese). http://www1.mhlw.go.jp/houdou/1212/h1228-1_18.html Ministry of Health, Labor and Welfare (MHLW) in Japan (2014) Dietary refference intakes for Japanese (in Japanese). https://www.icbdsr.org/filebank/documents/ar2005/Report2014.pdf Obara T, Nishigori H, Nishigori T. 2016. Prevalence and determinants of inadequate use of folic acid supplementation in Japanese pregnant women: the Japan Environment and Children's Study (JECS). J Matern Fetal Neonatal Med 26: 1– 6. Citing Literature Volume57, Issue2March 2017Pages 44-44 ReferencesRelatedInformation

In a country like Portugal where life expectancy is very high, Health Promotion for Older People (HP4OP) is a relevant issue and specific strategies are considered within priority health programmes defined at the national level by the Directorate-General of Health on behalf of the Ministry of Health. The National Health Plan 2016–2020 includes directives to facilitate health promotion and access to health and social services, as well as to reduce the burden of chronic diseases. HP4OP funds and resources derive mainly from the Ministry of Health and also from the Ministry of Labour, Solidarity and Social Security. Moreover, institutions can access European and other funds to develop projects in this field and some municipalities also finance projects and initiatives. Health plans, strategies and programmes outlined at the national level are adopted by Regional Health Administrations and the Groups of Health Centres guide implementation at the local level through dedicated units that work within the primary health care context. The integration of both social and health actions in terms of HP4OP depends on collaboration between the Ministry of Health; the Ministry of Labour, Solidarity and Social Security; municipalities; institutions in the cooperative and social sector and other stakeholders such as families, educational institutions, religious communities and health professionals. As a whole, health promotion policies for the older people in Portugal tackle the social determinants of health too. Nevertheless, a systematic approach and an integrated strategy to tackle HP4OP might constitute an important condition for the full implementation of such policies. Additionally, fragmentation of initiatives at the regional and local levels, together with other barriers to addressing health promotion activities among health professionals, might lead to the non-homogeneous implementation of interventions of HP4OP throughout the country. It is expected that many of these constraints will be overcome with the launch and implementation of the intersectoral National Strategy for the Promotion of Active Ageing from 2017.

On April 24th, 2009, a new swine-origin influenza A (H1N1) was first reported in Mexico. Japan confirmed cases of the flu on May 9th, and the pandemic in Japan has become full-scale. The Ministry of Health, Labor and Welfare of Japan announced that the first peak of this pandemic was predicted to occur in October, 2009. Therefore, it is most important to predict the progress of this pandemic to be able to use medical resources effectively in Japan. We used a modified susceptible-exposed-infected-recovered (SEIR) model to calculate the number of infected people and hospital bed shortage during this pandemic. In this model, available medical resources were investigated on the basis of four vaccination scenarios. Our model showed that it would take a further six months for the pandemic to peak than was predicted by the Ministry of Health, Labor and Welfare of Japan. Without vaccination, at the peak of the pandemic 23,689 out of 400,000 people would be infected and the hospital bed shortage would reach 7,349 in total. We suggest that mathematical models are strong tools to predict the spread of infectious diseases. According to our model, it is possible to prevent hospital bed shortage by vaccination.

On July 30, 2003 the Revised Pharmaceutical Affairs Law and the Revised Transfusion Act were enacted by the Ministry of Health, Labor and Welfare to clarify the responsibilities of medical organizations. Taking this opportunity, the Hospital's Blood Transfusion Therapy Committee and Infection Control Committee undertook a review of methods of screening tests for post-transfusion infection. We decided to give patients a form letter to recommend they take a screening test for post-transfusion infection while providing notice to doctors that ‘2 months have passed since the transfusion (Blue Card)’. In addition, detailed discussions were held with respect to 1) test fees, 2) test criteria, 3) how to raise patients' awareness, and 4) how to enhance doctors' awareness. As a result, the use of screening tests for post-transfusion infection increased, from 6.8% to 54.6%, enabling us to confirm some effects. However, to fulfil our responsibilities to all patients receiving blood transfusion, the system for implementing this program requires urgent improvement. We thus aimed to further improve the system through operating the newly revised Blue Card system. In addition, it is necessary to create a system to ensure thorough implementation of the program with the electronic patient record due to commence in 2006.Meanwhile, the Ministry of Health, Labor and Welfare is expected to extend the application of patient assistance programs, in addition to implementing a system to ensure that patients receive safer blood transfusion.

The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law (PAL) and related ordinances. The Ministry of Health, Labour and Welfare (MHLW) is the governmental body responsible for enacting legislation for pharmaceutical affairs. The MHLW makes final decisions on whether it should halt trials for which investigational new drugs notifications (INDs) are submitted, and whether it should approve drugs for which New Drug Applications (NDAs) are submitted. The Pharmaceuticals and Medical Devices Agency (PMDA) is a semi‐governmental agency established by law that conducts scientific review of INDs and NDAs via internal review teams. The role of the PMDA as a review agency has become critical in pharmaceutical research and development activities, with recent progress in global regulatory harmonization and the necessity for cooperation between the regulator and the industry. The The PMDA also provides consultation services for clinical development, similar to those by the U.S. Food and Drug Administration. Historically, Japanese regulations have evolved by gradually accepting Western regulatory components into preexisting ones. Although most basic regulatory structures are similar to those in Western countries, there are still some obvious differences, including the applicability of INDs. Facing the recent decline in the numbers of domestic trials, the MHLW has issued several measures to promote domestic trials, including grants to train hospital staffs, but it is not expected that the decline will reverse easily because it is related to a diminishing demand for Japanese trials in response to the globalization of pharmaceutical research and development.

To the Editor: The Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations (2012) (1) was put into operation in January 2014. The act is summarized in Table 1. Generally, the government introduces legislation when a serious problem exists to be regulated (2). Fortunately for Japan, no serious accident has prevented the growth of allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, concerned parties such as physicians, patients and volunteers urged the legislature to regulate allo-HSCT. These parties expect the act to improve and maintain the infrastructure for allo-HSCT, especially regarding its financial aspects. Articles 28 and 42 stipulate that the government may provide partial subsidies, within budgetary limits, for the expenses of bone marrow, peripheral blood stem cell and cord blood supply to the agencies involved. However, these agencies must fully justify their operations due to their receipt of tax funds. Although the provision of unrelated sources is in public interest, the activity must be justified from a cost perspective (3). Safety is another issue. The act states that bone marrow and peripheral blood stem cell agencies and cord blood suppliers must be licensed by the Minister of Health, Labour and Welfare (Article 17 and 30). Article 32 also stipulates that cord blood suppliers must comply with the relevant standards specified by the Ministry of Health, Labour and Welfare ordinances in regard to how cord blood supply services are performed. Complying with these standards is necessary to ensure the safety and quality of the cord blood used in transplantation. This quality assurance is desirable for patients, but it requires additional manpower and facilities along with strengthened checking systems and record integrity. It may be necessary to meet the needs of higher quality to ensure the safety of allo-HSCT, just as the hemovigilance system is employed with blood transfusion (4). Government officials will likely focus most of their attention on regulation. However, allo-HSCT cannot be improved without research, and excessive regulation impedes medical development. Article 14 stipulates that the national government shall take necessary measures to encourage research and development that will contribute to promoting the appropriate provision of hematopoietic stem cells for use in transplantations, as well as the dissemination of the results of that research and development. Bone marrow, peripheral blood stem cell and cord blood suppliers should actively provide unrelated sources for researchers despite the regulations of the act. Government regulators should handle the authority of managing allo-HSCT. Under the government surveillance system, accidents due to systematic flaws can be prevented in advance. Also, these officials can take a comprehensive, panoramic view of allo-HSCT, which may have benefits such as the centralization of information management. However, highly specialized, constantly advancing field of allo-HSCT requires administrative officials to possess specialist knowledge and capabilities. A complete understanding of allo-HSCT is difficult to obtain without adequate practical experience. Therefore, the governmentmust encourage expert input or risk enacting rules that are out of touch with clinical practice. Since the act may directly affect the clinical practice of allo-HSCT, clinicians should understand its possible effects. A good thing for patients is that safe stem cell sources that meet the national standards can be provided for allo-HSCT all over Japan. On the other hand, tight control of sources, donors and patients, such as paper management, will be required in performing allo-HSCT. The pros and cons of the legislation are summarized in Table 2. The act may have both positive and negative impacts, but its benefits will be maximized if all parties play their own roles appropriately while understanding the act’s limitations. The views expressed are those of the author and do not necessarily reflect the policy of the Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare. Japanese Journal of Clinical Oncology, 2015, 1–2 doi: 10.1093/jjco/hyu225 Letter

In Japan, the elderly population has been rapidly increasing, and the “aging society” is currently considered one of the nation’s most important social concerns. According to statements by the Ministry of Health, Labour, and Welfare, the average life spans of men and women in 2008 were 79 and 86 years, respectively, and that of women in Japan is the longest in the world (Ministry of Health, Labour, and Welfare, 2009). The percentage of the elderly population in Japan will continue to increase. With the growing aging society, the number of elderly patients with various malignancies has been increasing. However, the rate of cancer in younger patients has also been increasing, due to changes in lifestyles, such as the increased popularity of Western food, viral infections, and genetic factors. In Japan, malignant neoplasms demonstrate the highest mortality rate, surpassing cerebrovascular and heart diseases since 1981, and lung cancer has demonstrated the highest mortality rate among every malignancy in both men and women.

Background According to the vital statistics report by the Ministry of Health, Labour and Welfare, the total number of deaths in Japan had decreased in 2020 (1,384,544) for the first time in 11 years, and underlying reasons include the decrease of approximately 16,000 deaths from respiratory diseases. The number of deaths subsequently increased in 2021 (1,439,809), and this increase was attributable in part to the outbreak of the Delta variant of the coronavirus disease 2019 (COVID-19). To the best of our knowledge, effects of the COVID-19 pandemic and the new normal of life with COVID-19 (e.g., avoiding crowds, wearing masks, and practicing hand hygiene) on the number of deaths from cardiovascular diseases, which have been the second leading cause of death in Japan, have not been studied thus far. Purpose To investigate the association between deaths from cardiovascular diseases and COVID-19 in Japan. Methods Data from the demographic survey conducted by the Ministry of Health, Labour and Welfare and analyzed, Japan was retrospectively analyzed. Results The number of deaths from cardiovascular diseases decreased in 2019 (207,714) and 2020 (205,596) when compared with those recorded in the previous year; however, the deaths started to increase again in 2021 (Fig 1.). Next, we analyzed deaths at ≥65 years of age. With reference to 2017, the rate of increase in the number of deaths in individuals aged ≥85 years was ≥10%, showing that the increased total number of deaths was due to the increase of deaths in those aged ≥85 years. Among causes of death, heart failure showed a particularly large increase. Deaths in other age groups showed almost no changes or decreases, except for deaths in individuals aged 70–74 years showing a ≥20% increase (Fig 2.). Thus, we looked into changes in the number of deaths in groups of individuals aged 65–69, 70–74, and 75–79 years. Deaths from acute myocardial infarction showed particularly large decreases in both ranges of 65–69 years and 75–79 years. As the number of deaths at 65–69 years of age tended to decrease, deaths from other heart diseases also decreased more or less. As the number of deaths at 75–79 years of age showed almost no changes, deaths from ischemic heart disease and heart failure increased slightly. In contrast to the data for the younger and older age groups, deaths at 70–74 years from almost all causes including acute myocardial infarction, heart failure, ischemic heart diseases, and arrhythmia increased in number. Conclusion The number of deaths from heart diseases decreased in 2020 compared to that in the prior year; however, the decrease was not fully explainable on the basis of the COVID-19 pandemic because deaths from heart diseases already tended to decrease in 2019. Furthermore, the number of deaths from heart diseases increased in people aged 70–74 years as well as those aged ≥85 years. The underlying reason is currently unknown; thus, continued monitoring is necessary.figure1figure2

In modern society, the quality and safety of food plays an important role. To ensure these significant indicators, it is necessary to create an effective system of state control. Such a system has been most successfully implemented in countries and associations such as the European Union, the United States of America and Japan. Successful attempts are also being made in Ukraine's neighboring countries to establish a system of coordination and control over the quality and safety of food products. In addition, many countries implemented sanitary control system based on HACCP and policy from farm to consumer and the system of rapid alerts on threats to food and animal feed. The European Union supervision of compliance requirements and standards, which aim to guarantee food safety engaged in the Ministry of Agriculture, Ministry of Social Affairs and the Ministry of Economic Affairs and Communications. The basic principles of regulating the system of compliance with the quality and safety of food are contained in the Law On Food, Regulation of the European Parliament and the EU Council №178 / 2002 EU. In the United States, food safety is monitored by a number of government agencies at various levels: federal, state, and local. At the federal level, 15 agencies collectively administer at least 30 food safety laws. In Japan, food safety is regulated by the Food Sanitation Act. According to the Act responsibility for ensuring safe food is shared by the Ministry of Health, Labor and Welfare and the Ministry of Agriculture, Forestry and Fisheries. In the Republic of Belarus, the main legal act in the field of food security is the Law On the quality and safety of raw materials and food for human life and health. Confirmation of the quality and safety of food products can be obtained at the Republican Unitary Enterprise Scientific and Practical Center of Hygiene. The National Agency for Food Safety has been established on the territory of the Republic of Moldova to effectively solve the tasks of ensuring and controlling the quality and safety of food products. It operates jointly with the Ministry of Health, Labor and Social Protection, the Ministry of Agriculture, Regional Development and the Environment, and the Ministry of Economy and Infrastructure.

BackgroundLicorice‐induced pseudoaldosteronism has been identified as a side effect of excessive licorice consumption. This condition is often characterized by hypertension, hypokalemia, and hyporeninemic hypoaldosteronism. If left untreated, this condition can lead to severe complications, such as arrhythmia and rhabdomyolysis, which can be life‐threatening. Thus, it is critical to recognize the early symptoms of pseudoaldosteronism to facilitate prompt intervention and effective management. Here, we investigated the frequency of various accompanying symptoms by systematically reviewing case reports of licorice‐induced pseudoaldosteronism not covered in similar studies and comparing findings with the manual on pseudoaldosteronism published by the Ministry of Health, Labour and Welfare (MHLW).MethodsA comprehensive search was conducted using MEDLINE/PubMed to gather relevant human studies published between 1960 and July 2023 and written in English; data focusing on accompanying symptoms were summarized.ResultsThirty‐seven pertinent articles, encompassing 48 case reports (26 females and 1 unreported sex, mean age 64.6 ± 14.6), were identified and scrutinized. The analysis revealed that hypertension was the most prevalent followed by weakness and edema. None of the researched cases reported instances of spasticity or rigidity.DiscussionThe study findings identified hypertension and weakness followed by edema as the predominant symptoms associated with pseudoaldosteronism which is in agreement with the MHLW manual. However, we doubt that spasticity, rigidity, and possibly numbness could be noticed by patients and their families as common initial symptoms outlined in the manual.

Introduction: In partnership with the Ministry of Health (MoH) and the Ministry of Labour and Social Protection (MoLSP), local public authorities, practitioners and civil society, NCD patients, formal and informal carers, Moldova is taking strides to ensure health and social services better meet the needs of vulnerable persons with chronic conditions. This is critical given the multiple crises facing the country and demographic changes (aging, high out-migration). To better integrate care the SDC Healthy Life project has built capacities and undertakes advocacy, including through participatory Policy Round table events, changes in legislative and normative acts, in line with EU succession, while also supporting practical application, interdisciplinary coordination and interventions across the health and social sectors. Methods: The project established a system for continuous support in implementation of integrated community care models for persons with noncommunicable diseases to be better cared for in their own communities. The process includes sectoral training of the Primary Health Teams (managers, family doctors, community nurses), training of the multidisciplinary community teams, support in development and implementation of the Plans for Integration of Community Care Services, practical support and supervision, collection of data and assessment of results. Multidisciplinary teams now apply integrated care that touch prevention, treatment, long-term care, home care, and primary palliative care. Learning from experiences in the social sector (e.g. with vulnerable children) common working tools and procedures are used to assess the needs of NCD patients and involve them along entire intervention process, as well as align eligibility criteria for health and social support, coordination within case management, data exchange, reciprocal referral, and joint follow-up and assessment of results. Results: After a range of introductory activities involving both MoH and MoLSP, all 35 districts of Moldova and 70 community teams have been involved in capacity building activities and supervision towards more integrated care. In the period of 2020-2023 sectorial training was delivered to 1.513 primary health care professionals and intersectoral to 709 members of community teams. The regular support in implementation is ensured for all teams. Additionally, these were supported to develop action plans that are implemented using a cascade principle to new pilot communities. Results from 2022 show that coordination of casework has improved, the roles and responsibilities of each actor are better known, the inefficiencies and duplications have been reduced. However, there are differences between the progresses made according to the level of interest, noting that there is a strong human factor to the issue of case management. Conclusions: Strengthening leadership and capacity of local implementers and promoting team approaches is fundamental. Successful districts have also applied the approach during the pandemic to maintain home visits to NCD patients that were high risk and could not visit health facilities. Further investments need to be made to better train professionals in integrated care principles, teamwork and communication, as well as meaningful collaboration with communities. Institutionalization of the developed training modules and interdisciplinary learning and work also remain pivotal, along with the approval of legal and normative frameworks to support integrated care.

Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result. Through the amendment, regenerative medicine is defined as a new category and is covered by the Relief Service under the amended Pharmaceutical Affairs Act, called the 'Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics' (PMD Act). This amendment allows the use of Relief Service data for pharmacovigilance activities, making the Relief Service the third adverse drug reaction reporting route in addition to the existing reporting routes from marketing authorization holders and healthcare providers. For optimum incorporation and use of this Relief Service data, earlier access should be allowed even before the reports from the Pharmaceuticals and Medical Devices Agency to the Ministry of Health, Labour and Welfare are finalized, which is mandatory under the current PMD Act.