HOME > REGULATORY
REGULATORY
- MHLW Proposes New Fee for Medical Management of Treatment-Resistant Schizophrenia
January 16, 2012
- MHLW Director Tawaragi Raises 3 Points, Including Risk Management Planning, as Priority Measures for FY2012
January 13, 2012
- MHLW to Strengthen Support for Ultra-Orphan Drug Development
January 13, 2012
- PFSB Calls for Revision of Package Inserts for 15 Products
January 12, 2012
- MHLW Revises Ministerial Ordinance to Prohibit Dispensing Point Services by Pharmacies
January 12, 2012
- MHLW Issues Administrative Notification on Reexamination Period for 8 Products Approved After Partial Changes
January 11, 2012
- MHLW Issues Notification on Change in Clinical Trial Protocols
January 11, 2012
- Nicotine Patch Products Should Remain Class 1 OTC Drugs: PAFSC Subcommittee
January 11, 2012
- JPO Amends Patent Examination GL to Allow Patent Extension for New Formulations Containing Existing APIs
January 10, 2012
- EC Approves Revised Product Labeling for Actos: Takeda
January 10, 2012
- Hyperthyroidism Added to Serious ADR Section of Flolan’s Package Insert
December 28, 2011
- MHLW Commission Says Joint Purchasing an Advantage to Integration of National, Rosai Hospitals
December 28, 2011
- Additional NHI Price Cuts Decided: ¥22.5 Billion for Long-Listed Drugs, ¥2.5 Billion for Generics
December 27, 2011
- PFSB Draft Budget Includes ¥2.1 Bil. to Improve Review, Safety Measures
December 27, 2011
- Reevaluation Recommended for Lysozyme, Pronase
December 26, 2011
- Tougher Restrictions on Reimbursement of Vitamins to Cut ¥15 Bil. from Med. Expenditure
December 26, 2011
- Development Request Withdrawn for Mitoxantrone
December 26, 2011
- Application Based on Data from Public Domain Recommended for 6 APIs Including Amlodipine
December 26, 2011
- ¥25 Bil. to Be Saved through Add’l NHI Price Cuts for Both Long-listed, Generic Drugs in FY2012: MHLW
December 26, 2011
- MIPO to Begin Preparing for Drug Discovery Support Organization
December 26, 2011
ページ
For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
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…