標(biāo)題: Titlebook: Approaching China‘s Pharmaceutical Market; A Fundamental Guide Ming Q. Lu Book 2015 Springer International Publishing Switzerland 2015 CFD [打印本頁] 作者: Diverticulum 時(shí)間: 2025-3-21 19:51
書目名稱Approaching China‘s Pharmaceutical Market影響因子(影響力)
作者: 引導(dǎo) 時(shí)間: 2025-3-21 20:15 作者: 比賽用背帶 時(shí)間: 2025-3-22 00:27 作者: jagged 時(shí)間: 2025-3-22 05:40
Registration,rketed in any country, while Class 3 refers to a new drug that has been marketed outside of China, but not in China market yet. For import drug registrations, if the manufacturers are located outside of mainland China, they have to follow the drug application pathway of Import Drug Registration. The作者: 賄賂 時(shí)間: 2025-3-22 08:53 作者: ENACT 時(shí)間: 2025-3-22 15:09 作者: 享樂主義者 時(shí)間: 2025-3-22 20:53 作者: dainty 時(shí)間: 2025-3-22 22:27 作者: 射手座 時(shí)間: 2025-3-23 01:37 作者: 導(dǎo)師 時(shí)間: 2025-3-23 06:12
rn companies aspiring to expand into China’s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future978-3-319-36571-8978-3-319-15576-0作者: theta-waves 時(shí)間: 2025-3-23 10:32
Erfolgreiche Strategiearbeit im Mittelstand of the articles that are most relevant to overseas pharmaceutical companies, and the major regulations related to drug registration, quality management, and inspection. The corresponding guidances are listed and will be discussed in the corresponding independent chapters.作者: 要求比…更好 時(shí)間: 2025-3-23 16:39
Erfolgreiche Strategien für E-Commerceese State Council in 2008. In this chapter, we’ll briefly introduce the basic knowledge of the Chinese IPR system, the key regulatory policies, and the differences between China and western countries. We hope this section for Pharmaceutical Patent Protection may help overseas and multinational pharm作者: Bouquet 時(shí)間: 2025-3-23 18:34
Unternehmensführung & Controllingt ones for multinational pharmaceutical companies and pharmacy school students to understand. We hope this chapter may help the readers get a basic idea of China’s regulatory environment through the understanding of the CFDA structure and function and its differences from its counterparts in the wes作者: 誤傳 時(shí)間: 2025-3-24 02:05 作者: 預(yù)示 時(shí)間: 2025-3-24 03:00 作者: 許可 時(shí)間: 2025-3-24 06:41
https://doi.org/10.1007/978-3-8350-9511-3ous clinical phases have to follow the CFDA’s defined requirements; the investigator’s responsibilities and safety reporting requirements are very unique from those of the western world; all the clinical sites and investigators have to be certified by the CFDA to conduct the clinical trials; all eth作者: 浸軟 時(shí)間: 2025-3-24 11:51
Ergebnisse der empirischen Untersuchung,ug registration in China, IMCT data shall be in line with the requirements of the CFDA regulations. In this section, we’ll introduce the development strategies with a focus on IMCT, its subtypes, the corresponding advantages and disadvantages of each potential pathway, the application processes, the作者: 尾巴 時(shí)間: 2025-3-24 16:28 作者: 腐蝕 時(shí)間: 2025-3-24 20:15 作者: LEERY 時(shí)間: 2025-3-25 02:29 作者: 虛弱 時(shí)間: 2025-3-25 03:23 作者: legislate 時(shí)間: 2025-3-25 10:19 作者: ARCHE 時(shí)間: 2025-3-25 12:30
Guidance for Application Materials/Booklets (Chemical), definitions and dossier application requirements for various drug categories and classes in the acceptance, review, approval, and overall registration processes. The regulation also clarifies the requirements for source data review, criteria for on-site inspection and product quality inspection. Si作者: 罵人有污點(diǎn) 時(shí)間: 2025-3-25 17:29 作者: FEIGN 時(shí)間: 2025-3-25 22:59 作者: 新字 時(shí)間: 2025-3-26 01:10
Strategic Drug Development in China and Surrounding Countries, register their investigational drugs in China. Companies favor IMCT since it allows sharing of global drug development resources, synchronizes global drug research and development processes, reduces cost by avoiding unnecessary repetition of clinical trials, and shortens the time gaps in drug marke作者: IST 時(shí)間: 2025-3-26 05:52
Drug Safety Monitoring and Reporting Systems in China, West’s, making it harder for multinational companies to run their clinical trials and manage their marketed drugs. In this chapter, we will briefly review the history of safety-related regulations, current safety-monitoring regulations, and reporting requirements for the investigational drugs in th作者: Mendicant 時(shí)間: 2025-3-26 09:06 作者: ANTH 時(shí)間: 2025-3-26 16:27
Book 2015 patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registr作者: exceptional 時(shí)間: 2025-3-26 20:15
Chinese State Food and Drug Administration (SFDA) and the C?This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce 作者: Grating 時(shí)間: 2025-3-26 21:42
Erfolgreiche Strategien für E-Commerce:.Because most controversy and misunderstanding of safety topics are related to the clinical trial stages, we’ll focus on clarifying clinical trial safety management, especially safety monitoring and reporting regulations for corresponding procedures.作者: 鳴叫 時(shí)間: 2025-3-27 02:00 作者: FAR 時(shí)間: 2025-3-27 06:47
Erfolgreiche Strategien für E-Commerceand Labels and other regulations. In this chapter, we’ll use Class I chemical drug as an example to introduce the preparations for each of the 32 items/booklets in combination with the corresponding guidelines, as well as the comparisons with CTD contents.作者: JADED 時(shí)間: 2025-3-27 12:42
Guidance for Application Materials/Booklets (Chemical),and Labels and other regulations. In this chapter, we’ll use Class I chemical drug as an example to introduce the preparations for each of the 32 items/booklets in combination with the corresponding guidelines, as well as the comparisons with CTD contents.作者: Nomadic 時(shí)間: 2025-3-27 15:18
Ming Q. LuAddresses the key issues for multinational pharmaceutical companies looking to market their drugs in China.Highlights the regulations of the Chinese State Food and Drug Administration (SFDA) and the C作者: Buttress 時(shí)間: 2025-3-27 18:26 作者: ingestion 時(shí)間: 2025-3-28 00:04
https://doi.org/10.1007/978-3-319-15576-0CFDA; FDA; drug management law; investigational drug; regulatory guidance作者: Stress 時(shí)間: 2025-3-28 05:50
978-3-319-36571-8Springer International Publishing Switzerland 2015作者: Wordlist 時(shí)間: 2025-3-28 06:55
Erfolgreiche Strategiearbeit im Mittelstandal, and economic discrepancies, foreign pharmaceutical companies hoping to introduce their drugs to the Chinese market have met many challenges and difficulties. China’s pharmaceutical laws and regulations are the legal norms that encompass unique social and economic relations during the national dr作者: 貨物 時(shí)間: 2025-3-28 11:39
Erfolgreiche Strategien für E-Commerceandards for pharmaceutical IPR protection. At the same time, China also issued a series of national regulatory policies to encourage domestic drug innovations (Ding, J Technol Manage Innov 6(2):1–13, 2011) . Therefore, both those policies for incentive innovations and the IPR laws have played import作者: Project 時(shí)間: 2025-3-28 17:41 作者: 使厭惡 時(shí)間: 2025-3-28 20:44 作者: 預(yù)示 時(shí)間: 2025-3-29 00:35
