"PMDA" の関連情報検索結果

Expediting Drug Development in Japan: A PMDA Perspective - Kohno - 2025 - Wiley



Expediting Drug Development in Japan: A PMDA Perspective - Kohno - 2025  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

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

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in...



PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; encorafenib for colorectal cancer, daratumumab for multiple myeloma, repotrectinib for NTRK-fusion positive solid tumors, and venetoclax for leukemia  springermedicine.com

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

New gene therapy and weekly birth control patch move forward at Viatris - Stock Titan



New gene therapy and weekly birth control patch move forward at Viatris  Stock Titan

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

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



Symplicity Spyral renal denervation system gains Japanese PMDA approval  Vascular News

VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001 - GlobeNewswire



VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001  GlobeNewswire

BioCardia completed third preliminary clinical consultation with Japan’s PMDA - TipRanks



BioCardia completed third preliminary clinical consultation with Japan’s PMDA  TipRanks

Eisai seeks PMDA approval for subcutaneous Leqembi in Japan - Yahoo



Eisai seeks PMDA approval for subcutaneous Leqembi in Japan  Yahoo

Nadofaragene firadenovec under regulatory review in Japan - Urology Times



Nadofaragene firadenovec under regulatory review in Japan  Urology Times

Asia-Pacific Roundup: PMDA posts points to consider for psoriatic arthritis clinical trials - Reg...



Asia-Pacific Roundup: PMDA posts points to consider for psoriatic arthritis clinical trials  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

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  Stock Titan

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: 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

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: 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

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

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

JLK secures Japan PMDA approval for brain MRI AI solution - koreabiomed.com



JLK secures Japan PMDA approval for brain MRI AI solution  koreabiomed.com

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

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

Biocardia cell therapy to enter PMDA clinical consultation - marketscreener.com



Biocardia cell therapy to enter PMDA clinical consultation  marketscreener.com

Asia-Pacific Roundup: Japan’s PMDA shares thinking on showing clinical efficacy in chronic skin c...



Asia-Pacific Roundup: Japan’s PMDA shares thinking on showing clinical efficacy in chronic skin condition  Regulatory Affairs Professionals Society | RAPS

Pyromellitic Dianhydride (PMDA) Market 2025 Highlights Latest - openPR.com



Pyromellitic Dianhydride (PMDA) Market 2025 Highlights Latest  openPR.com

BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA ...



BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA Approval for CardiAMP® Cell Therapy for Heart Failure and Helix™ Transendocardial Delivery Catheter  GlobeNewswire

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



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

Russia Approves Move To Withdraw From Landmark Plutonium Deal With US - NDTV



Russia Approves Move To Withdraw From Landmark Plutonium Deal With US  NDTV

BioCardia holds positive preliminary consultation with Japan’s PMDA - Investing.com



BioCardia holds positive preliminary consultation with Japan’s PMDA  Investing.com

BioCardia’s Positive Consultation with Japan’s PMDA - TipRanks



BioCardia’s Positive Consultation with Japan’s PMDA  TipRanks

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 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  Stock Titan

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)

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



Korea, Japan ink medical device info sharing pact  BioWorld MedTech

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation wit...



BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA  The Manila 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

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

Plutonium Management and Disposition Agreement (PMDA), Aim, Latest News - Vajiram & Ravi



Plutonium Management and Disposition Agreement (PMDA), Aim, Latest News  Vajiram & Ravi

New Horizon in Clinical Development Strategy in Japan Based on New Guideline on Japanese Phase 1 ...



New Horizon in Clinical Development Strategy in Japan Based on New Guideline on Japanese Phase 1 Studies Prior to Multi-Regional Clinical Trials  Wiley

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

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

Asia-Pacific Roundup: CDSCO seeks feedback how to ensure a level playing field for drug approvals...



Asia-Pacific Roundup: CDSCO seeks feedback how to ensure a level playing field for drug approvals  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

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

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

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

Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec - Business Wir...



Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec  Business Wire India

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

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

Jurisdiction row: Addl chief secy for better coordination - Times of India



Jurisdiction row: Addl chief secy for better coordination  Times of India

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

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



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

FDA, Japan's PMDA strengthen ties to accelerate regulation processes - Philippine News Agency



FDA, Japan's PMDA strengthen ties to accelerate regulation processes  Philippine News Agency

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

Japan PMDA opens second overseas office in Washington - BioWorld MedTech



Japan PMDA opens second overseas office in Washington  BioWorld MedTech

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

Where The FDA And EMA Stand On Digital Endpoints - Clinical Leader



Where The FDA And EMA Stand On Digital Endpoints  Clinical Leader

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

Regulatory cooperation to improve global health - European Medicines Agency



Regulatory cooperation to improve global health  European Medicines Agency

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

Two decades of new drug approvals in Japan - Nature



Two decades of new drug approvals in Japan  Nature

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



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

Asia-Pacific Roundup: Japan’s PMDA translates advice on using e-consent technologies in clinical ...



Asia-Pacific Roundup: Japan’s PMDA translates advice on using e-consent technologies in clinical trials  Regulatory Affairs Professionals Society | RAPS

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

BioCardia, Inc. Completes Consultation with Japan's PMDA on BCDA-01 for Ischemic Heart Failure Tr...



BioCardia, Inc. Completes Consultation with Japan's PMDA on BCDA-01 for Ischemic Heart Failure Treatment  Quiver Quantitative

Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections - Regulatory Aff...



Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections  Regulatory Affairs Professionals Society | RAPS

Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline - Regulatory Affairs ...



Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline  Regulatory Affairs Professionals Society | RAPS

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

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

PMDA CEO K. Makarand Pandurang conducts surprise inspection of Panchkula city - The Impressive Times



PMDA CEO K. Makarand Pandurang conducts surprise inspection of 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

Op-ed: PMDA advances regulatory science-based “rational medicine” - Foreign Policy



Op-ed: PMDA advances regulatory science-based “rational medicine”  Foreign Policy

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



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

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

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



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

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



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

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 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

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

Breaking the speed: Pkl’s new tabletop plan aims to slow things down - Times of India



Breaking the speed: Pkl’s new tabletop plan aims to slow things down  Times of India

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

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

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



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

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



JAPAC Drug Development: Navigating Safety & Regulatory Requirements  HIT Consultant

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

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

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

Lecanemab Receives Priority Review Status in Japan - Biogen



Lecanemab Receives Priority Review Status in Japan  Biogen

PMDA issues rains alert for September 16-19 - Associated Press of Pakistan



PMDA issues rains alert for September 16-19  Associated Press of Pakistan

Medic Vision Wins Japanese PMDA Clearance for iQMR Image Reconstruction Solution - Imaging Techno...



Medic Vision Wins Japanese PMDA Clearance for iQMR Image Reconstruction Solution  Imaging Technology News

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

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



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

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



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

Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemch...



Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemchymal® SCA in the Treatment of Spinocerebellar Ataxia in Japan  BioInformant

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