Year 2022 Update Information

PIVOT Tie-in Video "& questions｜What kind of innovation will change Japan? is now available.

The following pages are released: "Internal Process Flow for Utilization of the Registry for Drug Applications (From Internal Proposal to Registry Modification).

Q&A on Medical Education Meetings and Medical Booths" was updated.

Guidance for Medical Affairs Department in Providing Medical and Scientific Information" is now available.

The "Direction of the Medical Education Meeting" is now available.

The 46th ICH Immediate Report Meeting (Web-based)" is now available.

The material of "Mini-Seminar on Electromagnetic Compliance" on December 21, 2022 has been added.

"Drug Industry 2022-2023" (in Japanese) is now available.

Newly added "Estimation of Therapeutic Effects of Rare Diseases" is now available.

Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (revised edition of 2022)" is now available.

Issues to be resolved to promote the sharing of clinical trial data" is posted.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Proposals from the Pharmaceutical Industry for the G7 Hiroshima Summit Health Agenda: " is now available.

The 16th Annual Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Introduction of Sequential Multiple Assignment Randomized Trials (SMART)" is now available.

Joint Opinion on the Mid-Year Revision of NHI Drug Prices" by Japan, the U.S., and European pharmaceutical organizations is now available.

Opinion on Access to Digital Sequence Information and Benefit-Sharing" is now available.

JPMA Newsletter No. 212" is now available.

Cabinet Decision on the Second Supplementary Budget for FY2022
～The "JPMA President's Statement" is now available.

Report on the Results of the Questionnaire Survey on the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency - January 2022 Survey -" is now available.

Video presentation on "Partial Amendment of Enforcement Regulations of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices and Enforcement Regulations of the Clinical Research Act - Points to keep in mind regarding post-marketing clinical trials other than post-marketing clinical trials for re-examination and re-evaluation -" (October 27, 2022) is available. Video clips and documents of the meeting (held on October 27, 2022) are now available.

Clinical Trial 119: Q&A update: "Use of Residual Specimens from Clinical Trials for Future Research

The 4th ICH Forum: ICH Efficacy Guideline Update" is now available.

The Office of Pharmaceutical Industry ResearchOPIR Views and Actions No.67" was posted on the website of

Statement by JPMA Chairman on the Cabinet Decision on "Comprehensive Economic Measures to Overcome High Prices and Revitalize the Economy" is now available.

Newspaper Advertisement" is posted.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Study Group on Extending Healthy Life Expectancy and Driving Economic Growth "Accumulation of Domestic and Foreign Research on Disease Prevention - Map of Prior Studies" is now available.

JPMA Code of Practice "Month to Promote Understanding of the JPMA Code of Practice"" is now available.

The "Future of Clinical Research in a Changing World (October 2022)" is now available.

The "Greater Tokyo Biocommunity (GTB): Collaboration among the University of Tokyo, Medical and Dental University, and JPMA in Hongo, Ochanomizu, and Tokyo Station Area" is now available.

IFPMA's VaccinesForLife Campaign Phase2 video is now available.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

The following pages are released: "Current Status and Challenges of DDC/EHR Data Linkage" (Japanese)

Explanation of the "Guidance for Electronic Reporting of Adverse Reactions and Infectious Drug Reactions - E2B(R3) Compliance - (2022 Edition)" is now available.

Election of New Board Members" is available.

JPMA Newsletter No. 211" is now available.

Causal Reasoning for Understanding ICH E9(R1) - Time-Dependent Treatment" is now available.

Video of Phase 2 of the AlwaysInnovation Campaign by IFPMA is now available.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Video of "JPMA Presidents Press Conference Presentation on August 30" is now available.

Clinical Trial 119: Q&A update: "Providing Patient Information to the Sponsor Prior to Obtaining Consent

Clinical Trial 119: Q&A update: "Handling of SAE Reporting for Admission for Scheduled Surgery (Part 4)

JPMA Press Conference on August 30, 2011" is available.

Revised topic "Data Flow in DCT and Ensuring Reliability" is now available.

The following pages are released / Topics for DM innovation: "Efficient DM operations based on Fitness for Purpose" (Japanese only)

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Proposal for the development of a promotion system for vaccines from research and development to practical application and routine vaccination based on the basic strategy for the prevention of infectious diseases (excluding those related to the Pharmaceuticals and Medical Devices Law)" is now available.

Presentation materials for "JPMA Media Forum (July 19, 2022)" are now available.

Drug Evaluation From Now On --- What's the value of local data in the global clinical data package? " is now available.

Causal Inference for Understanding ICH E9(R1)" is posted.

Status of Vaccination and Adverse Reactions" is updated.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Berlin Declaration" by IFPMA is now available.

JPMA Newsletter No. 210" is now available.

Public-Private Partnership for the Control of Neglected Tropical Diseases "Kigali Declaration" Signed" is now available.

The 45th ICH Immediate Report Meeting (Web-based)" is updated.

The following pages are released / updated: "The Direction of MSL" (Japanese only)

Clinical Trial 119: Q&A update: "Attribution of ePRO data

Clinical Trial 119: Q&A update: "Form 2: Custodian of the original list of investigators and collaborators

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Toward Building an Ecosystem to Enhance Japan's Drug Discovery Capabilities" is now available.

The following pages are released: "Points to keep in mind when using Real World Data as an external control in regulatory filings" (Japanese only)

JPMA President's Dialogue: "The Vision for Japan after the New Corona" has been added in the "Journal" category.

The 12th WTO Ministerial Conference on the Agreement on the Exemption from the Obligation to Protect Intellectual Property (TRIPS Weber)

"Examination of Issues for Ensuring Confidence in Post-Marketing Database Surveillance" is now available.

The following pages are released / updated: "Proper Use of Medicines" (Japanese only)

The 12th WTO Ministerial Conference on the Proper Use of Drugs and the Japan Pharmaceutical Manufacturers Association (JPMIA) jointly produced and released an educational video on polypharmacy, "How Many of Your Drugs Are You Taking?

The "Statement by the R&D-Based Pharmaceutical Industry on the Consultation on the Exemption from Intellectual Property Protection Obligations Scheduled for the 12th WTO Ministerial Conference" is now available.

ICH Q2(R2) / Q14: Guideline Workshops on the Draft Guideline "ICH Q2(R2): Analytical Method Validation" and "ICH Q14: Analytical Method Development" reached Step 2" are now available.

ICH E11A: Extrapolation in Pediatric Drug Development" Guideline Workshops" is now available.

Japanese translation of IFPMA proposal "Applying Lessons Learned from COVID-19 to Create a Healthier, Safer, More Equitable World" is available.

JPMA Guide 2022" is now available.

About Transparency Guideline" of "Transparency Guideline for the Relationship between Corporate Activities and Patient Groups" was updated.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

JPMA Newsletter No. 209" is now available.

Proposal by Japan, the U.S., and Europe: Joint Proposal for the Formulation of a "Framework Policy" and a "Growth Strategy"" is now available.

Newspaper Advertisement" is posted.

Newly added "Digital Advertising" is now available.

Discussion on the Exemption from the Obligation to Protect Intellectual Property in the WTO" is now available.

AMED Infectious Disease Drug Discovery Industry-Academia-Government Liaison Committee website is now available.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Briefing Session on Registration of Clinical Trials" on April 20, 2022 has been posted.

The following pages are released: "Points to Keep in Mind Concerning the Protection of Personal Information in Drug Development and Secondary Use of Data".

Guidance for Preparation of Electronic Attached Documents of Ethical Drugs -Corresponding to the Guidelines for Description in 2009 and 2021 - (April 2022 edition)" is posted.

The following pages are released: "Let's learn about 'Pharmaceuticals' and 'Clinical Trials' (audio description)! (Audio description)" is posted.

The "Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) (Version 2)" is now available.

JPMA Recommended Form for Communicating Safety Information to Medical Institutions Conducting Clinical Trials" is now available.

Study to Promote the Utilization of the Registry for Pediatric, Rare and Intractable Diseases" is now available.

Tips for introducing and utilizing Quality Management System in PV" is now available.

IFPMA "AlwaysInnovating Campaign"" is now available.

Data Integrity Regarding Computerized Systems in the GCP Area (for Management)" is now available.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Presentation Material for Pediatric Drug Development Workshop held on March 29, 2022" is now available.

The following pages are released: "Utilization and Requirements for Digital Biomarkers (dBM) in Drug Development" (Japanese only).

AMR Action Fund announced its first investment project.

The report "The Health Crisis of AMR: What We Can Do to Learn from Novel Coronavirus Infections to Counter the Silent Pandemic of Drug Resistance (AMR)" is now available.

Clinical Trial 119: Questions and Opinions" has been updated.

The "11th Asian Pharmaceutical Association Conference (APAC) Press Conference on April 6" is now available.

The following pages are released: "The 11th Asian Pharmaceutical Association Conference (APAC) Press Conference" is now available.

The following pages are released / updated: "Current Status and Issues of eConsent in Drug Development" is posted.

The following pages are released: "Results of Questionnaire Survey on Remote Surveillance (Reexamination Compliance Surveillance) (March 2022)" is posted.

Explanation of Basic Items for Utilization of eTMF (electronic Trial Master File) and TMF Metrics" is posted.

What is required to digitize paper originals of clinical trial-related documents (focusing on the operation of Certified Copy)" is posted.

Business Policy, Business Plan, and Implementation Plan" for FY2022 is now available.

Features of Electronic Certificates Used in the Electronic Data Application System" is now available.

Guidebook for Pharmaceutical Companies to Implement Patient Centricity-based Activities (2022 Edition)" is now available.

Guidebook for Remote Investigation (Reexamination)" (January 2022) is now available.

Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" has been updated.

Newspaper Advertisement" is posted.

The "Data Integrity Declaration Jointly Formulated by Three Organizations for Clinical Trials and Clinical Studies" is now available.

Transparency Guideline English version (revised on January 20, 2022)" is now available.

Questionnaire Survey on Companies' Perception of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency" is posted.

Q&A on "Registration of Clinical Trials" (Version 3) is available.

DATA BOOK 2022" is now available.

JPMA Newsletter No.208" is now available.

J-RMP Maintenance as Seen from Company Case Studies - Proposals for Appropriate Drug Risk Management (March 2022 edition)" is now available.

Information session on "Let's learn about "Drugs" and "Clinical Trials"" on November 27, 2021. Public materials are now available.

YELL for New Drugs", a tie-up with Tokyo Graffiti, is now available.

Videos #5-#8 of "Learning with Pharmacy Student Aoito: Innovation of New Drugs" are now available.

The "Briefing Session on the Revised Pharmaceuticals and Medical Devices Act -Responses, etc. required of pharmaceutical companies based on notices and examples-" held on February 22, 2022 is now available.

The "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act -Impact of the Introduction of Investigational New Drugs on Clinical Trials-" on February 22, 2022 is now available.

Clinical Trial 119: Q&A update: "Wash-out before obtaining consent

DATA BOOK 2022 (Japanese)" is now available.

Presentation materials for "The 10th Data Science (DS) Subcommittee Assembly (Symposium) Part 1" are now available.

Joint Statement on "Three Priorities for Promptly Increasing Access to COVID-19 Vaccine" is now available.

The following pages are released: "Current Status and Considerations for Introducing RPA into PV Operations" (February 2022).

Presentation materials for "The 10th Data Science (DS) Subcommittee Assembly (Symposium) Part 1" are now available.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

JPMA's Video Contents" has been updated.

The "JPMA Communication Plan for FY2021" is now available.

The 105th Assembly of the Clinical Evaluation Subcommittee (Part 2): Considering the Future Pharmaceutical Industry from the Perspective of Advances in Digital Technology" is now available.

Transparency Guideline (Revised on January 20, 2022)" is available.

Workshop for Practitioners on Electronic Data Submission at the Time of Filing Application" (Japanese only) is now available.

JPMA's official Twitter account has been opened.

Videos #1 to #4 of "New Drug Innovation with Aoi, a Pharmacy Student" are now available.

Briefing on eCTD v4.0 (ICH M8) Notification Revision and Start of Operation" is now available.

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Slide book "How to Introduce and Utilize Clinical Trial Methods that Do Not Require Visits to Medical Institutions" is now available.

PMDA Reliability Assurance Department's "GPSP Information Session 2022" is now available.

Matching Adjusted Indirect Comparisons: Is the Population Adjustment Method Useful? -Matching Adjusted Indirect Comparison and Simulated Treatment Comparison-" is posted.

JPMA Press Conference on January 20" is now available.

JPMA Newsletter No. 207" is now available.

Guidance for Remote Investigation (Reexamination)" (January 2022) is now available.

Clinical Trial 119: Q&A update: "Substitution of a Consent Document by a Person Equivalent to a Substitute Consentor

JPMA Chairman's New Year Message for 2022