"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...

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...

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 ...

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

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

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...

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...
