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市場調查報告書
日本的藥價，回本，法規的最新資訊
Japan: Pricing, Reimbursement and Regulatory Update
| 出版商 |
Datamonitor |
| 出版日期 |
2011年11月 |
商品編碼 |
229442 |
| 內容資訊 |
英文 Pages: 18 |
| 價格 |
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日本的藥價，回本，法規的最新資訊 是由出版商Datamonitor在2011年11月所出版的。
這份英文市場調查報告書包含Pages: 18 價格從美金1900起跳。
日本獎勵創新是最優先事項，2011年政府引進各種的獎勵策略，有許多都對製藥企業產生正面的影響。可是，需要抑制日本的醫療制度所造成的費用增加，政府引進售價和仿製藥的回本政策。
本報告提供日本為促進創新政府所導入的各式各樣的獎勵策略，2011年引進的成本控制策略等相關詳細內容調查·分析，為您概述為以下內容。
第1章 執行摘要
- 簡介
- 策略性調查和焦點
- Datamonitor的主要結果
- 日本致力於新藥核准的延遲
- 努力支持創新的政府
- 成本控制依然是日本的優先事項
第2章 藥價，回本，法規的最新資訊
- 2011年為新藥認症所苦的日本
- 抑制新藥認症延遲的政府的積極推動
- 針對日本疫苗延遲的政府
- 政府為了促進創新而引進多種的獎勵策略
- 衛生署的超便攜式孤兒藥支援的新系統的實現
- 國內未核准醫藥品企圖速度化的進入系統的提案
- 醫藥品如果包含批準的藥品和相同的有效成分，最高法院的決定是延長專利期限
- 小兒科使用系統的附加費用為了促進小兒科革新預計將變更
- 成本控制依然是2011年日本的優先事項
- 「混合醫療」的回本在2011年禁止
- 2011年4月的長期上市商品價格影響產品線成熟的企業
- 以學名藥品降價為目標的政府
第3章 參考文獻
第4章 附錄
Description
Introduction
Stimulating innovation is a top priority in Japan, with the government having brought in a range of incentives in 2011, many of which will have a positive impact on pharma. However, the escalating costs incurred by the Japanese healthcare system need to be curtailed, and consequently the government has brought in measures to cut the price and reimbursement of generic drugs.
Features and benefits
- Insight into the range of incentives the government is bringing in to encourage innovation in Japan
- Examines Japan's cost-containment measures introduced in 2011
Highlights
- Moves by the government to reduce the drug-lag and increase innovation are paying off. A wide range of products for serious diseases across various therapeutic areas including oncology, cardiovascular diseases, and infectious diseases were submitted for regulatory approval in 2011.
- In 2011, Japan brought in incentives to stimulate innovation, including supporting ultra-orphan drug development; granting patent-term extensions even when drugs have the same active ingredients as currently approved drugs; and changing the system by which pharmaceutical companies are awarded price premiums for developing drugs for pediatric use.
- Cutting costs remain at the top of the Japanese government's agenda as pressure on its healthcare system intensifies. In preparing its 2012 budget, the government in August 2011 indicated that annual spending needed to be reduced and it plans to cut healthcare costs via price cuts and encouraging generics uptake.
Your key questions answered
- Evaluate the key pricing, reimbursement, and regulatory issues in the Japan and their impact on branded pharmaceutical market access and uptake.
- Gain insight into the strategies employed by pharmaceutical companies in response to changes in the regulatory environment.
TOC
Executive Summary
- Introduction
- Strategic scoping and focus
- Datamonitor key findings
- Japan is tackling its drug lag
- The government is attempting to encourage innovation
- Cost-containment remains a priority in Japan
PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
- Japan has tackled its drugs lag in 2011
- Government initiatives to reduce drug lag
- The government has been addressing the vaccines lag in Japan
- The government is bringing in a range of incentives to encourage innovation
- MHLW to implement a new system to support ultra-orphan drugs
- Access system to speed up domestically unapproved drugs proposed
- Supreme Court rules for patent-term extensions to be granted when drugs have the same active ingredient as approved drugs
- Premiums on pediatric use system could be changed to encourage pediatric innovation
- Cost-containment remains a priority in Japan in 2011
- Reimbursement of "mixed healthcare" in Japan was banned in 2011
- Prices of long-listed drugs in April 2011 affect companies with mature portfolios
- Government seeks to reduce prices of generic drugs
BIBLIOGRAPHY
- Publications and online articles
APPENDIX
- Exchange rates used in this report
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