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1 Welcome to Ministry of Health, Labour and Welfare
https://www.mhlw.go.jp/english/
Policy Information · Employment Security ,Labour. Employment Security · Human Resources Development · Labour Standards · Equal Employment · Part-Time, Dispatched ...
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2 Revision of Japanese Medical Device QMS requirements
https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html
The Japanese medical device Quality Management System requirements are stipulated in MHLW Ministerial Ordinance No. 169 (2004) titled "the Ministerial ...
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3 Japan's MHLW publishes biocompatibility testing guidance
https://www.emergobyul.com/news/japanese-regulatory-ministry-publishes-guidance-biocompatibility-testing-updated-standard
Japanese Regulatory Ministry Publishes Guidance on Biocompatibility Testing to Updated Standard ... The Ministry of health, labour and welfare (MHLW) has ...
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4 MHLW's Guidelines for Promoting and Establishing High ...
https://www.jil.go.jp/english/jli/documents/2021/034-01.pdf
Japan Labor Issues, vol.5, no.34, October-November 2021. Trends. On March 25, the Ministry of Health, Labour and Welfare (MHLW) published a guideline titled.
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5 Japan MHLW Ordinance 21 Good Laboratory Practice for ...
https://validationcenter.com/library/library/regulations-and-guidelines/japan-mhlw-ordinance-21-good-laboratory-practice-nonclinical-safety-studies-drugs-608-2/
Japan's Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs was published to provide the GLP standards for conducting ...
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6 Japan Medical Device & Pharmaceutical Regulations - PMDA ...
https://www.pacificbridgemedical.com/regulation/japan-medical-device-pharmaceutical-regulations/
Current Japan PMDA regulations are laid out in the Pharmaceuticals and Medical Devices Act (PMD Act), also known as the Act on Securing ...
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7 Regulatory Updates on Medical Devices in Japan
https://www.imdrf.org/sites/default/files/2022-09/Japan_0.pdf
MHLW approval. (PMDA review). Example. Post market safety. ( vigilance/surveillance). PMDA and MHLW. Medical Device Regulations in Japan.
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8 Pharmaceutical Administration and Regulations in Japan
https://www.nihs.go.jp/mhlw/yakuji/yakuji-e_20110502-02.pdf
Pharmaceutical Regulations in Japan: 2011-3. - 2 - reliability of application data. Following this reorganization, the MHLW and.
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9 Japan's MHLW updates medical device program display code ...
https://www.ris.world/japan-japans-mhlw-updates-medical-device-program-display-code-and-labeling-laws/
Japan's medical device regulators have updated regulations and implementation guidelines for enforcement of the PMD Act and bar code ...
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10 Sample size considerations for Japanese patients in a multi ...
https://pubmed.ncbi.nlm.nih.gov/19499510/
Since the publication of the International Conference on Harmonization E5 guideline, new drug approvals in Japan based on the bridging strategy have been ...
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11 MHLW JAPAN, 厚生労働省 - New Drug Approvals
https://newdrugapprovals.org/mhlw-japan/
It is commonly known as Kōrō-shō (厚労省) in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food ...
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12 organization and function of the ministry of health, labour and ...
https://www.jpma.or.jp/english/about/parj/eki4g6000000784o-att/2020e_ch01.pdf
Pharmaceutical Regulations in Japan: ... The MHLW is in charge of pharmaceutical ... and Pharmaceuticals and Medical Devices Agency. (PMDA)).
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13 Considerations In Heading East: A Beginner's Guide To Japan ...
https://www.odtmag.com/issues/2022-09-01/view_columns/considerations-in-heading-east-a-beginners-guide-to-japan-and-pmda/
Over the last decade, Japanese regulatory authorities (PMDA and MHLW) have taken steps to harmonize efforts with the U.S. Food and Drug ...
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14 A quick regulatory guide to telehealth services in Japan
https://www.healthcareitnews.com/news/asia/quick-regulatory-guide-telehealth-services-japan
The MHLW Telemedicine Guidelines require physicians engaging in telemedicine to comply with obligations provided therein, and also require a ...
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15 Japan Medical Device Regulations - RegDesk
https://www.regdesk.co/resource-library/japan/
Japan Medical Device Regulations ; Notification by PMDA, Certification by Registered Certified Body (RCB), Approval by MHLW ; Application for product notification ...
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16 Japanese ERES Guideline
https://ecompliance.co.jp/english/Japanese%20ERES%20Guideline.html
149 of 2004, here after e-Document Law). And also regarding materials submitting to MHLW, there are instructions by “the notification of data items and ...
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17 COVID-19 Negative Test Result Certificate before departure ...
https://www.mofa.go.jp/ca/fna/page25e_000334.html
COVID-19 Negative Test Result Certificate before departure / Valid COVID-19 Vaccination Certificate ... Please refer to the following MHLW's websites for more ...
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18 Japan Pharmaceutical Affairs Law - BSI
https://www.bsigroup.com/meddev/LocalFiles/zh-cn/Services/BSI-md-pharmaceutical-affairs-law-jpal-product-guide-zh-cn.pdf
MHLW Ministerial ordinance No. 2, Regulations for Building and. Facilities, must be met by the medical devices manufacturers in order to obtain accreditation by ...
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19 MHLW Notification No. 210 - Jouhou Koukai
http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=PROD&Product_Code=7_D_K004&Category_Code=MDNG
MHLW Notification No. 210 - Standards for Raw Materials Originating from Living Organisms · 7_D_K001, Agreement on Mutual Recognition between Japan and EC: ...
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20 Japan | REGION-Map
https://www.hsph.harvard.edu/region-map/research_project/japan/
Fundamental Principles of Research on the Human Genome (2000); MHLW: Guidelines for Clinical Research Using Human Stem Cells (2013). MEXT: Guidelines on the ...
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21 JISHA: Japan Industrial Safety and Health Association ...
https://www.jisha.or.jp/english/
Japan Industrial Safety and Health Association(English Page) ... of Prevention of Heatstroke, MHLW · Statistics of Workers' Health Condition in Japan (2021) ...
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22 Japan: MHLW and MAFF Update Policies and Procedures for ...
https://www.fas.usda.gov/data/japan-mhlw-and-maff-update-policies-and-procedures-genome-edited-food-and-agricultural
This report reflects updates made by the Government of Japan to its guidelines for handling food and agricultural products derived from ...
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23 MHLW's new guideline for Good Distribution Practice (Japan)
https://uk.practicallaw.thomsonreuters.com/w-018-8539?transitionType=Default&contextData=(sc.Default)
On 28 December 2018, the Ministry of Health, Labour and Welfare (MHLW) published a new guideline (Japanese language) for Good Distribution ...
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24 Japan's MHLW Strengthens Cosmetics Supervision
https://www.ul.com/news/japans-mhlw-strengthens-cosmetics-supervision
The Ministry of Health, Labour and Welfare (MHLW) announced in the MHLW Ordinance NO.13 an amendment to the Implementation Rule of Pharmaceutical Affairs ...
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25 PMDA Japan and Medical Device Regulation - TUV Sud
https://www.tuvsud.com/en-in/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-devices-and-compliance-with-japan-pal-regulations
Medical Devices and Compliance with Japan's PAL Regulations ... Medical Devices Agency (PMDA) is Japan's regulatory agency that works together with MHLW.
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26 Bringing Medications into Japan
https://www.us.emb-japan.go.jp/itpr_en/bringing-medications-to-japan.html
However, the Embassy of Japan must adhere to Japan's regulations and does not have the authority to ... EMAIL: [email protected].
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27 Pharmaceuticals in the Environment | Eureka blog
https://www.criver.com/eureka/pharmaceuticals-environment
This MHLW Guidance is regarded an official document for assessment of adverse effects against the environment in Japan that are caused by ...
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28 Food product and safety regulation | Japan
https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/japan/topics/food-product-and-safety-regulation
Japan does not have specific laws or regulations regarding the use or ... unless the Minister of Health, Labor and Welfare ("MHLW") has declared them as ...
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29 ES10.02 Japan Pharmaceuticals and Medical Devices Agency
https://www.jto.org/article/S1556-0864(19)30795-6/fulltext
Other than orphan drugs, the MHLW designates medical products as priority review products based on the following criteria described: 1.
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30 MHLW Inspection Services - Pressure vessels and boilers
https://www.lrqa.com/en/mhlw-inspection-services/
The Ministry of Health, Labour and Welfare (MHLW) in Japan sets requirements for the construction of certain types of boilers and pressure vessels.
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31 Ministry of Health, Labour and Welfare - Wikipedia
https://en.wikipedia.org/wiki/Ministry_of_Health,_Labour_and_Welfare
The Ministry of Health, Labour and Welfare is a cabinet level ministry of the Japanese ... of Health, Labor and Welfare. Website, http://www.mhlw.go.jp ...
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32 The Japanese Perspective - Wiley Online Library
https://onlinelibrary.wiley.com/doi/pdf/10.1002/9781118312087.ch16
of drugs in Japanese children is common as in ... Japan does not have “pediatric regulations” ... Welfare (MHLW)/Pharmaceutical and Medical.
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33 Information for U.S. citizens traveling to Japan
https://jp.usembassy.gov/services/welcomebacktojapan/
Please visit Ministry of Foreign Affairs webpage for updated guidance on COVID19 travel requirements for entering Japan. Starting November 1, 2022, travelers to ...
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34 Latest Initiatives in Telemedicine and Online Medical ...
https://japanhpn.org/en/ict-4-2/
MHLW will not formulate regulations restricting the practice of online consultation to doctors who have undergone training so as to incentivize its adoption.
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35 Devine Guidance for Complying with Japan's Quality System ...
https://www.amazon.com/Devine-Guidance-Complying-Quality-Regulation/dp/1490927778
Devine Guidance for Complying with Japan's Quality System Regulation: MHLW Ministerial Ordinance 169 [Devine, Dr. Christopher Jospeh] on Amazon.com.
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36 Tokyo N4G Summit MHLW Official Side Event III - - YouTube
https://www.youtube.com/watch?v=cWU9TUmajOA
Mar 28, 2022
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37 Japan | European Medicines Agency
https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/japan
EMA, the MHLW and PMDA have agreed to establish a fellowship programme in 2017, which involves exchanging staff for a short period of time. These exchanges ...
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38 Policies to Promote Development of AI-Based Medical ...
https://globalforum.diaglobal.org/issue/november-2021/policies-to-promote-development-of-ai-based-medical-devices-in-japan/
Japan Association for the Advancement of Medical Equipment (JAAME) ... March 2019: Draft Review Guidance for AI Medical Devices (MHLW, NIHS).
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39 Japan Partially Amends Specification and Standards for Food ...
https://selerant.com/resources/food-regulatory-news/japan-partially-amends-specification-and-standards-for-food-and-food-additives
On August 10, 2022, the Ministry of Health, Labour and Welfare - MHLW of Japan published “Partial Amendment of Specifications and Standards ...
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40 Japanese Ministry of Health, Labour and Welfare (MHLW)
https://www.rerf.or.jp/en/glossary/jmhw-en/
Japanese Ministry of Health, Labour and Welfare (MHLW). Funds for the operation of RERF are provided by the government of Japan through the Ministry of ...
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41 New Regulatory Framework for Medical Devices in Japan
https://www.jvir.org/article/S1051-0443(17)31159-4/pdf
Therefore, MHLW has revised the scope of clinical trial requirements in the new regulatory guidance (27). The new guidance is expected to reduce the development.
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42 Japan Health System Review
https://apps.who.int/iris/bitstream/handle/10665/259941/9789290226260-eng.pdf
template provides detailed guidelines and specific questions, definitions ... in Japan, the MHLW set cut off point for obesity as BMI ≥25 kg/m2.
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43 Press Release | MIC ICT Policy - 総務省
https://www.soumu.go.jp/main_sosiki/joho_tsusin/eng/pressrelease/2021/4/23_05.html
Accordingly, MIC, MHLW, and METI have decided to open them to the public. ... April 23, 2021 Release of Basic Guidelines for the Management of Health and ...
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44 MHLW Definition: 415 Samples | Law Insider
https://www.lawinsider.com/dictionary/mhlw
Define MHLW. means the Japanese Ministry of Health, Labour and Welfare, ... with US FDA GLP regulations, Japan MHLW GLP regula- tions or OECD GLP guidance.
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45 Medical Device Regulation i Jn apan
http://ahwp.info/sites/default/files/Medical_Device_Regulation_in_Japan.pdf
heart valves. (MHLW Ministerial Notification No.298, July 20, 2004 ) ... =JIS(Japanese Industrial Standards) plus Indication. + harmonized with ISO/IEC.
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46 Draft Guidelines for Secure Working Conditions for ...
https://www.meti.go.jp/english/press/2021/0326_003.html
... the Japan Fair Trade Commission (JFTC), SMEA and the Ministry of Health, Labour and Welfare (MHLW), it formulated and hereby releases a ...
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47 Registering Nutraceuticals In Japan | Credevo Articles
https://credevo.com/articles/2022/09/05/top-4-considerations-for-registering-nutraceuticals-food-products-in-japan/
The MHLW may also develop guidelines for the production, processing, use, preparation, or preservation of food or additives, and standards for ...
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48 Pharmaceutical Advertising Laws and Regulations Japan 2022
https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/japan
The PMD Act, supplemented by administrative notices and guidelines issued by the Ministry of Health Labour and Welfare (“MHLW”), sets basic standards for drug ...
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49 An Overview of Pharmaceutical and Medical Device ...
https://www.morganlewis.com/-/media/files/publication/outside-publication/article/overview_pharma_device_reg.ashx
cal device, the PMDA will make an approval recom- ... in or sold into Japan must be approved by the MHLW. In ... satisfy criteria established by the MHLW.
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50 Value in Health
https://www.valueinhealthjournal.com/article/S1098-3015(16)31306-7/pdf
submitted to the Ministry of Health, Labour and Welfare (MHLW), ... ously proposed guidelines for academic researchers in Japan.
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51 ICH Harmonisation and Japanese Pharmaceutical Regulations
https://admin.ich.org/sites/default/files/inline-files/Regulatory_perspective_-_Yukio_Hiyama.pdf
- Risk management. - Technology transfer. - Change control, etc. From MHLW slides at 2003 Work Shop. Page 6. 6. ICH ...
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52 MDCPSS SPRING NEWSLETTER
https://www.toxicology.org/groups/ss/MDCPSS/docs/MDCPSS-2022-SPRING-NEWSLETTER-FINAL.pdf
Japanese biological safety evaluation is harmonized with the ISO standards, as MHLW No. 0106-1 states in. Section 3 of “Basic Principles for ...
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53 International Code Japan MHLW - Munich Re
https://www.munichre.com/content/dam/munichre/contentlounge/website-pieces/documents/hsb-gies-156-international-codes-mhlw-20191010.pdf/_jcr_content/renditions/original.media_file.download_attachment.file/hsb-gies-156-international-codes-mhlw-20191010.pdf
Exporting boilers and pressure vessels requires a complete understanding of destination rules and requirements. HSB has an experienced staff ...
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54 PSEHB/SD Notification No.0608-1
http://www.phrma-jp.org/wordpress/wp-content/uploads/2019/05/PSEHBSD-Notification-No.0608-1_E_1.1.pdf
Translated by PhRMA Japan (Pharmaceutical Research and Manufacturers of America Japan) ... with consultation to MHLW (Ministry of Health, ...
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55 New Japanese Initiatives on Stem Cell Therapies
https://www.cell.com/cell-stem-cell/pdf/S1934-5909(15)00123-X.pdf
based regulations in Japan providing ... ucts Act'' (http://www.hourei.mhlw.go.jp/ ... cell clinical research guidelines,'' which.
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56 Market Access of Medical Devices in Japan - Johner Institute
https://www.johner-institute.com/articles/regulatory-affairs/and-more/authorization-of-medical-devices-in-japan/
The mission of the MHLW is to protect the population of Japan against health hazards caused by pharmaceutical products and medical devices that ...
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57 Maximization Sensitization Study – Japanese MHLW - NAMSA
https://namsa.com/tests/maximization-sensitization-study-japanese-mhlw-method-1/
Standards. ISO 10993-10. Sensitization tests are utilized to evaluate the potential of medical devices, bio-materials, or their extracts tissues to cause a ...
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58 Understanding Japan's Medical Device Certification System
https://www.mddionline.com/news/understanding-japans-medical-device-certification-system
It aligns Japan's regulatory requirements more closely with those of other ... Labour, and Welfare (MHLW), Japan's equivalent of FDA.
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59 Japan - Data Protection Overview | Guidance Note
https://www.dataguidance.com/notes/japan-data-protection-overview
The APPI applies to every PIC in Japan, whether a person or entity; though the General Guidelines relax the standards of security measures for 'small or medium ...
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60 MHLW probe into Diovan likely to see tighter clinical trial ...
https://www.spglobal.com/marketintelligence/en/mi/country-industry-forecasting.html?ID=1065982070
Japan's Ministry of Health, Labour and Welfare (MHLW) has opened ... Separately, the Japanese Society of Hypertension's draft guidelines on ...
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61 Japan updates guidelines for cybersecurity, single-use ...
https://www.bioworld.com/articles/516406-japan-updates-guidelines-for-cybersecurity-single-use-devices-and-mdsap
Japan's Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory ...
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62 Japan Post Market Surveillance - Asia Actual
https://asiaactual.com/japan/post-market-surveillance/
Adverse Events Reporting Timeline ... The MAH must report serious Adverse Drug Reactions (ADR) to the MHLW within 15 days (new drugs on the market for less than 2 ...
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63 Japanese bioanalytical method validation guideline
https://www.future-science.com/doi/pdf/10.4155/bio.15.43
Labour and Welfare (MHLW) of Japan [1]. This Guideline, hereinafter referred to as the. 'MHLW LBA Guideline,' is the world's first.
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64 Policies, initiatives and tools to promote women's economic ...
https://www.ilo.org/wcmsp5/groups/public/---ed_emp/---emp_ent/---multi/documents/briefingnote/wcms_724865.pdf
MHLW Guideline on supporting measures taken by workers and employers aiming at eliminating gender pay gap (August 2010). (Ministry Website in Japanese).
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65 Japanese Regulatory Perspective on Vaccine Development
https://ccs.ncgm.go.jp/050/en/iidf/Japanese_Regulatory_Perspective_on_Vaccine_Development.pdf
PMDA/MHLW published guidelines to promote development vaccine originated from Japan. Page 52. Pharmaceuticals and Medical Devices Agency (PMDA). Thank you for ...
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66 Development of an Official Guideline for the Economic ...
https://www.sciencedirect.com/science/article/pii/S1098301516313067
Table 1. Present state of economic evaluation submitted to the MHLW [1] ... Table 2. Summary of Japanese guideline for cost-effectiveness evaluation ...
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67 Optimal Use Guidelines and Reimbursement Restrictions in ...
https://goddardhealth.com/f/optimal-use-guidelines-and-reimbursement-restrictions-in-japan
Like many rules in Japan, however, there are a few notable exceptions. ... However, at the time of its reimbursement the MHLW's Central ...
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68 Japan Software as a medical device (SaMD)
https://www.trade.gov/market-intelligence/japan-software-medical-device-samd
Recognizing this gap, the Ministry of Health, Labour and Welfare (MHLW) has taken several recent steps to promote early product commercialization of SaMD.
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69 Pharmaceutical Administration and ... - ResearchGate
https://www.researchgate.net/profile/Entedhar-Sarhat/post/How_to_get_the_information_about_the_list_of_drugs_under_the_clinical_trial_for_a_given_disease/attachment/5af9da2ab53d2f63c3cbc615/AS%3A626261370101765%401526323754506/download/Regulatory+Information+Task+Force.pdf
The MHLW is in charge of pharmaceutical regulatory affairs in Japan (veterinary drugs are under the jurisdiction of the Ministry of Agriculture, Forestry.
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70 Japan - Commonwealth Fund
https://www.commonwealthfund.org/international-health-policy-center/countries/japan
Japan's prefectures implement national regulations, ... 30 MHLW, What the Ministry of Health, Labour and Welfare Does for the Elderly (in ...
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71 Chapter 1. The Public Health System in Japan - OECD iLibrary
https://www.oecd-ilibrary.org/sites/9789264311602-5-en/index.html?itemId=/content/component/9789264311602-5-en
The MHLW establishes the standards for food contents, and monitors whether the rules are complied with for domestic food, and implements quarantine tests for ...
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72 MHLW - The Japan Times
https://www.japantimes.co.jp/tag/mhlw/
Comprehensive news coverage of Japan's Ministry of Health, Labour and Welfare. ... Nintendo praised for new rules against customers who harass staff ...
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73 Establishing health priorities in Japan
https://www.openaccessgovernment.org/establishing-health-priorities-in-japan/121906/
To achieve this vision, the MHLW follows four principal guidelines which are outlined below: Carrying out all tasks in a fair manner, by high ...
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74 Japan strengthens protection against workplace harassment
https://www.mercer.com/our-thinking/law-and-policy-group/japan-strengthens-protection-against-workplace-harassment.html
Japanese employers must take action to combat workplace harassment ... The MHLW has published guidelines that provide more detail about employers' duties.
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75 Pharmaceutical Administration and Regulations ... - Elsi Project
https://www.elsi-project.eu/fileadmin/user_upload/elsi/brosch%C3%BCren/Pharmaceutical_Regulations_in_Japan_JPMA__DOCUMENT_.pdf
Pharmaceutical Regulations in Japan: 2012-3. - 2 - reliability of application data. Following this reorganization, the MHLW and.
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76 Nursing and patient safety in Japan - 日本看護協会
https://www.nurse.or.jp/jna/english/pdf/safety-01.pdf
... Safety” is used in Japan in the text of the Medical Care Act as well as in various guidelines of the Ministry of Health, Labour and Welfare (MHLW).
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77 US/Japan Regulatory Collaboration - FDA
https://www.fda.gov/medical-devices/cdrh-international-programs/usjapan-regulatory-collaboration
Through the U.S. - Japan Medical Device Harmonization by Doing ... promote regulatory convergence between FDA and MHLW premarket reviews and ...
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78 Japanese Guidance on the Manufacture of Sterile ...
https://www.gmp-compliance.org/guidelines/gmp-guideline/japanese-guidance-on-the-manufacture-of-sterile-pharmaceutical-products-by-aseptic-processong
Japanese requirements on aseptic processing. ... Pharmaceutical and Medical Device Agency, Japan. Content: Japanese requirements on aseptic processing.
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79 COVID-19 Information and Resouces
https://corona.go.jp/en/
On April 7, 2020, the Government of Japan declared a state of emergency in relation to the novel coronavirus disease (COVID-19).
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80 Medicinal product regulation and product liability in Japan
https://content.next.westlaw.com/practical-law/document/Id4af42f61cb511e38578f7ccc38dcbee/Medicinal-product-regulation-and-product-liability-in-Japan-overview?viewType=FullText&transitionType=Default&contextData=(sc.Default)
The Pharmaceuticals Law sets out certain regulations concerning the packaging and labelling of medicinal products. The MHLW is the primary authority to enforce ...
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81 Japan's MHLW Approves Pfizer's CIBINQO® (abrocitinib) for ...
https://www.pfizer.com/news/press-release/press-release-detail/japans-mhlw-approves-pfizers-cibinqor-abrocitinib-adults
Japan's MHLW Approves Pfizer's CIBINQO® (abrocitinib) for Adults and Adolescents with Moderate to Severe Atopic Dermatitis. Thursday, September ...
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82 Guide to Compliance with the Japanese Positive List
https://nationalaglawcenter.org/publication/download/jones-guide-to-compliance-with-the-japanese-positive-list-national-aglaw-center-publications-9-2008/
Effective May 29, 2006, the MHLW implemented new regulations on the permissible. MRLs of agricultural chemicals in food. In establishing these new ...
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83 Life Science Government Initiatives - Investing in Japan
https://www.jetro.go.jp/en/invest/attractive_sectors/life_science/government_initiatives.html
In addition, in March 2019, the MHLW compiled guidelines to promote the development and efficiency of immunotherapy. Known as the “fourth pillar of cancer ...
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84 Barcode Marking on Medical Devices in Japan
https://www.gs1jp.org/assets/img/pdf/Japan_Bar_Code_Guideline_Harayama.pdf
IT Infrastructure for Medical Device Industry in Japan. 3. Factors for success in standardization. 4. Guidelines of MHLW harmonized with GS1.
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85 The Impact of Recent Revisions in the Japanese Ethical ...
https://muse.jhu.edu/pub/43/article/416360/summary
These include “Ethical Guidelines for Clinical Research (EGCR)”1 issued by the Ministry of Health, Labor, and Welfare (MHLW), “Ethics Guidelines for ...
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86 Guidelines for Preventing the Spread of Novel Coronavirus ...
https://www.keidanren.or.jp/en/policy/2020/040_guideline1.html
They are based on the Basic Policies for Novel Coronavirus Disease Control by the Government of Japan (announced on March 28, revised on May ...
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87 Life Sciences 2022 - Japan - Chambers Global Practice Guides
https://practiceguides.chambers.com/practice-guides/life-sciences-2022/japan/trends-and-developments
Since then, the MHLW has updated the guidelines regarding online medical treatment, the latest of which is the "Guideline on Adequate Conduct of ...
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88 Japan's Regulation of Food Contact Materials - A Step Closer ...
https://www.khlaw.com/insights/japans-regulation-food-contact-materials-step-closer-new-positive-list-system?language_content_entity=en
[3] MHLW is now in the process of compiling a positive list of substances permitted for use in plastic food-contact materials, starting first ...
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89 Precision Oncology and the Universal Health Coverage ...
https://ascopubs.org/doi/full/10.1200/PO.19.00291
The Japanese MHLW has a structured system to promote the development of ... The requirements of designated core hospitals for cancer genome ...
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90 The Current Status and Future Direction of Clinical Research ...
https://www.frontiersin.org/articles/10.3389/fmed.2021.816921/full
Clinical research in Japan must be conducted appropriately while ... This guideline is known as the Ethical Guidelines for Medical and ...
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91 OECD Reviews of Public Health: Japan
https://www.oecd.org/health/health-systems/OECD-Reviews-of-Public-Health-Japan-Assessment-and-recommendations.pdf
Public Health Risk Management in MHLW . ... Cancer screening guidelines in Japan do not completely align with international recommendations .
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92 Healthcare Enforcement & Litigation 2022
https://www.mhmjapan.com/content/files/00050294/2022_healthcare_enforcement_and_litigation_japan.pdf
In Japan, under the universal healthcare insurance system designed ... The MHLW is responsible for the regulation of pharmaceutical prod-.
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93 YAKUSHOKUKIHATSU No - TS Quality & Engineering
https://tsquality.ch/wp-content/uploads/2020/02/Japan-guidance-for-device-applications1-of-2.pdf
Welfare (MHLW), dated February 16, 2005, “Application for Marketing Approval ... Laboratories (Q17025) established by the Japan Industrial Standards (JIS).
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94 Japan at a Crossroads: Reconciling Drug Price Reform and ...
https://www.gtlaw.com/en/insights/2022/1/japan-at-a-crossroads-reconciling-drug-price-reform-and-innovation
The Ministry of Health, Labor, and Welfare of Japan (MHLW) announced its new ... optimal use promotion guidelines, and cost-effectiveness ...
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95 2019 PMDA Guideline (English Translation ... - XenoTech
https://www.xenotech.com/access-adme-research-resources/resources/2019-japanese-pmda-guideline-english-translation/
In 2019, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan released the official English translation of their guidance for industry.
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96 Exporting Boilers - International Code; Japan MHLW from HSB
https://www.globalspec.com/FeaturedProducts/Detail/HartfordSteamBoiler/Exporting_Boilers_International_Code_Japan_MHLW/313430/0
MHLW Requirements: All boilers and pressure vessels destined for Japan must be examined and certified by a local Japanese Labor Bureau or Japan's Individual ...
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