-
March 31, 2021
Other
The 38th Science Board Meeting
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March 30, 2021
Safety
Revisions of PRECAUTIONS (Cellular and Tissue-based Products): Onasemnogene abeparvovec, posted
-
March 30, 2021
Safety
Revisions of PRECAUTIONS: Magnesium sulfate hydrate/glucose, etc. posted
-
March 23, 2021
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.381
-
March 23, 2021
Other
Chief Executive’s Statement: Utilization of Real World Data - PMDA’s approaches -
-
March 12, 2021
Other
The 4th Subcommittee on Microbiome
-
March 5, 2021
Pub cmt
JP Drafts (March 2021) posted
-
February 18, 2021
Safety
Notification on self-check, posted
-
February 18, 2021
Safety
PMDA Risk Communication (Medical devices Risk Information of ongoing evaluation) :Drug-eluting coronary stent, etc. posted
-
February 16, 2021
Other
Chief Executive’s Statement: Special Approval for Emergency on First COVID-19 Vaccine in Japan
-
February 4, 2021
Events
Seminar on GCP Renovation -Recent Work of ICH and Overview of ICH E6(R3)-
-
January 27, 2021
Other
The 3rd Subcommittee on Microbiome
-
January 26, 2021
Other
The 7th Subcommittee on Computer Simulation
-
January 19, 2021
Int
ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness
-
December 14, 2020
Events
The 7th Thailand-Japan Symposium
-
December 14, 2020
Events
Report of the PMDA-ATC Japanese Pharmacopoeia Webinar 2020 for Thai FDA
-
December 7, 2020
Int
Statement on continuation of vaccine trials
-
December 1, 2020
Int
Statement from Global Medicines Regulators on the Value of Regulatory Reliance
-
November 24, 2020
Other
Chief Executive’s Statement: To Boost Japan-first Medical Product Approvals ~ PMDA Now Looks at Next Steps ~
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November 20, 2020
Int
EMA-FDA and PMDA GCP Pilot Collaboration Report posted
-
November 18, 2020
Events
Report of the PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020
-
November 17, 2020
Other
The 6th Subcommittee on Computer Simulation
-
November 16, 2020
Int
WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines
-
November 16, 2020
Int
ICMRA meeting: COVID-19 Real-World Evidence and Observational studies #4
-
November 13, 2020
Events
Report of the PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020
-
November 5, 2020
Other
The 2nd Subcommittee on Microbiome
-
November 4, 2020
Events
The 2nd Vietnam-Japan Symposium
-
October 12, 2020
Int
PMDA Reveals Principles on Evaluation of COVID-19 Vaccines
-
October 12, 2020
Other
The 5th Subcommittee on Computer Simulation
-
October 6, 2020
Int
PMDA to Offer Free Scientific Advice for COVID-19 Vaccines Development
-
October 1, 2020
Events
Report of the PMDA-ATC Medical Devices Webinar 2020 for Thai FDA
-
September 11, 2020
Other
The 37th Science Board Meeting
-
September 7, 2020
Pub cmt
JP Drafts (September 2020) posted
-
August 24, 2020
Other
The 4th Subcommittee on Computer Simulation
-
August 18, 2020
Other
The 1st Subcommittee on Microbiome
-
August 4, 2020
Int
ICMRA meeting: COVID-19 Real-World Evidence and Observational studies #3
-
August 3, 2020
Int
ICMRA COVID-19 Treatments and Clinical Trials Workshop #2
-
July 10, 2020
Safety
PMDA Alert for Proper Use of Medical Devices (for patients): For patients who use a ventilator, etc. at home and their families or other caregivers, posted
-
July 8, 2020
Other
The 3rd Subcommittee on Computer Simulation
-
June 23, 2020
Other
The 36th Meeting of the Science Board
-
June 19, 2020
Int
ICMRA statement about confidence in vaccine safety and effectiveness (for healthcare professionals)
-
June 19, 2020
Int
ICMRA statement about confidence in vaccines (for the general public)
-
June 5, 2020
Pub cmt
JP Drafts (June 2020) posted
-
June 4, 2020
Int
For Your Access to Japanese Clinical Trial/Clinical Research Information
-
May 20, 2020
Int
ICMRA statement on COVID-19
-
May 14, 2020
JP
JP17 Updated Errata, JP17-1 Errata, and JP17-2 Errata Posted
-
May 13, 2020
Int
First Approval of Antigen Test for COVID-19
-
May 12, 2020
Int
ICMRA meeting: COVID-19 Real-World Evidence and Observational studies #1
-
May 8, 2020
Int
Special Approval for Emergency on Remdesivir for COVID-19
-
April 21, 2020
Int
Four IVDs Approvals for COVID-19 and Response to the Increased Ventilator Demand
-
April 20, 2020
Int
Global regulatory workshop on COVID-19 therapeutic development #1
-
April 10, 2020
Int
PMDA Takes Further Steps to Speed up Clinical Development of COVID-19 Products
-
April 1, 2020
Int
Global regulatory workshop on COVID-19 vaccine development
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