Year 2022 Update Information

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

Internal Process Flow for Utilizing the Registry for Drug Applications, etc. (From Internal Proposal to Registry Modification)" is now available.

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 Therapeutics and Vaccines" is updated.

The newest version of "Pharmaceutical Industry Recommendations for the Health Agenda of the G7 Hiroshima Summit" is available.

The 16th Annual Survey on Consumer Awareness of Drugs and the Pharmaceutical Industry

Status of Approval and Development of Therapeutics and Vaccines" is updated.

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.

Pharmaceutical Manufacturers Association of Japan Newsletter No. 212" is now available.

Cabinet Decision on the Second Supplementary Budget for FY2022
～Statement by the President of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

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 from 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 "Policy Research Institute News No.67" is available on the website of the Pharmaceutical and Industrial Policy Research Institute (PIRI).

Statement by the President of the Pharmaceutical Manufacturers Association of Japan (PMAJ) on the Cabinet Decision "Comprehensive Economic Measures to Overcome High Prices and Revive the Economy" is now available.

Newspaper Advertisement" is now available.

Status of Approval and Development of Therapeutics and Vaccines" is updated.

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

The following pages are released / "The Pharmaceutical Association of Japan Code of Practice "Code Understanding Promotion Month"" is released.

The following pages are released / "The Future of Clinical Research in Japan (October 2022)" is now available.

The "Greater Tokyo Biocommunity (GTB) Hongo, Ochanomizu, and Tokyo Station Area: Collaboration between the University of Tokyo, the Medical and Dental University, and the Pharmaceutical Cooperative Association" is now available.

IFPMA's VaccinesForLife Campaign Phase2 video is now available.

Status of Approval and Development of Therapeutics and Vaccines" is updated.

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

Guidance for preparation of electronic adverse drug reaction/infection case reports-E2B(R3)-(2022 Edition, Commentary)" is now available.

Election of New Board Members" is available.

The "Pharmaceutical Manufacturers Association of Japan 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 Therapeutics and Vaccines" is updated.

Video of the August 30th Pharmaceutical Association of Japan Press Conference Presentation" 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)

Presentation Material for the Pharmaceutical Association of Japan Press Conference held on August 30" 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 Therapeutics and Vaccines" is 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 "Pharmaceutical Cooperative Media Forum (July 19, 2022)" are now available.

The following pages are available: "Drug Evaluation in the Future: What is the Significance of Japanese Data in International Joint Development? -" is now available.

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

Immunization Status and Adverse Reactions" was updated.

Status of Approval and Development of Therapeutics and Vaccines" is updated.

IFPMA's "Berlin Declaration" is now available.

Pharmaceutical Cooperative 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 Therapeutics and Vaccines" is 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)

Article: "The Vision for Japan after the New Corona" has been added in the "Journal" category.

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

"Examination of Issues to Ensure Confidence in Post-Marketing Database Surveillance" is now available.

Appropriate Use of Drugs" was updated.

The "How Many of Your Drugs Are You Taking?" video on polypharmacy produced and released jointly by the Council for the Proper Use of Drugs and the Japan Pharmaceutical Manufacturers Association (JPMA).

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.

Briefing on the draft guidelines "ICH Q2(R2): Analytical Method Validation" and "ICH Q14: Analytical Method Development" reached in ICHQ2(R2) / Q14: Step 2" is now available.

Briefing on the draft guideline "ICH E11A: Extrapolation in Pediatric Drug Development" is now available.

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

Pharmaceutical Manufacturers' Association Guide 2022" has been released.

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

Status of Approval and Development of Therapeutics and Vaccines" is updated.

Pharmaceutical Manufacturers Association of Japan Newsletter No. 209" is now available.

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

Special site "Discover the Pharmaceutical Industry Experience Project" has been updated.

Newspaper Advertisement" is now available.

Digital Advertising" is now available.

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

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

Status of Approval and Development of Therapeutics and Vaccines" is updated.

Briefing Session on Registration of Clinical Trial Implementation Status" held on April 20, 2022 is now available.

The "Points to Keep in Mind Regarding the Protection of Personal Information in Drug Development and Secondary Use of Data" is now available.

The "Guide for Preparation of Electronic Attachments of Ethical Drugs: Compliance with 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 "Points to Consider when Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) in the RMP (Second Edition)" is now available.

The "Form for Communicating Safety Information to Medical Institutions Conducting Clinical Trials Recommended by the Pharmaceutical Manufacturers Association of Japan" 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 Therapeutics and Vaccines" is 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: "11th Asian Pharmaceutical Association Conference (APAC) Press Conference" is 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.

The following pages are released: "Explanatory Material on Basic Items for Utilization of eTMF (electronic Trial Master File) and TMF Metrics" (Japanese).

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

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

Characteristics 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 Surveillance (Reexamination)" (January 2022) has been added.

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

Newspaper Advertisement" is now available.

"Three Organizations for Clinical Trials and Clinical Studies Jointly Formulate "Data Integrity Declaration"" is added.

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.

Pharmaceutical Manufacturers Association of Japan 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 General Meeting (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 General Meeting (Symposium) Part 1" are now available.

Status of Approval and Development of Therapeutics and Vaccines" is updated.

The "Pharmaceutical Manufacturers Association of Japan (PMAJ) Video Contents" has been updated.

The "FY2021 Communication Plan of the Pharmaceutical Manufacturers Association of Japan" is now available.

The 105th Annual Meeting of the Clinical Evaluation Committee (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.

The following pages are released: "Announcement of the opening of the official Twitter account of the Pharmaceutical Manufacturers Association of Japan (PMAJ)".

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 Therapeutics and Vaccines" is 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.

The "Pharmaceutical Association of Japan Press Conference on January 20, 2011" is now available.

Pharmaceutical Association of Japan 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

New Year's Greetings from the Chairman of the Pharmaceutical Manufacturers Association of Japan, 2022