The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
REGULATORY
Panels Agree to Add Risk of Thrombocytopenia to AstraZeneca Vaccine Label
Panels of experts under the Japanese health ministry have agreed to recommend a label revision for AstraZeneca’s COVID-19 vaccine to add “thrombocytopenia” to its adverse reaction list, with the update expected as early as this week. The recommendation was made…
To read the full story
Related Article
- No Major Safety Concerns for COVID-19 Jabs: MHLW Panels
January 24, 2022
- Second Case of TTS with Possible Link to AstraZeneca COVID-19 Vaccine Reported in Japan
December 27, 2021
- Japan Panels Agree to Add Myocarditis as ADRs for Pfizer, Moderna Vaccines
December 6, 2021
- TTS with Possible Link to AstraZeneca COVID-19 Vaccine Reported in Japan
November 15, 2021
- MHLW Panels Continue to See No Major Safety Concerns for COVID-19 Jabs
October 25, 2021
- No Major Safety Concerns for Moderna, Pfizer COVID-19 Vaccines: MHLW Panels
October 4, 2021
- Causal Link between Deaths and Recalled Batch of Moderna Jab “Indeterminable”
September 13, 2021
- No Major Safety Concerns for Moderna, Pfizer COVID-19 Vaccines: MHLW
August 6, 2021
- Label Revisions Ordered for AstraZeneca’s COVID-19 Vaccine; Thrombocytopenia Added to Adverse Reactions
July 28, 2021
- No Major Safety Concerns for Moderna, Pfizer COVID-19 Vaccines: MHLW
July 9, 2021
- No Major Concerns over Safety of Moderna, Pfizer COVID-19 Vaccines: MHLW
June 11, 2021
- MHLW Panels to Analyze Group-Based Data for Post-COVID-19 Vaccination Deaths
May 27, 2021
- No Serious Safety Concerns Detected for Comirnaty: MHLW Safety Panels
May 14, 2021
- Don’t Take Vaccines If You Feel Ill: Safety Panels to Elderly
April 26, 2021
- COVID-19 Vaccine Reactions More Common in Women, Younger People: MHLW Study
April 12, 2021
- Vaccine Safety Panels to Evaluate Suspected Anaphylaxis Cases Based on Pfizer’s Reports
April 12, 2021
- 35.6% of Pfizer Vaccine Recipients Developed Fevers after 2nd Shot, Higher Incidence in Women: MHLW
March 29, 2021
- No Significant Concerns Observed with Pfizer COVID-19 Vaccine: Japan Safety Panels
March 15, 2021
- Site Pain Common with COVID-19 Vaccine, but It Improves in 3 Days: Safety Follow-Up
March 15, 2021
- Japan Confirms 1st Case of Anaphylaxis from COVID-19 Vaccination
March 8, 2021
- Woman Dies 3 Days after COVID-19 Vaccine Shot, but Link Indeterminable
March 3, 2021
REGULATORY
- Three Ministers Agree on Off-Year Drug Price Revision in FY2025
December 20, 2024
- Japan Set to Settle Off-Year Debate with “x1.0” Threshold for PMP Meds/Generics, “x0.5” for LLPs
December 20, 2024
- MHLW Proposes Setting Product Scope for Off-Year Revisions by Category
December 19, 2024
- MHLW to Disclose Company Names under Generic Index Rule Possibly in FY2026
December 19, 2024
- Japan Weighs Tweaking “x0.625” Threshold to Narrow Off-Year Revision Coverage
December 19, 2024
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…
Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…
For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…