聶黎行 戴忠 馬雙成
摘要國際植物藥監(jiān)管合作組織是由WHO與多國政府發(fā)起成立的國際性合作組織,致力于通過完善植物藥監(jiān)管規(guī)章,保護并促進公眾健康與安全。我國為該組織下屬第二工作組(WG2:Quality control of herbal materials and products(including reference standards)的主席國,針對植物藥對照物質開展合作和交流,以加強植物藥及其制劑的質量控制,保障用藥安全有效。本文對作者起草的WHO國際植物藥監(jiān)管合作組織(IRCH)第二工作組章程的英文全文加以介紹,以期為相關國際交流和合作工作提供參考。
關鍵詞國際植物藥監(jiān)管合作組織;植物藥;監(jiān)管;世界衛(wèi)生組織;章程;質量控制;對照物質;國際合作
中圖分類號:R283文獻標識碼:Adoi:10.3969/j.issn.1673-7202.2019.01.050
國際植物藥監(jiān)管合作組織(Introduction on International Regulatory Cooperation for Herbal Medicines,IRCH)成立于2006年,是由世界衛(wèi)生組織(WHO)基本藥物與傳統(tǒng)藥物技術合作司與多國政府發(fā)起成立的國際性合作組織,致力于通過完善植物藥監(jiān)管規(guī)章,保護并促進公眾健康與安全[12]。IRCH的成員為國家或地區(qū)的藥品監(jiān)督管理機構,目前包括阿根廷、亞美尼亞、澳大利亞、巴西、文萊、加拿大、智力、中國、中國香港特別行政區(qū)、古巴、加納、德國、匈牙利、印度、印度尼西亞、意大利、日本、馬來西亞、墨西哥、阿曼、巴基斯坦、秘魯、葡萄牙、韓國、沙特阿拉伯、新加坡、南非、阿聯(lián)酋、英國、坦桑尼亞、美國、東盟(Association of Southeast Asian Nations,ASEAN)、歐洲藥品管理局(European Medicines Agency,EMA)和拉丁美洲議會(Latin American Parliament,PARLATINO)[3]。2017年,該組織正式加入WHO的工作網絡,其國際規(guī)模及影響力正在逐步擴大。IRCH通過在植物藥安全、質量、有效方面的監(jiān)管經驗、信息和知識共享,形成國家/組織相關監(jiān)管和立法機構的共識,促進和加強成員間合作。具體工作通過下設的4個工作組(WG)開展,分別為:WG1:Identification of adulteration of products;WG2:Quality control of herbal materials and products(including reference standards);WG3:Evidence;WG4:Vigilance of herbal medicines。
中國是植物藥的生產和使用大國[4],中藥是全球植物藥的重要組成部分,中國是IRCH的第1批成員國,也是第2工作組(WG2)的主席國。在國家食品藥品監(jiān)督管理總局的領導下,中國食品藥品檢定研究院中藥民族藥檢定所(以下簡稱中檢院中藥所)具體承擔第2工作組的工作,現(xiàn)階段針對植物藥對照物質開展合作和交流,以加強植物藥及其制劑的質量控制,保障用藥安全有效。研究對象主要包括與植物藥相關的化學對照品、對照藥材和對照提取物,擬研究內容包括對照物質及標定技術指南、合作制備、協(xié)作標定、對照物質在質量控制中的應用、標定新技術、對照品替代法、對照物質譜庫和電子對照物質等[912]。2015年,筆者起草了第2工作組的章程(Terms of Reference),分別于2015年和2016年組織召開了小組會議進行討論,并廣泛征求所有IRCH成員的意見,最終于2017年在IRCH年會上通過。以國際植物藥監(jiān)管合作組織為舞臺,大力推進植物藥質量控制與標準物質研究等實質性的國際合作,樹立了我國在植物藥監(jiān)管領域的引領地位,并有利于中檢院中藥所世界衛(wèi)生組織傳統(tǒng)醫(yī)藥合作中心工作的順利開展。
隨著中醫(yī)藥現(xiàn)代化和國際化進程的加速[58],中國的監(jiān)管和研究人員在越來越多的國際組織中發(fā)揮著越來越重要的作用?,F(xiàn)對WHO國際植物藥監(jiān)管合作組織(IRCH)第2工作組章程的英文全文加以介紹,以期為相關國際交流和合作工作提供參考[914]。
Working Group 2:Quality Control of Herbal Materials and ProductsInternational Regulatory Cooperation for Herbal Medicines(IRCH)Terms of Reference
1.Aim of the group
The role of working group 2(WG2)is to share information and work collaboratively on issues related to quality control of herbal materials and products in order to:
·Construct scientific and technical platform for regulation,standards,reference standards and quality control methods of herbal materials and herbal products;
·Provide reference for consideration by IRCH and drug authorities of the members;
·Improve safety,quality and efficacy of herbal materials and products; and finally
·Protect and promote public health.
2.Membership
2.1Lead country
People′s Republic of China
2.2Contact information for WG Lead
MA Shuangcheng,Ph.D,Professor
Institute for Control of Chinese Traditional Medicine and Ethnic Medicine(ICCTMEM)
National Institutes for Food and Drug Control(NIFDC)
China Food and Drug Administration(CFDA)
No.2 Tiantan Xili,Dongcheng District,Beijing,P.R.China
Tel:00861067095272(office)
Fax:00861067095887(office)
Email:mashuangcheng@yahoo.com; masc@nifdc.org.cn
2.3Participating Members
·Argentina
·Brazil
·ChinaHong Kong SAR
·Cuba
·India
·Indonesia
·Malaysia
·Mexico
·Peru
·Saudi Arabia
·Tanzania
3.Accountability
Individual group members are responsible to report on activities and achievements of its own country to WG Lead as there is a collaborative activity or discussion of WG2.The lead country is responsible for reporting working progress of the group on annual meetings of IRCH.
4.Ways of working
4.1Group discussion
·Any group member is encouraged to propose topic or question for discussion;
·The scope of information exchange,requests and replies will be limited to issues related to quality control of herbal materials and products; and
·Group members are suggested to share information and resources by emails.
4.2Group meeting
·Group meeting may be held in flexible form at irregular intervals;
·The lead country is responsible to arrange and chair the meeting;
·Any group member is encouraged to organize the meetings; and
·Nonmembers are welcomed to take part in the group meeting as observer.
4.3Collaborative research
·Collaborative research may involve:
·regulation,standards,reference standards and quality control methods of herbal materials and herbal products.At current stage,more specific study can be focused on:
·General guideline of reference standards for herbal materials and herbal products,including chemical reference substances,reference herbal materials and reference extracts;
·Preparation,calibration and collaborative calibration of reference standards for herbal materials and herbal products;
·Atlas of reference standards for herbal materials and herbal products;
·Substitute methods of reference standards for herbal materials and herbal products;
·Digital reference standards for herbal materials and herbal products;
·New technologies and methods concerning calibration of herbal materials and herbal products; and
·Application of reference standards in quality control of herbal materials and products.
5.Review of these Terms of Reference
The Terms of Reference of WG2 will be reviewed and revised on an as needed basis.
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(2018-01-17收稿責任編輯:張文婷)