"PMDA" の関連情報検索結果

Lupin and YL Biologics receives PMDA approval for Etanercept biosimilar in Japan - Lupin | Press ...



Lupin and YL Biologics receives PMDA approval for Etanercept biosimilar in Japan - Lupin | Press Release  lupin.com

Interview with MHLW and PMDA leadership - fda.gov



Interview with MHLW and PMDA leadership  fda.gov

Expediting Drug Development in Japan: A PMDA Perspective - Wiley



Expediting Drug Development in Japan: A PMDA Perspective  Wiley

Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first...



Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first  Regulatory Affairs Professionals Society | RAPS

PMDA makes case for Japan as a haven for innovation - BioWorld MedTech



PMDA makes case for Japan as a haven for innovation  BioWorld MedTech

Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement...



Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement System  PR Newswire

Japan’s PMDA completes inspection of Lupin’s Mandideep facility (Unit-2) - Lupin | Press Release ...



Japan’s PMDA completes inspection of Lupin’s Mandideep facility (Unit-2) - Lupin | Press Release  lupin.com

Eisai seeks PMDA approval for subcutaneous Leqembi in Japan - Pharmaceutical Technology



Eisai seeks PMDA approval for subcutaneous Leqembi in Japan  Pharmaceutical Technology

In Japan, regulatory success is built on consultation - The Pharma Letter



In Japan, regulatory success is built on consultation  The Pharma Letter

Koh Young accelerates Japan push after PMDA nod with neurosurgery showcases - CHOSUNBIZ - Chosunbiz



Koh Young accelerates Japan push after PMDA nod with neurosurgery showcases - CHOSUNBIZ  Chosunbiz

Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec - Yahoo Finance



Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec  Yahoo Finance

Symplicity Spyral renal denervation system gains Japanese PMDA approval - Vascular News



Symplicity Spyral renal denervation system gains Japanese PMDA approval  Vascular News

Nadofaragene firadenovec under regulatory review in Japan - Urology Times



Nadofaragene firadenovec under regulatory review in Japan  Urology Times

Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceu...



Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan  Frontiers

Asia-Pacific Roundup: PMDA outlines initiatives to promote pediatric drug development in Japan - ...



Asia-Pacific Roundup: PMDA outlines initiatives to promote pediatric drug development in Japan  Regulatory Affairs Professionals Society | RAPS

PMDA more open to use of clinical data from other nations - BioWorld MedTech



PMDA more open to use of clinical data from other nations  BioWorld MedTech

Japan’s PMDA issues GMP Certificate to Lupin’s Unit II Mandideep facility - Lupin | Press Release...



Japan’s PMDA issues GMP Certificate to Lupin’s Unit II Mandideep facility - Lupin | Press Release  lupin.com

MedHub-AI Receives PMDA Approval in Japan for AutocathFFR® - PR Newswire



MedHub-AI Receives PMDA Approval in Japan for AutocathFFR®  PR Newswire

Asia-Pacific Roundup: Japan’s PMDA starts offering consultation services from new US office - Reg...



Asia-Pacific Roundup: Japan’s PMDA starts offering consultation services from new US office  Regulatory Affairs Professionals Society | RAPS

Asia-Pacific Roundup: NMPA adopts policy to cut time between drug approval and market supply in C...



Asia-Pacific Roundup: NMPA adopts policy to cut time between drug approval and market supply in China  Regulatory Affairs Professionals Society | RAPS

Legacy Healthcare Receives Positive Feedback from Japan's Health Authority (PMDA) on Regulatory P...



Legacy Healthcare Receives Positive Feedback from Japan's Health Authority (PMDA) on Regulatory Pathway and Phase 3 Clinical Program for Cinainu in Japanese Children, Adolescents and Adults with Moderate to Severe Alopecia Areata (AA)  PR Newswire

BioCardia Advances CardiAMP Cell Therapy for Heart Failure with PMDA Consultation Completion - Qu...



BioCardia Advances CardiAMP Cell Therapy for Heart Failure with PMDA Consultation Completion  Quiver Quantitative

BioCardia (NASDAQ: BCDA) allowed to advance to formal PMDA consultation on CardiAMP HFrEF - stock...



BioCardia (NASDAQ: BCDA) allowed to advance to formal PMDA consultation on CardiAMP HFrEF  stocktitan.net

Asia-Pacific Roundup: India’s CDSCO halves clinical trial review timelines - Regulatory Affairs P...



Asia-Pacific Roundup: India’s CDSCO halves clinical trial review timelines  Regulatory Affairs Professionals Society | RAPS

ZBH Receives PMDA Approval in Japan for iTaperloc Complete and iG7 - Zacks Investment Research



ZBH Receives PMDA Approval in Japan for iTaperloc Complete and iG7  Zacks Investment Research

Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market - Regulatory Aff...



Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market  Regulatory Affairs Professionals Society | RAPS

Eisai and Biogen Submit New Drug Application for Subcutaneous LEQEMBI® to Japan's PMDA - Quiver Q...



Eisai and Biogen Submit New Drug Application for Subcutaneous LEQEMBI® to Japan's PMDA  Quiver Quantitative

Russia moves to withdraw from plutonium agreement with the United States - Reuters



Russia moves to withdraw from plutonium agreement with the United States  Reuters

Russia Moves to Formally Exit Landmark U.S. Plutonium Disposal Pact - The Moscow Times



Russia Moves to Formally Exit Landmark U.S. Plutonium Disposal Pact  The Moscow Times

178 Patient Trial Data: BioCardia's Breakthrough Cell Therapy for Heart Failure Advances in Japan...



178 Patient Trial Data: BioCardia's Breakthrough Cell Therapy for Heart Failure Advances in Japan  stocktitan.net

ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes - evotec.com



ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes  evotec.com

Koh Young wins Japan PMDA nod for brain surgery robot, eyes global push - CHOSUNBIZ - Chosunbiz



Koh Young wins Japan PMDA nod for brain surgery robot, eyes global push - CHOSUNBIZ  Chosunbiz

WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical...



WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical products  World Health Organization (WHO)

Russia moves to withdraw from plutonium agreement with the United States - thehindu.com



Russia moves to withdraw from plutonium agreement with the United States  thehindu.com

Korea, Japan ink medical device info sharing pact - BioWorld MedTech



Korea, Japan ink medical device info sharing pact  BioWorld MedTech

PMDA demolishes illegal structure at Panchkula’s oldest shrine Nau Gaza Peer | Hindustan Times - ...



PMDA demolishes illegal structure at Panchkula’s oldest shrine Nau Gaza Peer | Hindustan Times  Hindustan Times

PMDA rejects MC’s 100 acres land offer to set up Edu City - Times of India



PMDA rejects MC’s 100 acres land offer to set up Edu City  Times of India

Asia-Pacific Roundup: PMDA discusses changes to warning letters - Regulatory Affairs Professional...



Asia-Pacific Roundup: PMDA discusses changes to warning letters  Regulatory Affairs Professionals Society | RAPS

PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impac...



PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage  Wiley Online Library

Submitting clinical data to the FDA and PDMA: An efficient and compliant approach - BioSpectrum Asia



Submitting clinical data to the FDA and PDMA: An efficient and compliant approach  BioSpectrum Asia

Study notes disparities in new drugs approved in the US and Japan - Regulatory Affairs Profession...



Study notes disparities in new drugs approved in the US and Japan  Regulatory Affairs Professionals Society | RAPS

Following PMDA action in Panchkula: Sector-3 shrine voluntarily removes illegal structure | Hindu...



Following PMDA action in Panchkula: Sector-3 shrine voluntarily removes illegal structure | Hindustan Times  Hindustan Times

Easing Market Entry: Japan’s PMDA Allows Approval Filings In English - Citeline News & Insights



Easing Market Entry: Japan’s PMDA Allows Approval Filings In English  Citeline News & Insights

Two decades of new drug approvals in Japan - Nature



Two decades of new drug approvals in Japan  Nature

Asia-Pacific Roundup: Japan’s PMDA seeks to curb medical accidents - Regulatory Affairs Professio...



Asia-Pacific Roundup: Japan’s PMDA seeks to curb medical accidents  Regulatory Affairs Professionals Society | RAPS

Japan offers competitive edge with clinical trial landscape and SMO approach - Clinical Trials Arena



Japan offers competitive edge with clinical trial landscape and SMO approach  Clinical Trials Arena

Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand - Regulatory Affairs Pr...



Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand  Regulatory Affairs Professionals Society | RAPS

Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion - Regulator...



Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion  Regulatory Affairs Professionals Society | RAPS

WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again - BioSpectrum Asia



WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again  BioSpectrum Asia

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Isch...



BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval  Diagnostic and Interventional Cardiology

PMDA CEO conducts surprise inspection to fast-track Panchkula’s beautification drive - The Statesman



PMDA CEO conducts surprise inspection to fast-track Panchkula’s beautification drive  The Statesman

Japan PMDA opens second overseas office in Washington - BioWorld MedTech



Japan PMDA opens second overseas office in Washington  BioWorld MedTech

PMDA, HSIIDC begin pothole repair work in Panchkula - Times of India



PMDA, HSIIDC begin pothole repair work in Panchkula  Times of India

Aurion Biotech receives approval from Japan’s PMDA for New Drug Application - Ophthalmology Times



Aurion Biotech receives approval from Japan’s PMDA for New Drug Application  Ophthalmology Times

PMDA giving new momentum to urban development in Panchkula: CEO Pandurang - ET Infra



PMDA giving new momentum to urban development in Panchkula: CEO Pandurang  ET Infra

Op-ed: PMDA advances regulatory science-based “rational medicine” - foreignpolicy.com



Op-ed: PMDA advances regulatory science-based “rational medicine”  foreignpolicy.com

Russia Withdraws from Critical Weapons-Grade Plutonium Deal - Discovery Alert



Russia Withdraws from Critical Weapons-Grade Plutonium Deal  Discovery Alert

Biocon Biologics debuts its psoriasis biosimilar in Japan - ET Pharma



Biocon Biologics debuts its psoriasis biosimilar in Japan  ET Pharma

Belite Bio completes submission to PMDA to initiate Dragon II trial of Tinlarebant for the treatm...



Belite Bio completes submission to PMDA to initiate Dragon II trial of Tinlarebant for the treatment of adolescent Stargardt disease in Japan  Ophthalmology Times

PMDA’s proactive action to ensure quick drainage of rainwater in Panchkula city - The Impressive ...



PMDA’s proactive action to ensure quick drainage of rainwater in Panchkula city  The Impressive Times

Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystem...



Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystems  drugdiscoverytrends.com

JLK wins Japan’s approval for AI stroke diagnosis tool - koreabiomed.com



JLK wins Japan’s approval for AI stroke diagnosis tool  koreabiomed.com

Terumo Aortic announces PMDA approval for Thoraflex Hybrid in Japan - Vascular News



Terumo Aortic announces PMDA approval for Thoraflex Hybrid in Japan  Vascular News

Panchkula road damaged in 2 months: DC directs PMDA, HSVP to conduct inspection, submit report - ...



Panchkula road damaged in 2 months: DC directs PMDA, HSVP to conduct inspection, submit report  Times of India

Aerocrine Receives Clearance for FeNO Device in Japan - respiratory-therapy.com



Aerocrine Receives Clearance for FeNO Device in Japan  respiratory-therapy.com

Updates on Drug Regulations in Japan – Reducing Barriers to Entry for Drug Companies Entering the...



Updates on Drug Regulations in Japan – Reducing Barriers to Entry for Drug Companies Entering the Japanese Market  Winston & Strawn

Terumo Aortic announces PMDA approval for RelayPro endovascular device in Japan - Vascular News



Terumo Aortic announces PMDA approval for RelayPro endovascular device in Japan  Vascular News

PMDA'S PROACTIVE ACTION TO ENSURE QUICK DRAINAGE OF RAINWATER IN PANCHKULA CITY - Face2News



PMDA'S PROACTIVE ACTION TO ENSURE QUICK DRAINAGE OF RAINWATER IN PANCHKULA CITY  Face2News

Shape Memory Medical receives PMDA approval for the Impede-FX embolisation plug - Vascular News



Shape Memory Medical receives PMDA approval for the Impede-FX embolisation plug  Vascular News

PMDA announces ‘New Year gift’ for Panchkula with two mega infrastructure projects - Punjab Newsline



PMDA announces ‘New Year gift’ for Panchkula with two mega infrastructure projects  Punjab Newsline

Convergence: Understanding expedited approval pathways in Japan - Regulatory Affairs Professional...



Convergence: Understanding expedited approval pathways in Japan  Regulatory Affairs Professionals Society | RAPS

Japan keen to deepen regional partnerships, says PMDA head - BioWorld MedTech



Japan keen to deepen regional partnerships, says PMDA head  BioWorld MedTech

PMDA Japan and Medical Device Regulation - TÜV SÜD



PMDA Japan and Medical Device Regulation  TÜV SÜD

Boston Scientific receives Japanese regulatory approval for Farapulse PFA system - Cardiac Rhythm...



Boston Scientific receives Japanese regulatory approval for Farapulse PFA system  Cardiac Rhythm News

Decks cleared for recarpeting of bad roads in Panchkula - Times of India



Decks cleared for recarpeting of bad roads in Panchkula  Times of India

Japan’s PMDA grants clearance for Priothera to commence AML therapy - Clinical Trials Arena



Japan’s PMDA grants clearance for Priothera to commence AML therapy  Clinical Trials Arena

Alpha Tau Submits to Japanese PMDA for Pre-Market Approval of Alpha DaRT in Patients with Recurre...



Alpha Tau Submits to Japanese PMDA for Pre-Market Approval of Alpha DaRT in Patients with Recurrent Head and Neck Cancer  Yahoo Finance

Panchkula gets monsoon-ready, officials directed to complete flood control measures by June 15 - ...



Panchkula gets monsoon-ready, officials directed to complete flood control measures by June 15  Times of India

Lecanemab Receives Priority Review Status in Japan - Biogen



Lecanemab Receives Priority Review Status in Japan  Biogen

The Complete Guide to Using AI in the Healthcare Industry in Japan in 2025 - nucamp.co



The Complete Guide to Using AI in the Healthcare Industry in Japan in 2025  nucamp.co

Eyes on every street: Panchkula to launch AI-powered city control centre | Hindustan Times - Hind...



Eyes on every street: Panchkula to launch AI-powered city control centre | Hindustan Times  Hindustan Times

Two darbepoetin alfa biosimilars submitted to Japan’s PMDA - Generics and Biosimilars Initiative



Two darbepoetin alfa biosimilars submitted to Japan’s PMDA  Generics and Biosimilars Initiative

PMDA's proactive action to ensure quick drainage of rainwater in Panchkula city - Punjab Newsline



PMDA's proactive action to ensure quick drainage of rainwater in Panchkula city  Punjab Newsline

JAPAC Drug Development: Navigating Safety & Regulatory Requirements - HIT Consultant



JAPAC Drug Development: Navigating Safety & Regulatory Requirements  HIT Consultant

PMDA CEO inspects Panchkula city, directs removal of encroachments along roads within 3 days - Pu...



PMDA CEO inspects Panchkula city, directs removal of encroachments along roads within 3 days  Punjab Newsline

Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process - BioPharm I...



Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process  BioPharm International

Haryana Shehar Swachhata Abhiyan: PMDA CEO Inspects Panchkula, Orders Encroachment Removal in 3 D...



Haryana Shehar Swachhata Abhiyan: PMDA CEO Inspects Panchkula, Orders Encroachment Removal in 3 Days  The Hans India

Visualising PCP Metrics Using Grafana - Oracle Blogs



Visualising PCP Metrics Using Grafana  Oracle Blogs

Japanese guidelines for biosimilars - Generics and Biosimilars Initiative



Japanese guidelines for biosimilars  Generics and Biosimilars Initiative

LG Chem and CJ CheilJedang Join Forces to Commercialize Bio-Nylon - Lgcorp.com



LG Chem and CJ CheilJedang Join Forces to Commercialize Bio-Nylon  Lgcorp.com

Current situation and issues regarding termination of risk management plans in Japan - Frontiers



Current situation and issues regarding termination of risk management plans in Japan  Frontiers

PMDA Japan and Medical Device Regulation - TÜV SÜD



PMDA Japan and Medical Device Regulation  TÜV SÜD

Sexton Biotechnologies and Ikeda Scientific Provide Human Platelet Lysate to Japanese Regenerativ...



Sexton Biotechnologies and Ikeda Scientific Provide Human Platelet Lysate to Japanese Regenerative Medicine Product Manufacturers  BioSpace

Explainer: What is the govt's proposed media authority and why has it invited criticism? - Dawn



Explainer: What is the govt's proposed media authority and why has it invited criticism?  Dawn

China And Japan Encourage Clinical Research By Streamlining Approval - Clinical Leader



China And Japan Encourage Clinical Research By Streamlining Approval  Clinical Leader

Companion Diagnostics Regulations are Evolving in Asia - MedTech Intelligence



Companion Diagnostics Regulations are Evolving in Asia  MedTech Intelligence

Pakistan: Government must heed media protests against controversial PMDA bill - International Fed...



Pakistan: Government must heed media protests against controversial PMDA bill  International Federation of Journalists - IFJ

Panchkula to get 'smart road' from Majri Chowk to railway station - ET Infra



Panchkula to get 'smart road' from Majri Chowk to railway station  ET Infra

The New ICH M12 Guideline – Harmony at Last for DDI Studies! - evotec.com



The New ICH M12 Guideline – Harmony at Last for DDI Studies!  evotec.com

National Cancer Center Japan and Pharmaceuticals and Medical Devices Agency Endorsed as a joint C...



National Cancer Center Japan and Pharmaceuticals and Medical Devices Agency Endorsed as a joint Center of Excellence by APEC  ncc.go.jp