CFDA局长毕井泉：药品标准的极端重要！

日前，第十一届药典委员会成立大会暨第一次全体会议在京召开，国家食品药品监督管理总局局长、第十一届药典委员会主任委员毕井泉为新一届药典委员会委员代表颁发聘书，并发表讲话，建立中国药品橙皮书制度、现代医学理论方法研究的传统药归入现代药申报管理、破解药物制假“潜规则”、研究制定药品退市的标准、条件与程序等重大改革被明确公开。

第十一届药典委员会由405名委员组成，设执行委员会和26个专业委员会。毕井泉任第十一届药典委员会主任委员，国家食品药品监管总局副局长吴浈任常务副主任委员，中国工程院院士、中国中医科学院院长张伯礼，中国科学院院士、中科院上海药物研究所陈凯先，中国工程院院士、中国医学科学院院长曹雪涛任副主任委员。

以下为毕井泉局长在第十一届药典委员会成立大会上的讲话全文（中英文）

今天，我们在这里隆重举行第十一届药典委员会成立大会暨第一次全体会议。我代表食品药品监管总局对大会的召开表示热烈的祝贺！向全体委员，特别是新当选的委员表示诚挚的问候！

这次会议的主要任务是：部署2020年版《中国药典》编制工作，推进药品标准改革，加强药品标准全程管理，推动药品质量水平进一步提高。下面，我讲几点意见。

一、充分认识药品标准的极端重要性

药典是药品科学技术发展成果的结晶，是一个国家药品产业发展水平的标志，是药品生产经营者的基本遵循，是药品监管工作的准绳。

党的十八大以来，习近平总书记多次强调，要把“最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责”落到实处，确保人民群众饮食用药安全。习近平总书记把“最严谨的标准”放在首位，突显了标准对于药品监管工作的极端重要性。

习近平总书记还强调，“谁制定标准，谁就拥有话语权；谁掌握标准，谁就占据制高点”，深刻阐述了标准对于产品质量的决定性作用。李克强总理多次强调要下决心提高药品质量，严守从实验室到医院的每一道防线。

党中央、国务院十分重视药品标准工作。1949年，新中国刚刚成立，就组织专家研究编制新中国药典，把药品标准化建设作为改变我国医药产业基础薄弱、人民群众缺医少药落后局面的战略措施。1950年，中华人民共和国药典委员会成立，这是新中国最早的标准化组织。1953年，国家颁布第一版《中国药典》。

改革开放以后，药品管理法明确了药品标准的法定地位和药典委员会的法定职责，每五年编制一版药典，药品标准工作和《中国药典》制修订工作步入法治化轨道。

迄今为止，我国已经颁布实施十版药典，药品标准从无到有、收载品种从少到多、标准水平从低到高，对提高我国药品质量水平、促进医药产业转型升级发挥了重要作用。历届药典委员会功不可没。我们大力提高药品安全性标准，加强药品安全监管，近几年没有发生大的、影响恶劣的药害事件。这些都要充分肯定。

但是，我们也要看到，由于历史条件所限，产业发展起步较晚，政府监管能力较弱，药品标准还不能适应监管的需要，与人民群众的期待还有差距。药品质量疗效与美欧日国家有差距，很大程度上是药品上市标准不高，市场上缺乏原研产品作为参比对照。标准缺失、标准落后、标准不管用、标准执行不到位等问题也不同程度存在。

我们要认真贯彻落实习近平总书记关于药品监管工作的重要指示，加快标准制修订工作，建立科学、全面、可检验、能执行的标准体系，用“最严谨的标准”提高药品质量疗效，防范药品安全风险，为药品监管工作打下坚实的基础。

二、希望认真研究的几个问题

在新一届药典委员会成立、2020年版药典全面启动编制的时候，我想请药典委员会各位委员共同研究几个问题。这几个问题，对于制订标准、修订法律、推进改革、加强监管，都具有重要意义。

（一）研究药典工作的定位。药典编制工作要贯彻以人民为中心的发展思想，服务于药品监管工作，服务于改革创新，服务于制药产业的发展。编制药典的目的是鼓励好药、淘汰差药、识别劣药假药。

（二）研究现代药的本质特征和传统药的本质特征，以及现代药与传统药的区别。中华人民共和国宪法和药品管理法都提出了国家发展现代医药和传统医药的要求。要研究现代药与传统药的基本概念，明确界定其内涵和外延。

药的概念自古有之。各民族历史上都有自己的传统药。我国的中医药文化更是博大精深，在中华民族繁衍生息、与疾病作斗争方面发挥了重要作用。说我们曾经历过缺医少药的年代，主要指的是缺现代医药。

现代药伴随着现代医学传入中国。现代药是在传统药的基础上，结合现代循证医学，逐步完善形成了今天的基本特征：以医学、化学、生物学等理论为基础；一般都具有明确的活性成分，并不断研究完善其作用机理；经过随机双盲大样本的临床试验，通过试验数据证明对某种适应症有效，对病人个人或人类社会特定疾病的预防或治疗获益大于风险。所以药品审评要临床主导，由临床医生背景的审评员作审评组长。

此外，还有经过监管部门审批的制作方法和工艺，确保质量均一、稳定；对药品的全面监督，由药品上市许可持有人履行全生命周期的责任，开展上市后研究，监测不良反应，完善对药品的认识，包括药品说明书中载明的副作用、禁忌、注意事项等；对已上市药品不断评价、退出市场的规范制度。

传统药是传统的医学理论、传统的制备方法指导下，采取传统的剂型和使用方式、传统的适应症表述、传统的循证方法，有多年使用历史、公众认可的药品。传统的中医药理论是中华民族的文化瑰宝，我们必须发扬光大，继承发展。

现代药与传统药最重要的区别就是双盲随机大样本的临床试验证据，获益大于风险的适应症结论，产品均一、稳定的质量控制。如果用现代医学、现代药学理论，现代制备方法、现代循证方法研究传统药，其成果应按现代药申报、审评和监管。

这些年，我们在用现代药方法研究开发传统药方面，取得过重要成果。青蒿素、黄连素、麻黄素的发现，特别是青蒿素的发现，是我们对人类社会的重大贡献。用三氧化二砷治疗白血病作用的研究，也是举世瞩目的成果。

我们要认真总结这些年天然药物开发研究的经验教训，有哪些临床接受、国际公认的成果，又有哪些教训，走了哪些弯路，对我们继承发展传统药意义重大。

（三）研究新药上市标准、橙皮书和药典的关系。按照现代药品监管的理念和实践，批准上市一种创新药，就是批准一种药品的标准，包括活性成分、配方、用药途径、剂型、规格、使用方法、制作工艺及作为企业商业秘密的工艺参数。这些也是产品上市后的监管依据。

企业必须按照批准的标准生产，整个生产过程的数据都要做到真实、完整，及时记录，可以溯源，否则就要以掺假药品论处。

这种经监管部门审批上市的新药带有原创性、标杆性，其申请的专利受专利法保护。专利到期后，企业申报仿制药生产上市可以借用原研企业的成果和数据，免于重新做大样本临床试验，监管部门按原研药的标准审查其药学等效性和生物等效性，二者等效即视为疗效等效，可以在临床上相互替代。

上述经批准上市的作为参比制剂的原研药与经评价疗效等效的仿制药载入一个目录集，及时更新，这就是国际上的橙皮书制度。我们也要建立中国的橙皮书制度。我们要研究批准上市新药的标准、橙皮书和药典之间的关系，各自发挥什么作用。

编制修订药典，一定意义上是对已上市药品的再次审查和确认。药典编制过程中，要对收载、更新、修订的内容进行真实性、可靠性、科学性的审核，评估其安全性、有效性和质量可控性。真实性、可靠性、科学性存疑的，安全性、有效性、质量可控性存疑的，要向监管部门提出处理意见和建议；多年不生产的药品，要提出处理意见和建议；上市后多年没有进行不良反应监测、不良反应不详的药品也要提出处理意见和建议。委员们要在修订药典时严格把关，这是对公众负责，也是专家委员会的责任。

（四）在药典修订中体现改革成果，为改革创新服务。2015年以来，总局认真贯彻落实党中央、国务院决策部署，会同相关部门全面推进药品审评审批制度改革。改革已不限于审评审批，逐步拓展为药品监管制度的全面变革。

为什么要改革？一是药品可及性基本解决，但质量疗效上有差距。

二是药品研发、生产、经销生态出了问题。研发中数据不真实、不完整的现象；生产加工过程中擅自更改工艺、掺杂使假、偷工减料的现象，数据不完整、不真实、不可靠、不可溯源的现象；经销过程中夸大宣传、无科学依据地乱吹牛的现象，屡见不鲜，屡禁不止。

三是审评和监管力量薄弱。与制药产业的迅猛发展相比，我们的监管队伍人员严重缺乏，能力不足，难以实施有效监管，漏洞死角很多。对存在的问题认识到了，但解决起来困难重重，心有余力不足。

四是申请积压，效率低下。这是前三个问题交织的必然结果。

怎么改革？党中央、国务院已经作了一系列重大决策。

2015年8月国务院印发《关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号），2015年11月全国人大常委会批准在10个省市开展药品上市许可持有人制度试点，2016年2月国务院办公厅印发《关于开展仿制药质量和疗效一致性评价的意见》（国办发〔2016〕8号），2017年2月国务院印发《“十三五”国家药品安全规划》（国发〔2017〕12号），2017年7月中央全面深化改革领导小组审议通过了《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》。

经国务院批准，我们加入了国际人用药品注册技术协调会（ICH），下一步还要争取加入国际药品认证合作组织（PIC/S）。

改革总的目标就是与国际接轨。药品上市的基本标准就是新药要“全球新”，仿制药要与原研药质量疗效一致。要研究建立药品数据保护制度、专利补偿制度、药品审评与专利链接制度，把专利纠纷解决在药品上市之前，既鼓励药品创新，使创新者受到激励；也鼓励仿制，降低企业仿制成本和法律风险。

要建立临床主导的团队审评制度、与申请人会议沟通制度、项目管理员与申请人联系制度、专家咨询委员会公开论证重大争议制度、审评结论和依据向社会公开制度，保证审评的公平公正。要实现药品全生命周期管理，实现药品研发、加工、经销、使用全链条的监管。药品批准文件持有人要承担研发、加工、经销、不良反应监测、完善药品质量等全生命周期的法律责任。临床试验数据不真实、不完整、不可溯源的申请，一律予以退回。

生产加工过程违反GMP规范，数据不真实、不完整、不可溯源的，要严肃处理，并向社会公开处理结果。对造假等严重违法者，要依法追究刑事责任。要建立审评员、检查人员、检验人员、执法人员保守企业商业秘密制度，建立禁止工作人员私下透露药品审评信息制度。严禁工作人员以审评谋私、以检查谋私、以企业商业秘密谋私。通过保密责任的落实取信于民，保证监管权威。

改革既包括今后上市药品如何审评审批，也包括对以前批准上市药品的评价和清理。规定期限通不过评价的要退市。长期不生产的、自行改变工艺的、没有履行上市后研究和药物警戒责任的、安全性有效性质量稳定性存在问题的，要清理、纠正，性质严重的要退市。要研究制定药品退市的标准、条件与程序。

新一版药典编制，正处于改革关键时期，情况会有很多变化。药典编制工作要落实党中央、国务院关于药品审评审批、药品监管改革的一系列要求，体现改革的成果，及时反映药品质量疗效的提高。

希望新一届药典委员会的每一位委员都秉持严谨、科学、公正、客观的态度，积极参与改革，推动改革，服务改革。我们每一位制药业的从业人员、药学研究工作者、监管者，都是改革的参与者、推动者。符合广大人民群众利益的，有利于促进公众健康的事情，都要积极推动；不符合人民群众利益，不利于促进公众健康的事情，就要果断放弃。

我们所有的工作，都要经得起历史的检验。在改造客观世界的同时，也要改造我们的主观世界，学习新知识，掌握新技能，创新体制机制，加强能力建设。

（五）研究药典编制如何为破解掺假、造假的“潜规则”服务，为监管服务。当前有一种现象，药典中规定检验哪些指标，就有人研究如何骗过这些指标的掺假造假方法。请各位专家结合自己专长研究如何解决这个问题，及时堵住漏洞，破解“潜规则”。

三、提几点要求

药典委员会是我国药学领域最具权威性的技术机构，承担着党和国家赋予的制定国家药品标准的神圣使命。编制药典，是现代“悬壶济世”的功业。第十一届药典委员会今天正式成立了，各位作为国家的一名药典委员，不仅仅是响当当的荣誉，更是沉甸甸的责任。我们每一位药典委员都要把使命和责任铭刻在心，以高度负责的精神圆满完成药典编制工作。

第一，坚持科学态度。各位委员来自不同的领域和专业，要互相尊重，互相学习，取长补短，平等讨论。以科学严谨的作风、求真务实的态度、勇于创新的精神努力工作。

第二，勇于担当作为。每一个标准的修订都会遇到各种矛盾、困难和问题，任何一种选择都可能有不同意见。我们要以人民利益、公众健康为基本出发点，敢于直面问题，勇于担当作为，化解工作难题，做出“仰不愧于天，俯不怍于人”的工作业绩。

第三，加强制度建设。要修订标准工作规章制度，完善标准工作程序，建立利益冲突回避制度、公开论证重大分岐制度、公开回应未采纳的实质性意见制度，民主决策，科学决策，公开决策，接受社会监督。

第四，坚守清正廉洁的职业道德。制修订标准是履行国家的公权力。药典委员必须遵守国家公职人员的法律、纪律。

党员委员在履职过程中，还要遵守中央八项规定精神和党员的各项纪律，非党员委员也要按照中央八项规定精神严格要求自己，坚持原则，不为利益所惑，不为私情所动。如有违反国家法律和职业道德的行为，要从严查处并公开处理结果。

各位委员、同志们，药品标准工作责任重大、使命光荣。我们要更加紧密地团结在以习近平同志为核心的党中央周围，坚持以人民为中心的发展思想，认真落实“四个最严”要求，用更科学的标准保障药品质量，支撑药品监管，引领产业发展，以优异的经得住历史检验的工作成果，为中华民族健康事业作出新的贡献。

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附英文版：

Today, we are here to hold the founding conference of the11^th Chinese Pharmacopoeia Commission and its first plenarysession. On behalf of the China Food and Drug Administration, I would like toconvey my congratulations for this conference and extend my sincere greetingsto all the commission members, especially the members newly elected!

The main tasks of thisconference are to: to arrange the compilation work of the 2020 edition Chinese Pharmacopoeia, to promote the drugstandard reform, to strengthen the whole process administration of the drugstandard and to further improve the quality of drugs. Here are someobservations.

I. Fully recognizing thevital importance of the drug standard

The pharmacopoeia is the quintessence of thescientific and technological development achievements of drugs, the symbol forthe development level of the drug industry of a country, the basic standard forthe pharmaceutical manufacturers and distributors and the criterion for thedrug administration work. 

Since the 18th CPC National Congress, XiJinping, the General Secretary of the CPC Central Committee, has emphasized formany times that “the most stringent standard, the most rigorous administration,the most severe punishment and the most serious accountability system” shouldbe put into practice to ensure the food and drug safety of the people. GeneralSecretary Xi Jinping puts “the most stringent standard” at the first place, andit highlights that the standard is of significant importance for the drugadministration work. He also stresses, “The one who establishes the standardwill have the voice; the one who grasps the standard will occupy the commandingheight”. It deeply elaborates that the standard plays a decisive role for theproduct quality. Premier Li Keqiang also emphasizes that we should bedetermined to improve the drug quality and strictly observe each defensive linefrom the lab to the hospital.

The CPC Central Committee and the State Councilattach great importance to the drug standard work. In 1949, when the People’sRepublic of China was just established, the experts were organized to compilethe new Chinese pharmacopoeia and the drug standardization was regarded as astrategic measure to change the backward situation of the weak pharmaceuticalindustrial basis and the few doctors and little medicine for the masses. In1950, the Pharmacopoeia Commission of the People’s Republic of China was setup, and it became the first standardization organization of the New China. In1953, the first edition Chinese Pharmacopoeia was issued.

After the reform and opening-up policy wasimplemented, the legal status of the drug standard and the legalresponsibilities of the Chinese Pharmacopoeia Commission are clearly defined inthe Drug Administration Law. The Chinese Pharmacopoeia should berecompiled every five years. The drug standard work and the compilation andmodification of the Chinese Pharmacopoeia are legalized.

Thus far, China has issued ten editionsof Chinese Pharmacopoeia. The drug standard develops from nothing, fromfew types to many types, from low level to high level. They play importantroles in improving the drug quality level of our country and promoting thetransformation and upgrading of the pharmaceutical industry. The previousPharmacopoeia Commissions made great contributions. We have greatly raised thedrug safety standard, strengthened the drug safety administration, and no majoror serious drug incidents have taken place in recent years. All of these shouldbe affirmed fully. 

However, we also have to notice the backwardindustrial development, the poor regulatory capacity of the government, thefailure of the drug standard to meet the requirements of the administration andthe gap with the expectations of the masses due to the limited historicalconditions. There are gaps between the drugs’ quality and efficacy of ourcountry and those of the America, European countries and Japan, largely becausethe drugs are of low listing standard and there are insufficient branded drugin the market for reference. Such problems as the shortage, backwardness,unavailability, insufficient performance of the standard also exist to someextent. 

We should conscientiously carry out GeneralSecretary Xi Jinping’s instructions on the drug administration work, speed upthe standard formulation and modification, set up the scientific, complete,verifiable and executable standard system and improve the quality and efficacyof drugs with “the most precise standard” to prevent the drug safety risks andlay solid foundation for the drug administration work.

II. Some Issues Needed to beStudied Carefully

As the new Pharmacopoeia Commission has beenset up, and the compilation of the 2020 edition pharmacopoeia has been launchedcompletely, I would like to ask each member to study some issues together.These issues are of great importance for the standard formulation, the lawrevision, the promotion of reform and the administration enhancement.

(I) Studying the positioning of thepharmacopoeia work. The compilation of the pharmacopoeia should be carried outby implementing the development thought of being centered on the people,serving the drug administration, serving the reform and innovation and servingthe development of the pharmaceutical industry. The purpose of compiling thepharmacopoeia to promote the high-quality drugs, eliminate the poor-qualitydrugs and identify the substandard and counterfeit drugs.

(II) Studying the essence of the modern drugsand the traditional drugs as well as their differences. The requirement thatthe state should develop the modern medicine and the traditional medicine isstated both in the Constitution of the People’s Republic of China and in theDrug Administration Law. The basic concepts of the modern drugs and thetraditional drugs should be studied to clearly heir connotation and extension.

The concept of drugs came into being in ancienttimes. Every nation has its own traditional drugs historically. The traditionalChinese medicine culture of our country is extensive and profound and hasplayed an important role in the lives of the Chinese nation and its strugglingagainst diseases. The said age that we have ever lacked of doctors andmedicines mainly refers to the age that we were short of modern doctors andmedicines.

The modern drugs came to China with the modernmedical science. The modern drugs gradually have the current basiccharacteristics on the basis of the traditional drugs and in combination withthe modern evidence-based medicine: based on the theories of medical science,chemistry, biology and the like; generally having defined active ingredientsand continuously studying and perfecting its functioning mechanism; goingthrough the random and double blind clinical trial with large-scale samples,being proved effective on some indications by the test data, with benefits forthe prevention or treatment of the certain disease of an individual patient orthe human society larger than the risks. So the drug evaluation should be ledby the clinical trials with the reviewer with the clinical doctor background asreview team leader. 

In addition, there should be the productionmethods and processes approved by the regulatory authority to guarantee theuniform and consistent quality; for the overall supervision of the drugs, themarketing authorization holder should be responsible for the whole life circleof drugs, implement post-marketing studies, monitor adverse drug reactions andimprove the understanding of drugs, including the side effects,contraindications, announcements and so on stated in the package insert;standardizing the continuously evaluating and market withdrawing system of themarket drugs.

The traditional drugs, used for many years andaccepted by the public, are the drugs adopting the traditional dosage form andusage, traditional indication expression, traditional evidence-based methodsunder the guidance of the traditional medicine theory and the traditionalpreparation methods. The traditional Chinese medicine theory is the culturaltreasure of the Chinese nation, and we must carry forward, inherit and developit. 

The most important distinction between themodern drugs and the traditional drugs lies in the evidence of thedouble-blinded random clinical trials with large-scale samples, indicationconclusions with more benefits than risks, as well as uniform and stablequality control of products. 

In recent years, we have made greatachievements in studying and developing the traditional drugs in the way forthe modern drugs, and some important achievements have been made. The discoveryof the artemisinin, berberine and ephedrine, especially the discovery of theartemisinin, constitutes our great contribution to the human community. We havealso achieved remarkable fruits in treating leukemia with arsenic trioxide,which is a result drawing the global attention. 

We should carefully summarize our experienceand lessons in the development and study of the natural drugs, including theoutcomes acceptable clinically and recognized internationally and the lessonsand faults. All of them are of significance for our inheriting and developingthe traditional drugs. 

(III) Studying the relation between new drugmarketing standard, the orange book and the pharmacopoeia. According to theregulatory concept and practices of modern drugs, approving a kind ofinnovative drug is approving the standard for such drug, including the activeingredients, formula, the administration route, the dosage form, thespecifications, the usage, the technique and the technological parameters asthe business secret of an enterprise. All of these are also the criteria forpost-market regulation of products. 

Enterprises must manufacture drugs inaccordance with the approved standards, and the data of the whole productionprocess should be authentic and complete, recorded in time and traceable.Otherwise, punishment will be made for adulterated drugs. 

The new drugs approved by the regulatoryauthority characterize the originality and the standard, and the patentsapplied for them are protected by the patent law. After the patent expires, theenterprises applying for the generic drugs can make use of the reference listeddrug enterprises’ results and data, and the clinical trial with large-scalesamples can be avoided. The regulatory authority reviews their pharmaceuticalequivalence and biological equivalence in accordance with the standard of thereference branded drug, and if both of them are equivalent, the efficacy willbe deemed equivalent and they can replace each other clinically. 

The above reference branded drug approved to bemarketed and regarded as the reference product and the generic drugs evaluatedfor its efficacy equivalence are included in a directory set. The set isupgraded in a timely manner, and makes up the orange book systeminternationally. We also should establish the Chinese orange book system. Weshould study the relation between the new drug marketing standard, the orangebook and the pharmacopoeia and their roles.

To some extent, the compilation and revision ofpharmacopoeia are review and verification for marketed drugs. Review aboutauthenticity, reliability, scientificity shall be made for recording, renewaland revision of the contents to assess safety, effectiveness and qualitycontrollability. In case of doubt about authenticity, reliability,scientificity, safety, effectiveness and quality controllability, drugs thathave not been produced for many years, drugs without adverse effect inspectionfor many years after coming into the market, handling suggestion and adviceshall be proposed to the supervision department. Committee members shallmaintain strict standards in revising pharmacopoeia, because it is theresponsibility to the public and to the committee of experts.

(IV) Reform results shall be embodied inrevising pharmacopoeia to serve reform and innovation. Decisions andarrangements of the Party Central Committee and the State Council have beenfully implemented by China Food and Drug Administration to carry forwardreforms on assessment and approval of drugs in cooperation with relevantdepartments since 2015. Not limited to assessment and approval, the reformshave been developed into comprehensive reforms on supervision system of drugs.

Why should we carry out the reform? First,although drug accessibility has been basically solved, gap still exists inquality and efficacy. 

Second, there are problems in development,production and distribution of drugs. Untrue and incomplete data indevelopment, unauthorized changes in techniques, adulteration, jerry-buildingand incomplete, untrue, unreliable and untraceable data in production process,exaggerated advertisement and brag without scientific basis in distributionprocess have frequently emerged despite repeated prohibition. 

Third, assessment and supervision capacitiesare weak. Compared with rapid development of pharmaceutical industry, we areseriously short of supervisors. Due to scarce capacity, it is hard to exerciseeffective supervision, which causes many loopholes and blind space. Althoughexisting problems have been found, the solutions are beset with difficulties.So it is unable to do what we hope to do. 

Fourth, the application has been overstockeddue to low efficiency. This is an inevitable result because of the above threeproblems.

How should the reform be exercised? A series ofimportant decisions have been made by the Party Central Committee and the StateCouncil. Opinions on Reforming Review and Approval System of Drugs andMedical Devices (GF [2015] No. 44) was published by the State Council inAugust 2015. Piloting drug marketing authorization holder system was approvedby Standing Committee of the National People’s Congress in 10 provinces andmunicipalities in November 2015. Opinions on Consistency Assessment for Qualityand Efficacy of Generic Drugs (GBF [2016] No. 8) was published by GeneralOffice of the State Council in February 2016. National Drug Safety Planning inthe 13th Five Plan (GF [2017] No. 12) was published by the State Councilin February 2017. Opinions on Deepening Reforms of Assessment and ApprovalSystem to Encourage Innovation in Drugs and Medical Apparatus was deliberatedand approved by the Central Leading Group for Comprehensively Deepening Reformsin July 2017. 

With approval of the State Council, we joinedInternational Conference on Harmonization (ICH). Then we will strive to joinPharmaceutical Inspection Convention and Pharmaceutical Inspection CooperationScheme (PIC/S).

The overall goal of reforms is to be geared tointernational standards. The basic standard for new drugs to be marketed is tobe global new and generic drugs shall have the same quality and efficacy withoriginal drugs. Drug data protection system, patent compensation system anddrug review and patent linkage system shall be established with solution ofpatent disputes prior to drug marketing. Both drug innovation and innovatorsshall be encouraged and imitation shall also be encouraged to reduce imitationcost and legal risks of enterprises.

Team assessment system, conferencecommunication system with applicants, liaison system between project managersand applicants, expert consultation committee publicly demonstrating majordisputes system, assessment results and bases disclosure system shall beestablished with clinic as leading to guarantee justice and equity of theassessment. Drug life cycle management shall be achieved to realize supervisionin development, processing, distribution and utilization. Holders of drugapproval documents shall take the legal liability for drug life cycle,including development, processing, distribution, adverse effect supervision anddrug quality perfection. Application with untrue, incomplete or untraceableclinical trial data shall be revoked. 

Serious treatment shall be made for productionprocess violating GMP and untrue, incomplete or untraceable data with treatmentresults disclosed to the public. Criminal responsibility shall be lawfullyinvestigated for law breakers such as those counterfeiting. The system forreviewer, inspector, tester and law enforcement officer to keep businesssecrets of enterprises shall be established and the system for prohibitingstaff from disclosing drug assessment information privately shall also beestablished. Staff shall be prohibited strictly from seeking personal gainsfrom assessment, inspection and business secrets of enterprises. The authorityof supervision shall be guaranteed with implementation of responsibility forsecrets winning the trust of the people.

Reforms include assessment and approval fordrugs to be marketed in the future as well as evaluation and clearing for drugsmarketed in the past. Drugs fail in passing the evaluation within the specifiedperiod shall be withdrawn from the market. Long-term production halt, changingtechniques randomly, defaulting duty of research and vigilance after marketingof drugs, problems in safety, efficacy and quality stability shall be clearedand corrected and those serious shall be withdrawn from the market. Standards,criteria and procedures for withdrawal of drugs from the market shall beformulated.

In a critical period of reforms, changes mayoccur to the compilation of the new pharmacopoeia. A series of requirements ofthe Party Central Committee and the State Council about assessment, approvaland supervision reforms of drugs shall be implemented in the compilation of thepharmacopoeia to embody achievements of the reforms and reflect improvement inquality and efficacy of drugs promptly. 

I hope that members of the new PharmacopoeiaCommissionhold precise, scientific, impartial and objective attitude toparticipate in reforms actively, promote reforms and serve reforms. Allemployees, research workers and supervisors of the pharmaceutical industry areparticipants and impellers of the reforms. We shall actively promote mattersconforming to interests of the masses and facilitating health of the public.While we shall decisively abandon matters not conforming to interests of themasses or not facilitating health of the public. 

All the work made by us shall be amenable tothe history. While transforming the objective world, we shall also transformour subjective world to study new knowledge, master new skills, innovate systemand mechanism, reinforce ability construction.

(V) It shall be studied how to break the latentrules of adulteration and counterfeit and serve the supervision in thecompilation of the pharmacopoeia. Now it has been a kind of phenomenon thatpeople will study to find methods of adulteration and counterfeit for cheatingindexes specified in the pharmacopoeia. I hope that experts may find solutionsto this issue based on your specialties to prohibit loopholes and break thelatent rules.

III Some Requirements

Pharmacopoeia Commission is the mostauthoritative technical institution in pharmaceutical field of China and ittakes the sacred mission vested by the party and the country to formulatenational standards for drugs. The compilation of the pharmacopoeia is a task tohelp the patients. The 11th Pharmacopoeia Commission is officially establishedtoday. And it is a great honor and also a heavy responsibility to be members ofthe pharmacopoeia committee. All the members shall keep the mission andresponsibility in your heart to successfully complete compilation of thepharmacopoeia with high responsibility.

First, adhere to scientific attitude. Comingfrom different fields and specialties, members shall respect each other andlearn from each other with equal discussion. Precise style, pragmatic attitudeand innovative spirit shall be put in the work.

Second, take responsibilities bravely. Variouscontradiction, difficulty and problem may appear in the revision of allstandards and a choice may face different opinions. With people’s interests andhealth of the public as basic starting point, we shall dare to face problemsdirectly and take responsibilities in order to solve problems. Then workachievements may be made by us without shame and guilt.

Third, reinforce system construction. Rules andregulations for standards shall be revised and standard work procedures shallbe perfected. Besides, avoidance system for interest conflict, publicdemonstration system for major divergencies, public response system forsubstantial opinions not accepted shall be established to for democratic,scientific and public decision-making and social supervision.

Fourth, stick to disinterested professionalethics. It is the implementation of national public power to formulate andrevise standards. 

Members of the pharmacopoeia committee mustfollow the laws and disciplines for national public servants. Party members ofcommittee shall follow the spirit of eight-point rules and disciplines for themduring practice of work. Others shall also follow the spirit of eight-pointrules to stick to principles without malconduct for interests or personalrelationship. Behaviors violating national laws and professional ethics shallbe investigated and treated strictly with treatment results disclosed to thepublic.

All members and comrades, it is of greatresponsibility and glorious mission in making standards for drugs. We shallclosely unify to the Party Central Committee with Chairman Xi as the core toadhere to people-oriented development and exercise the requirements of the FourMost Strict. With more scientific standards guaranteeing drug quality,supporting drug supervision and leading industry development, new contributionwill be made to Chinese health industry by excellent working achievementsamenable to the history.