Japan Pharmaceuticals And Medical Devices Agency (pmda) - Pharma

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Relevant Publications

Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles.

Issue Release: 2024

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

Issue Release: 2024

The Impact of Regulatory Reforms in China on Drug Lag: The Role of Clinical Development Strategies.

Issue Release: 2024

Concordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.

Issue Release: 2024

Therapeutic applications of carbohydrate-based compounds: a sweet solution for medical advancement.

Issue Release: 2024

Postmarket safety communications on drugs approved in Japan: A 25-year analysis.

Issue Release: 2024

Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.

Issue Release: 2024

Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.

Issue Release: 2024

Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.

Issue Release: 2024

A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.

Issue Release: 2024

A Sponsor\'s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan.

Issue Release: 2024

Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan.

Issue Release: 2024

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

Issue Release: 2024

Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.

Issue Release: 2023

A new era of the Asian clinical research network: a report from the ATLAS international symposium.

Issue Release: 2023

Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan.

Issue Release: 2023

Insights into the clinical development of regenerative medical products through a comparison of three cell-based products recently approved for limbal stem cell deficiency.

Issue Release: 2023

Analysis of Corticosteroid-Induced Glaucoma Using the Japanese Adverse Drug Event Reporting Database.

Issue Release: 2023

Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan.

Issue Release: 2022

Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia.

Issue Release: 2022

What Role Do Pharmacists Play in Patient Education?

What Role Does Cellular Stress Play in Disease?

How Can Cellular Stress Be Measured?

What Challenges Exist in Patient Education?

What Should Be Included in Patient Education Materials?

What are Collaborative Care Models?

How Does Pharma Play a Role in Chronic Conditions?

What Education and Training Do Pharmacists Need?

What are the Challenges Faced by Generic Manufacturers?

How Long Does the Approval Process Take?

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