【正文】 I 摘 要 研究背景： WHO 預(yù)認(rèn)證 項(xiàng)目 （ 簡(jiǎn)稱 WHO PQ）是 WHO 對(duì)藥品生產(chǎn)商和藥品質(zhì)量推行的合規(guī)性 認(rèn)證， 其主要目的 是 為 發(fā)展中國(guó)家患者 提供安全、有效和 質(zhì)量可控的基本藥品 ，特別是針對(duì) 世界范圍 重點(diǎn)疾病 如 艾滋 、結(jié)核和瘧疾等領(lǐng)域治療藥物的資格預(yù)審 ，也 是唯一的全球性藥品質(zhì)量保證規(guī)劃 。 通過(guò) WHO PQ 的 藥物清單現(xiàn)已成為國(guó)際機(jī)構(gòu)的藥品采購(gòu)指南，同時(shí)也為越來(lái)越多的國(guó)家采用。我國(guó)為 制藥 大國(guó)，制藥企業(yè) 要想 參與聯(lián)合國(guó)等國(guó)際采購(gòu)， WHO 預(yù) 認(rèn)證 是第一道門檻。 它 是一個(gè)不需用新藥進(jìn)入國(guó)際市場(chǎng)的渠道。中國(guó)很多仿制藥生產(chǎn)企業(yè)可以通過(guò) WHO PQ 進(jìn)入國(guó)際舞臺(tái)，實(shí)現(xiàn) 國(guó)際化。 研究目的： 本文希望通過(guò)研究， 以注射用頭孢曲松為例，幫助中國(guó)化學(xué)仿制藥生產(chǎn)企業(yè)更好地理解 WHO PQ 要求，以便順利通過(guò) WHO PQ，從而加入國(guó)際采購(gòu)行列。 研究方法： 以注射用頭孢曲松為例調(diào)查市場(chǎng)前景，搜集分析 WHO PQ 相關(guān)的法規(guī)政策，對(duì)比中國(guó)化學(xué)仿制藥注冊(cè)、認(rèn)證要求與 WHO PQ 要求，分別從市場(chǎng)前景、法規(guī)政策、技術(shù)要求三方面深入分析通過(guò) WHO PQ 的可行性，并歸納總結(jié) WHO PQ獨(dú)特要求，方便制藥企業(yè)了解以便更好的滿足 WHO PQ 要求。 研究結(jié)果：注射用頭孢曲松處于 UNICEF 第 40 位優(yōu)先采購(gòu)清單，且目前只有 4家通過(guò) WHO PQ，非洲等地區(qū)也逐步上量，其市場(chǎng)前景良好。 中國(guó) 醫(yī)藥 “ 十二五 ”支持企業(yè) 加快 WHO 預(yù)認(rèn)證等 國(guó)際認(rèn)證， WHO 也鼓勵(lì) 企業(yè) 開(kāi)展 WHO PQ，可提供一系列 的 培訓(xùn)和指導(dǎo)。 中國(guó)化學(xué)仿制藥注冊(cè) 要求 和新版 GMP 認(rèn)證標(biāo)準(zhǔn)，均與 WHO PQ文件準(zhǔn)備和現(xiàn)場(chǎng)審計(jì) 內(nèi)容基本一致 ， 在此基礎(chǔ)上 企業(yè)通過(guò) WHO PQ 在技術(shù)方面是可行的。 且 WHO 與 PIC/S、 ICH 等國(guó)際組織合作緊密， WHO 預(yù)認(rèn)證要求符合國(guó)際標(biāo)準(zhǔn)，對(duì)企業(yè)提升國(guó)際質(zhì)量管理水平很有裨益。 研究結(jié)論：中國(guó)化學(xué)仿制藥生產(chǎn)企業(yè)在國(guó)內(nèi)注冊(cè) 和審計(jì)基礎(chǔ)上，同時(shí)關(guān)注 WHO PQ 的 產(chǎn)品文件 和現(xiàn)場(chǎng)審計(jì) 要求 ，既響應(yīng)了國(guó)家行業(yè)發(fā)展政策，也有巨大的市場(chǎng)潛力，通過(guò) WHO PQ 切實(shí)可行。 關(guān)鍵詞： WHO PQ；注射用頭孢曲松； 可行性； 國(guó)際采購(gòu) II The Feasibility Study of WHOＰ requalification for Chinese Chemical Generic Drug Manufacturers Case study: Ceftriaxone for Injection Background: WHO PQ is WHO’s prequalification programme for medicines and medicine manufacturers, which is the only global pharmaceutical qualification program. It aims to provide safe, effective and quality essential medicines to the patients in developing countries, especially the medicines needed for the serious worldwide diseases like AIDS, tuberculosis and malaria. Now WHO PQ list has bee the procurement guideline for international agencies, and also more and more countries refer to it for their procurement needs. China is a big pharmaceutical manufacturing nation, successful WHO PQ is the prerequisite for Chinese pharmaceutical enterprises to participate in the UN and other international procurement for medicines. Because it doesn’t require a brand new drug to participate in the programme, many chemical generic drug manufacturers can enter the international market through WHO PQ. Purpose: Take Ceftriaxone for Injection as an example to help Chinese chemical generic drug manufacturers better understand WHO PQ requirements better, and be approved by WHO PQ, finally participate in international procurement. Methods: Take Ceftriaxone for Injection as an example to investigate its potential market, collected and analyzed WHO PQ related policy and regulations, pared the Chinese chemical generic registration amp。 GMP standards with the WHO PQ requirements, and summarized special requirements of WHO PQ. Studies in the above three aspects provided better understanding of WHO PQ feasibility and requirements, and could help Chinese enterprises to get a successful WHO PQ. Results: The study showed Ceftriaxone for Injection ranks in top 40 in UNICEF procurement priority list, and currently there are only 4 products in WHO PQ list。 moreover, its market volume in Africa and other regions gradually increases. Chinese pharmaceutical Twelfth FiveYear Plan supports to speed up the pace of international certification, like WHO PQ. WHO also encourages enterprises to start WHO PQ by providing series of training and guidance to the manufacturers. Chinese generic drug registration requirements for chemical medicines and new Chinese GMP standards are basically the same as that for WHO PQ dossier and onsite audit, so the technical feasibility is proved. Therefore, Chinese enterprises should pay attention to WHO PQ III requirements on submission documents and onsite audit in order to be approved. WHO keeps close cooperation with PIC/S and ICH which push international standards in the world, WHO PQ requirements ply with international standards, so the enterprises will improve international quality management level through WHO PQ. Conclusion: Based on domestic registration and onsite inspection, Chinese chemical generic drug manufacturers to be approved by WHO PQ is feasible, which is inline with Chinese pharmaceutical industries’ overall growth strategy, and also will provide market advantage globally. Key words: WHO PQ, Ceftriaxone for Injection, Feasibility, International Procurement 目 錄 IV 第 1 章 緒 論 ..........................................................................................................................1 研究背景 ....................................................................................................................1 WHO 預(yù)認(rèn)證簡(jiǎn)介 ...............................................................................................1 WHO 預(yù)認(rèn)證發(fā)展概況 ........................................................................................2 中國(guó)化學(xué)仿制藥行業(yè)現(xiàn)狀 ..................................................................................4 研究目的與意義 .........................................................................................................5 第 2 章 研究設(shè)計(jì) .....................................................................................................................6 數(shù)據(jù)來(lái)源 ....................................................................................................................6 研究方法 ....................................................................................................................6 第 3 章 法 規(guī)政策可行性研究 ...................................................................................................6 中國(guó)法規(guī)政策研究 ......................................................................................................6 WHO PQ 政策分析 ......................................................................................................7 WHO 為企業(yè)提供免費(fèi)培訓(xùn)和指導(dǎo) ......................................................................7 WHO PQ 與其他國(guó)家藥監(jiān)局關(guān)于簡(jiǎn)化注冊(cè)的政策 ..........................................