"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

Interview with MHLW and PMDA leadership - Food and Drug Administration (.gov)



Interview with MHLW and PMDA leadership  Food and Drug Administration (.gov)

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



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

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



Eisai seeks PMDA approval for subcutaneous Leqembi in Japan  Pharmaceutical Technology

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

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

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



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

Nadofaragene firadenovec under regulatory review in Japan - Urology Times



Nadofaragene firadenovec under regulatory review in Japan  Urology Times

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



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

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 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

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



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

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

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

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

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 discusses changes to warning letters - Regulatory Affairs Professional...



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

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

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

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

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



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

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



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

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

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



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

Sony’s Mike Kahn elected PMDA president - Imaging Resource



Sony’s Mike Kahn elected PMDA president  Imaging Resource

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)

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



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

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



Korea, Japan ink medical device info sharing pact  BioWorld MedTech

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

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

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



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

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

Regulatory round-up: 29 October 2025 - The Pharma Letter



Regulatory round-up: 29 October 2025  The Pharma Letter

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

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

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

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

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

ICH M12 2024 vs EMA 2013 DDI Guidance. What’s New? - Evotec



ICH M12 2024 vs EMA 2013 DDI Guidance. What’s New?  Evotec

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

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

Japan PMDA opens second overseas office in Washington - BioWorld MedTech



Japan PMDA opens second overseas office in Washington  BioWorld MedTech

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

Ami Organics' Unit II receives Japan PMDA nod for GMP compliance - Capital Market



Ami Organics' Unit II receives Japan PMDA nod for GMP compliance  Capital Market

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

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

Biocon Biologics debuts its psoriasis biosimilar in Japan - ET Pharma



Biocon Biologics debuts its psoriasis biosimilar in Japan  ET Pharma

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

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

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

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

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



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

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

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



JAPAC Drug Development: Navigating Safety & Regulatory Requirements  HIT Consultant

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

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

Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency f...



Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval  Business Wire

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

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



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

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

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

PMDA CEO Pandurang conducts surprise inspection of Panchkula city - Punjab Newsline



PMDA CEO Pandurang conducts surprise inspection of Panchkula city  Punjab Newsline

Japan Recommends Approval Of Brukinza, Balversa - Citeline News & Insights



Japan Recommends Approval Of Brukinza, Balversa  Citeline News & Insights

Japanese pharmaceutical regulations under review to resolve drug shortages and ensure stable supp...



Japanese pharmaceutical regulations under review to resolve drug shortages and ensure stable supply  Endpoints News

Companion Diagnostics Regulations are Evolving in Asia - MedTech Intelligence



Companion Diagnostics Regulations are Evolving in Asia  MedTech Intelligence

Biocon share rises 4% as arm gets Japan's PMDA approval for Psoriasis drug - Business Standard



Biocon share rises 4% as arm gets Japan's PMDA approval for Psoriasis drug  Business Standard

Visualising PCP Metrics Using Grafana - Oracle Blogs



Visualising PCP Metrics Using Grafana  Oracle Blogs

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

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

Has risk management plan system influenced the speed of package insert revisions in Japan? - Fron...



Has risk management plan system influenced the speed of package insert revisions in Japan?  Frontiers

Japanese guidelines for biosimilars - Generics and Biosimilars Initiative



Japanese guidelines for biosimilars  Generics and Biosimilars Initiative

Rs 182-cr world-class shooting range in Panchkula soon - Times of India



Rs 182-cr world-class shooting range in Panchkula soon  Times of India

The RECELL® System Receives PMDA Approval in Japan and - GlobeNewswire



The RECELL® System Receives PMDA Approval in Japan and  GlobeNewswire

Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council Se...



Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council Seeks Additional Data; Aducanumab Remains under Review  Biogen