知識管理專區--投資中國生技醫藥產業之策略地圖
2012-05-25
知識管理專區
投資中國生技醫藥產業之策略地圖
Strategy Map of investing in China Biotech Industry
1.國家醫藥相關科技政策
Related National policies on science and technology
●國家中長期科學和技術發展規劃綱要
National middle and long-term scientific and technological development program outline
●醫藥科學技術政策 ( 2002-2010 )
Medical Science and Technology Policy (2002-2010)
●國務院 2006 年工作要點
The State Council’s focus in 2006
2.GMP-GLP-GSP-GCP
●藥物化妝品相關法規條例品質管制規範
Laws and regulations about drug-related cosmetic's quality control
●藥品生產品質管制規範認證
Producing standardized quality control certification of Pharmaceuticals
●藥品經營品質管制規範認證
conducting standardized quality control certification of pharmaceuticals
3.中藥材及其飲片相關檔案
Slices of Chinese herbal medicines and their associated files
●中藥品種保護條例
Medicine Variety Protection Ordinance
●中華人民共和國中醫藥條例 2003-04-07
People's Republic of the Chinese Medicine Ordinance 2003-04-07
●中藥飲片注冊管理辦法 ( 試行 )
TCM registered management practices (Trial)
●中藥材生產品質管制規範 (GAP)
Quality control standards of Chinese herbal medicine producing (GAP)
●野生藥材資源保護管理條例
Natural herbs resources protection and management regulations
●國家重點保護野生藥材物種名錄
National natural Chinese herbs protection Directory
●實施批準文號管理的中藥飲片
First approved Chinese herbs
4.SFDA法律法規及解讀
SFDA interpretation of laws and regulations
● 藥品管理法
Drugs Act
● 處方藥與非處方藥的分類管理制度
Prescription drugs and non-prescription drugs classification management system
● 藥品注冊管理辦法及附屬應用程式
Drugs registered management practices and ancillary applications
● 保健食品相關法律法規
health care food related laws and regulations
● 網際網路藥品訊息服務管理辦法及附屬應用程式
Internet Drugs information service management approach and ancillary applications
● 藥品說明書及標籤管理規定及相關內容
Drugs manuals and labeling regulations and related content
● 藥品不良反應報告
Adverse Drug Reaction Reports
● 行政許可
Administrative licensing
● 醫療器械
Medical Devices
● 特殊藥品
Special Drugs
● 藥品廣告
Drugs Advertising
● 藥品價格
Drugs pricing
5.化妝品相關法規條例
Cosmetics laws and regulations
6.新藥監測期
New medicine's monitor period
7.醫保目錄及支出
Catalog and Medicare expenditures
● 基本醫療保險制度
Basic medical insurance system
● 城鎮職工基本醫療保險用藥範圍管理暫行辦法
The Interim Measures of basic medical insurance in towns and cities
● 中國基本醫療保險及工傷保險藥品目錄
Drugs Content of China's basic medical insurance and industrial injury insurance
● 城鎮職工基本醫療保險定點零售藥店管理暫行辦法
Interim Measures of basic medical insurance about retail pharmacies
8.投資醫療機構之最新法規及未來趨勢
The latest regulations of Investment in medical institutions and future trends
● 醫療機構管理條例
Medical institutions Management Ordinance
●醫療機構管理條例實施細則
Implementation details of medical institutions Management Ordinance
●中華人民共和國執業醫師法
People's Republic of China Medical Practitioners Act
●中外合資合作醫療機構管理暫行辦法
Sino-foreign cooperative medical institutions Interim Measures
9.生技與醫藥產品之進出口報關法之相關法規及執行程式
Biotechnology and pharmaceutical products’ import and export
declarations with relevant laws and regulations and enforcement program
●藥品進口管理辦法
Drugs import management approach
●藥品加工出口管理規定
Drugs export processing regulations
●中華人民共和國進出口關稅條例
The People's Republic of China tariff
●關於進口藥品通關口岸管理事宜的公告 (2004-05-01)
On imported drugs in customs clearance in ports management notice (2004-05-01)
●進口藥材管理辦法
Import medical materials management approach
10.合同法及法律案件
Contract law and the legal case
●中華人民共和國合同法
PRC Contract Law
●關於合同中約定不明的案例分析
Case analysis of unclear parts in contract
●委托開發合同範本
Commissioned the development of model contracts
●技術轉讓合同範本
Technology transfer model contracts
●技術開發合同範本
Technology development contracts model
11.商標法與知識產權及相關刑事民事案件及代理機構
Trademark law and legal cases about intellectual property rights and
agencies
●中華人民共和國商標法
People's Republic of China Trademark Law
●中華人民共和國商標法實施條例
Regulations for the Implementation of the Trademark Law
●上海商標代理機構名錄
Shanghai trademark agency directory
12.三資企業法規及代理機構及醫藥三資企業經營模式
Laws about Sino-foreign joint ventures and its agents and the business
model of Sino-foreign joint ventures
● 中華人民共和國外資企業法 ( 修改後 )
People's Republic of China Foreign Enterprise Law (revised)
● 中華人民共和國外資企業法實施細則 _ ( 修改後 )
Implementation of the Law of the People'sRepublic of foreign rule(revised)
● 中華人民共和國對外貿易法 (2004 年修訂 )
People's Republic of China Foreign Trade Law (2004 Amendment)
● 外商投資產業指導目錄
Industrial Catalog for Foreign Investment
● 台灣同胞投資企業協會管理暫行辦法
Taiwan Compatriots Investment Enterprises Association's Interim Measures
● 中華人民共和國台灣同跑投資保護法
Laws on the Protection of Investment from Taiwan Compatriots
● 中華人民共和國台灣同胞投資保護法實施細則
Implementation details of Laws on the Protection of Investment from Taiwan Compatriots
● 中華人民共和國中外合資經營企業法
People's Republic of China Foreign Equity Joint Venture Law
● 中華人民共和國中外合資經營企業法實施條例
Implementation details of People's Republic of China Foreign Equity Joint Venture Law
● 中華人民共和國中外合作經營企業法
People's Republic of China Foreign Contractual Joint Venture Law
● 中華人民共和國中外合作經營企業法實施細則
Implementation details of People's Republic of China Foreign Contractual Joint Venture Law
13.生技與醫藥產品註冊訊息服務機構及其經營模式
Biotechnology and pharmaceutical products registered information service
agencies and their business model
14.連鎖經營經營模式
Chain management model
●藥品零售連鎖企業有關規定
Relevant laws about drugs retail enterprises
15.高齡化社會生技醫藥產業發展方向
Biotech industry development direction in Aging society
16.醫療器材復合式及家庭式商機及趨勢及經營模式
Complex medical equipment and family business, trends, and its
opportunities & business model
17.中國生技產業之代工契機與原則
Biotechnology industries of China OEM opportunity and principles
18.中國納米醫藥技術之發展政策及未來趨勢分析
China's Nano-medicine technology development policy and the future t
rend analysis
19.中藥材進出口公司及中藥期貨經營樣式
Traditional Chinese medicine and Chinese herbal medicine import and
export companies operating modes
20.專利法及與生技醫藥產業有關法律案件及代理機構
Patent law , biotechnology and pharmaceutical industries related legal cases
and agencies
● 中華人民共和國專利法
Patent Law of the PRC
● 中華人民共和國專利法實施細則
Implementation Rules of the Patent Law
● 藥品行政保護條例
Implementation Rules
● 藥品行政保護條例實施細則 ( 新 )
Implementation Rules of Implementation Rules (new)
● 中藥品種保護條例
TCM Protection Ordinance
● 新藥保護和技術轉讓的規定 1999-05-01
New drug protection and technology transfer regulation 1999-05-01
●上海市專利代理機構
Patent agencies in Shanghai
21.直銷市場
Direct selling market
● 直銷管理條列
Direct selling management
22.醫藥相關國家主管單位目錄
Relevant Medicine authorities
23.中國醫藥科技出版社出書目錄
China Medicine and Technology Publishing House's book catalg
24. 06年醫藥行業預測
Pharmaceutical industry forecast of 2006
25.台灣相關法律
Taiwan relevant laws
● 中華人民共和國台灣同胞投資保護法
People's Republic of China Law on the Protection of Investment from Taiwan Compatriots
● 中華人民共和國台灣同胞投資保護法實施細則
Implementation details of People's Republic of China Law on the Protection of Investment from Taiwan Compatriots
● 台灣同胞投資企業協會管理暫行辦法
Taiwan Compatriots Investment Enterprises Association's Interim Measures
26.新藥保護期的確定完整版
Identify new drugs protection regulation in full version
● 新藥申報流程及資料
New drug reporting process and related materials
● 藥品註冊
Drugs Registration
● 專利侵權判定
Patent infringement judgment
● 中藥和保健品研究、實踐與發展
Chinese medicine and health products research, practice and development
● 中藥飲片研究的一般程序
General procedures of study of Chinese Herbal Pieces
● 國外的醫藥網站
Foreign pharmaceutical Site
27.其他相關中國藥業資訊
Other relevant information of Chinese medicine industry
● 對《藥品管理法》和《藥品注冊管理辦法》中的重點
Focus of "Drugs Act" and "drug registration procedures"
● 2005 全年和2006 年至今SFDA 所批準的藥品訊息
SFDA approved drugs message from 2005 to 2006
● 未來8 年內即將到期的部分重點藥品
Some important drugs will be expired in following 8 years
● 關於新藥技術轉讓問題 ,大陸的權威評論文章和一個案例
Issues on new drugs' technology transfer, Mainland's authorities discussion articles and one case
● 關於廣義健康產業 , 按照電子商務、娛樂休閒和保險等三個方面的論文集
On health industry in broad sense, collection according to e-commerce, leisure and entertainment and insurance of three aspects
● 大陸醫藥法律和行政組織架構的簡圖
Chinese Medicine laws and administrative organizational structure diagram
● 目前80/20 法則與進出口方面的資料分析
Current 80/20 rules and regulations with regard to import and export data analysis
● 大陸藥品研究機構(CRO)的上、中、下遊層次整體分析報告
Analytical reports of mainland pharmaceutical research organizations (CRO) the upper, middle and lower reaches
● 2004~2005國民經濟白皮書，醫藥產業分析研究報告和保健品行業分析研究報告
Analytical reports of 2004 -2005 the national economy white paper, pharmaceutical industry analyst research reports and health products industry analyst research
● 醫保藥價名單和一些大陸常用藥價格的清單，及價格分析
Medicare drug prices and list prices of some of the commonly used drug list, and price analysis
● 關於中藥材在化妝品上的具體規範 , 僅找到套用的中藥材和部分已經產業化的商品
Specific norms about cosmetics' TCM , apply only to find the Chinese herbal medicines and some industrial commodities have
