药用辅料药典标准规划及工作进展 chinese pharmacopoeia …

药用辅料药典标准规划及工作进展Chinese Pharmacopoeia Pharmaceutical excipients

standard planning and work progress

国家药典委员会

Chinese Pharmacopoeia Commission

洪小栩 Hong Xiaoxu

中美药用辅料标准论坛2017年11月18日北京

1

主要内容Main

content

工作规划Work plan

工作进展

Progress

面临

挑战Challenges

工作展望Work

prospects

2

适度增加品种的收载，进一步满足临床需要

Moderately increase the number of articles to be collected, fulfill clinical needs

坚持“临床常用、疗效确切、使用安全、工艺成熟、质量可控”的品种遴选原则

Adhere to the selection principle “common in clinical use, confirmed therapeutic effect, safe to use, mature production technology,

controllable quality"

全面覆盖国家基本药物目录、国家基本医疗保险用药目录，适应临床治疗用药指南调整变化的需要；

Comprehensively cover National Essential Medicines Directory, National Basic Medical Insurance Drug Directory, be adapted to changes

in the Clinical Medication Guidance

重点增加原料药、中药材、药用辅料标准的收载；新制剂的收载，要充分体现我国医药创新成果。

Emphasis will be placed on collection of APIs, TCM and pharmaceutical excipients. The collection of new final drug products should

fully reflect the achievements of China's pharmaceutical innovation.

《中国药典》2020版收载品种总数计划达到6400个左右，其中：中药增加品种约220个，化学药增加品种约420个，生物制品增加品种收载30个，药用辅料

增加品种约100个，药包材品种收载？？个，共约800个。药典已收载品种计划修订1300个，其中：中药500个，化药600个，生物制品150个，药用辅料150

个。

The total number of articles in "Chinese Pharmacopoeia" 2020 edition is planned to reach about 6400, among the new articles, about 220 are traditional

Chinese medicines, about 420 are chemical medicines, about 30 are biological products, and about 100 are pharmaceutical excipients. Packaging will

be ?? Totally about 800 new articles. There are 1,300 articles are planed to be revised, of which 500 are traditional Chinese medicines, 600 are

chemical medicines, 150 are biological products and 150 are pharmaceutical excipients.

《中国药典》2020年版编制框架Framework of 2020 edition ChP

-任务目标 Overall objectives

4

规范《中国药典》标准结构

Normalize Chinese Pharmacopoeia structure

进一步完善药典标准各部间的统一协调及内容规范。

Harmonize the standards between various categories

建立统一规范的药品通用名称命名规范（包括化药、中药、生物制品、药用辅料以及药包材）

Establishing unified naming conventions (including chemical medicines, traditional Chinese medicines, biological products,

pharmaceutical excipients and packaging materials)

研究制定药品标准编码体系，制定药典名词术语目录，规范药典用语

Developing drug coding system, pharmacopoeia terminology directory, normalize pharmacopoeial terms

完善《中国药典》标准体系

Improve "Chinese Pharmacopoeia" standard system

建立和健全横向涵盖中药、化学药、生物制品、原料药、药用辅料、药包材以及标准物质的药品标准体系。

To establish and perfect a standard system, covering horizontally the traditional Chinese medicines, chemical medicines,

biological products, APIs, pharmaceutical excipients, packaging materials and reference standards.

构建并完善纵向覆盖药典凡例、通则（检测方法通则、制剂通则）、总论以及涉及药品研发、生产、保存、运输等多环节全过程系列指导原则的

技术要求框架体系。

To establish and perfect a standard system, covering longitudinally General notices, General chapters (Methods of

Testing, Preparations), and technical requirements related to the whole process of drug R & D, production,

storage, transportation and other processes

《中国药典》2020年版编制框架Framework of 2020 edition ChP

-任务目标Overall objectives

6

国家药用辅料药包材标准National pharmaceutical excipients, packaging material standards

-国家药品安全十三五规划 National Drug Safety 13th Five-Year Plan

• 探索建立以关键质量风险控制为核心，以备案管理为手段的药用辅料、药包材与药品关联审评审批制度体系。

Establishing an approval system, that takes key quality risk control as the core, and pharmaceutical excipient/packaging

material filing management as means

• 进一步明确药品生产企业主体责任，监督履行对供应商的审计职责。

Further clarify the responsibilities of the pharmaceutical manufacturing enterprises, and fulfill audit responsibilities for

suppliers.

• 开展对药用辅料和药包材生产企业的延伸监管。

To carry out the expanded supervision of pharmaceutical excipients and packaging materials manufacturers.

• 根据风险程度，对药用辅料和药包材实行分类管理，加强风险控制

Classification of pharmaceutical excipients and packaging materials based on the degree of risk, strengthen risk control

• 健全标准体系 Improve the standard system

加强药用辅料和药包材监管Strengthen the supervision of pharmaceutical excipients and drug packaging

materials

完成3050个国家药品标准的制修订，包括中药和民族药标准1100个，化药标准1500个，生物制品标准150个，药用辅料标准200个，药包材

标准100个。

Complete the revision of 3,050 national pharmaceutical standards, including 1,100 standards for TCM and ethnic medicines,

1,500 for chemical medicines, 150 for biological products, 200 for pharmaceutical excipients and 100 for packaging

materials

2016-2018药品审评审批制度综合改革标准提高立项2016-2018 Drug review and approval system comprehensive reform to improve the

standards

为保障总局即将实施的药用辅料和药包材关联审批制度，进一步加强药用辅料和

药包材药典标准体系的建立和完善，加强药用辅料和药包材药典标准的制定工作•建立健全药用辅料标准体系

Establish and improve the standard system of pharmaceutical excipients

•全面规范药用辅料药包材的源头、过程控制要求

Regulate of the source, process control requirements of excipients and packaging materials,

•加强辅料安全性控制要求

Strengthen the safety control requirements of excipients

•生产、包装、贮藏、运输管理规范要求

Production, packaging, storage, transport management practices and requirements

•供应商审计以及安全评价等技术指南

Supplier Audit and Safety Assessment and other technical guidelines

•按照总局的工作部署，研究建立药用辅料DMF备案数据库的信息化平台

In accordance with the deployment of CFDA, establishment of pharmaceutical excipients DMF database

《中国药典》2020年版药典编制大纲要求Chinese Pharmacopoeia 2020 edition Pharmacopoeia compiling requirements

药用辅料和药包材 Pharmaceutical excipients and packaging

materials

• 建立和完善药用辅料和药包材标准体系

Establish and improve the standard system of pharmaceutical excipients and packaging materials

• 加强通用性要求和指导原则的制定，为药品与药用辅料、药包材关联审评审批制度改革提供强有力技术保障工作

To strengthen the general requirements, provide a strong technical foundation for the reform of the approval system

for pharmaceuticals, pharmaceutical excipients and packaging materials

• 增加常用药用辅料和关键药包材标准的收载，推进药用辅料和药包材品种的更新升级。

Increase the standard collection for commonly used pharmaceutical excipients and packaging materials, promote the

upgrading of excipients and packaging materials

• 进一步加强对药用辅料和药包材安全性的控制，并与国际相关要求保持一致

To further strengthen the control of the safety of pharmaceutical excipients and packaging materials, and be

consistent with international requirements

《中国药典》2020年版药典编制大纲要求Chinese Pharmacopoeia 2020 edition Pharmacopoeia compiling requirements

• 加强药包材标准体系的建立，在建立整体规范要求的基础上，针对不同种类的药包材，如玻璃类、橡胶类、塑料类等药包材分别建立相

应通用性技术要求

Establishment of the standard system for packaging materials, on the basis of the overall regulatory requirements,

establish the general technical requirements for various types of packaging materials, such as glass, rubber and

plastic

• 开展药包材安全性评价方法的建立和指南的制定，包括提取物、浸出物和毒性评价等安全性评价方法。

Development of safety assessment method and guidelines for packaging materials, including safety evaluation methods

for extractable, leachable and toxicity assessment.

• 建立并完善原料药、药用辅料、药包材相容性评价要求和技术指南的建立。

Establish and improve the API, pharmaceutical excipients, packaging materials compatibility requirements and technical

guidelines.

• 制定药用辅料、药包材生产管理规范，供应商审计要求以及药用辅料、药包材稳定性评估指南

Development of pharmaceutical excipients, packaging material production management practices, supplier audit

requirements and pharmaceutical excipients, drug packaging materials stability assessment guidelines

药用辅料药包材国家标准工作重点National standards focus on pharmaceutical excipients and packaging materials

药典标准体系 Pharmacopoeia standards system

通用性技术要求 General technical requirements

检验项目的设立 Establishment of testing items

检测方法的完善 Improvement of testing methods

标准体例的规范 Normalization of standards style

主要内容Main

content


工作进展

Progress

面临

挑战Challenges

工作展望Work

prospects

12

2009-2017药品标准课题任务2009-2017 Drug Standard Tasks

13

药用辅料药包材标准科研工作

Pharmaceutical excipients and packaging material research projects

-药品标准提高工作任务 Drug standard improvement tasks

类别Category

2009 2010 2011 2013 2014 2015 2016 2017 总计Total

方法学Methodology

4 / 12 55 18 11 16 24 140

药用辅料Excipients

50 25 25 240 174 13 9 3 549

药包材Packaging materials

50 / / 33 14 10 25 1 133

2016年度药品标准研究课题2016 Drug standards research project

编号课题项目 project 承担单位 Institute

5-3

药用辅料生物安全性评价方法指导原则 Guidance on

Biosafety Evaluation for

Pharmaceutical Excipients

北京市药品检验所 - 中国药科大学、深圳市药品检验研究院

5-4药用辅料适用性研究指导原则Guidance for the Applicability

of Pharmaceutical Excipients

中国药科大学上海市食品药品包装材料测试所

中国食品药品检定研究院、安徽山河药用辅料股份有限公司

5-5胶囊（空心胶囊）通则Capsules (empty capsules)

General chapter

中国医药包装协会中国药科大学中国食品药品检定研究院

6-1药包材稳定性评价指导原则Guidance on the evaluation of

packaging material stability

山东省医疗器械产品质量检验中心

中国医药包装协会中国食品药品检定研究院、山东齐都药业有限公司

6-2药用玻璃材料和容器通则Medical glass and containers

General chapter

中国食品药品检定研究院上海市食品药品包装材料测试所；

国家食品药品监督管理局药品包装材料科研检验中心

江苏省医疗器械检验所

6-3药包材胶塞通则Packaging material rubber

stopper General chapter

上海市食品药品包装材料测试所

中国食品药品检定研究院包装材料与药用辅料检定所 -

6-4

吸入气雾剂与包装相容性研究Compatibility of Inhalation

Aerosols and Packaging

material

中国医药包装协会山东省医疗器械产品质量检测中心（CFDA济南药品包装材料检验中心）；中国药典∣沃特世联合开放实验室

武汉药品医疗器械检验所、中国食品药品检定研究院

7-1制药用水Pharmaceutical water

中国医药设备工程协会中国食品药品检定研究院 -

2017年度药品标准研究课题2017 Drug standards research project

• 动物来源药用辅料生产和质量控制通则

General chapter for manufacture and quality control of animal-derived pharmaceutical excipients

• 预混/共处理辅料生产和质控技术指导原则

Pre-mixed/co-processing excipients production and quality control technical guidance

• 药用橡胶材料通则

General chapter for pharmaceutical rubber

• 药用塑料材料和容器通则

General chapter for pharmaceutical plastics and containers

• 预灌封注射器通则

General chapter for prefilled syringes

• 药用复合膜、袋通则

General chapter for pharmaceutical composite film, bag

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药用辅料适用性Applicability of pharmaceutical excipients

药用辅料功能性 Performance of pharmaceutical excipients

药用辅料相容性 Compatibility of pharmaceutical excipients

• 物理相容性 Physical compatibility

• 化学相容性 Chemical compatibility

• 生理学和和药学相容性 Physiological and pharmacological compatibility

药用辅料安全性 Safety of pharmaceutical excipients

– 改变使用途径和使用剂量 Change the route of administration and intake

- 新辅料：以前未使用过或尚未批准在知己是用过的辅料 New excipient: not used previously or not approved

（按照药用辅料安全性评价指南的要求，包括基本毒理资料）(In accordance with the requirements of the safety evaluation

guidelines for pharmaceutical excipients, including basic toxicological information)

药用辅料稳定性 Stability of pharmaceutical excipients

• 影响药品的稳定性或可制造性

Affect the stability or manufacturability of the drug

• 辅料对API生物利用度的影响

Affect API Bioavailability

• 可能产生有害的化学反应

May cause harmful chemical reaction

• API与辅料之间的相互反应以至于不能维持API的完整性

Interaction between API and excipients could affect API integrity

• 物理变化可能影响制剂成型

Physical changes can affect the formulation

• 对最终制剂性能的影响

Affect final drug product performance

• 干扰制剂中原料药的检测

Interference of detecting API in final drug product

药用辅料相容性Compatibility of pharmaceutical excipients

胶囊用明胶Gelatin for capsules

《中国药典》2015年版二部、四部 ChP 2015 edition, Vol. 2, Vol. 4

•动物的皮、骨、腱与韧带中胶原蛋白不完全酸水解、碱水解或酶降解后纯化得到的制品 Animal skin, bone, tendon and ligament collagen partial hydrolyzed by acid, alkaline or enzyme, and purified

《空心胶囊通则》（起草稿）General chapter for empty capsules

•明胶应来源于健康动物（猪、牛等）的皮、（猪、牛）骨中胶原蛋白不完全酸水解、碱水解或酶降解后纯化得到的制品，其中主要来源于新鲜牛骨、猪皮、牛皮，少数来源于猪骨等；Gelatin should be derived from the skin of healthy animals (pigs, cows, etc.), the products obtained by incomplete acid, alkaline or enzymatic hydrolysis of collagen;

•原料供应商都应有相应机构出具的检疫合格证书，并应有相应记录，做到来源可追溯，牛源性材料应来源于无疯牛病疫情地区的动物。Raw material suppliers should have the quarantine certificate issued by the corresponding agencies, and should have the corresponding records, so that the source can be traced back, bovine derived material should be derived from animals without BSEoutbreak

•EP 9.0

•明胶为来源于动物皮或骨胶原水解获得的凝固状或非凝固状的天然、可溶解蛋白Gelatin is a naturally-occurring, non-coagulated natural, soluble protein obtained from the hydrolysis of animal skin or collagen

•采用动物骨的：Animal Bones

– 应任何年龄＼任何国家来源的牛骨收集原料中，应将颅骨和脊柱骨去除 The skull and spine bone should be removed from any bovine bone collection of any age or origin of any country

– 超过３０月龄的牛来源的椎骨应去除 Bovine-derived vertebra more than 30 months of age should be removed

– 用于肠胃的医用胶囊生产用的牛股应来源于无BSE或风险可控地区 Bovine-derived for the production of gastrointestinal medical

capsules should come from BSE-free or risk-controlled areas

19

空心胶囊通则General chapter for empty capsules

• 原料来源（动物来源/非动物来源）Source of raw materials (animal origin / non-animal origin)

• 原料控制 Control of raw materials

• 配方成分 Formulation ingredients

• 制备工艺 Preparation process

• 生产环境 Production environment

• 基本控制项目 Basic control items

• 适用性 Applicability

• 稳定性 Stability

• 相关问题 Others

– 色素、油墨、批、批量、灭菌方法的、灭菌剂残留。。。Pigment, ink, batch, batch size, sterilization methods, sterilization agent residues.

20

我国对动物来源材料的控制法规要求China's laws and regulations on the control of animal-

derived materials

• 2015年《中国药典》2015年版、凡例、细胞规程 ChP 2015, general notices, cellular procedures

• 2008年9月生物组织提取制品和真核细胞表达制品的病毒安全性评价技术审评一般原则 General

Principles of Technical Review of Virus Safety Evaluation of Biological Tissue Extracts and

Eukaryotic Expression Products

• 2008年预防用以病毒为载体的活疫苗制剂的技术指导原则 Technical guidelines for the prevention

vaccine of virus-based live formulations

• 2008年疫苗生产用细胞基质的技术审评一般原则 General Principles of Technical Review of Cell

Substrates for Vaccine Production

• 2008年血液制品去除／灭活病毒技术方法及验证指导原则 Guidance for blood product virus

removal/inactivation techniques and validation

• 2002年7月10日关于进一步加强牛源性及其相关药品监督管理的公告国药监注[2002]238号 Announcement

on further strengthening the supervision of bovine origin and related drugs [2002] No. 238

• 2003年03月20日细胞培养用牛血清生产和质量控制技术指导原则 Guidance for Bovine Serum Production and

Quality Control for Cell Culture

21

欧美国际相关指南

• USA The U.S. Department of Agriculture (USDA) regulations for veterinary products as specified in the 9CFR 113

regulations (9CFR). (FDA)

• FDA The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform

Encephalopathy(BSE) in FDA-Regulated Products for Human Use Guidance for Industry - The Sourcing and

Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy(BSE) in

FDA-Regulated Products for Human Use

• ICH VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF

HUMAN OR ANIMAL ORIGIN Q5A(R1)

• ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug

Products: Chemical Substances

22

EMEA有关指南

Adventitious Agents Safety Evaluation

• Viral Safety Development of a Guideline on Viral Safety Evaluation of Biotechnological Products

to be used in Clinical Trials(CHMP/BWP/124447/04)

• Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal

Products(CPMP/BWP/1793/02 )

• Quality of Biotechnological Products: Viral safety Evaluation of Biotechnology Products derived

from Cell Lines of Human or Animal Origin (CPMP/ICH/295/95 ICH Topic Q5A)

• Virus Validation Studies: The Design, Contribution and Interpretation of Studies validating the

Inactivation and Removal of Viruses(CPMP/BWP/268/953AB8A )

23

EMEA有关指南

Transmissible Spongiform Encephalopathies (TSE) ( Animal and Human )

• Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and

Veterinary Medicinal Products, Amendments to section 6.2 and 6.3.(EMEA/410/01 Rev. 2 )

• Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant

materials(EMEA/22314/02 )

• Public Report on Risk and Regulatory Assessment of Lactose and other products prepared using

Calf Rennet(EMEA/CPMP/BWP/337/02 Final )

• Joint CPMP/CVMP Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform

Encephalopathy Agents via Human and Veterinary Medicinal Products(EMEA/CPMP/BWP/498/01 )

• Public Statement on the Evaluation of Bovine Spongiform Encephalopathies ( BSE ) - Risk via the

Use of Materials of Bovine Origin in or during the Manufacture of Vaccines

(EMEA/CPMP/BWP/476/01 )

• Explanatory Note: Gelatin for Use in Pharmaceuticals (EMEA/430600/00 )

• Position Statement on Polysorbate 80 (CPMP/BWP/1952/98 )

• Position Paper on Production of Tallow Derivatives for Use in Pharmaceuticals(CPMP/1163/97 )24

欧洲药典的有关规定

EP9.0

Raw materials of biological origin for the production of cell-based and gene therapy medicinal producs

适用范围：

•血清和血清替代品

•重组蛋白制品（生长素、细胞素类、激素、酶类、单抗制品）

•生物材料提取蛋白（酶、多克隆抗体）

包括：

•来源

•生产工艺（外源因子去除灭活工艺＼工艺验证＼外源因子检查）

•鉴别

•检查

25

动物来源辅料控制要点Animal-derived excipients control points

生产起始材料的控制 Control of production starting materials

• 明确动物的种类 Confirm animal species

• 动物种群的筛选 Screening of animal populations

• 饲养设施和环境 Rearing facilities and the environment

• 动物的健康状况 Animal health

• 动物免疫接种 Animal immunization

• 日常病原体的监测 Daily pathogen monitoring

• 相关机构出具的动物检疫检验合格证明 Animal quarantine inspection certificate issued by relevant agencies

• 动物脏器提取的操作过程 Animal organs extraction operation procedure

• 脏器、收集、保存运输等过程 Organ, collection, preservation and transportation process

• 投产前，还应对动物脏器进行严格的筛选 Animal organs should also be strictly selected before the production

• 独立的或最小混合量的脏器单元进行外源因子筛查 Exogenous factor screening on individual or minimal mixed organ units

• 加强对供应商的审计 Strengthen supplier audit 26


工艺过程控制Process control• 工艺验证 Process Validation

• 稳定性 Stability

• 批间一致性 Inter-batch consistency

• 确定工艺关键质控点 Determine the process critical control points

• 建立相应的理化特性，以保证工艺处理效果 Establish the appropriate physical and chemical characteristics, in order to ensure the result of process

• 加强中间品外源因子污染的检查，工艺过程的控制可能比成品控制更有效 Inspection of exogenous pollutants in the intermediate, process control may be more effective than the finished product control

• 工艺前的质量控制以及工艺后的效果评估 Pre-process quality control and post-process evaluation

• 生产工艺及质量控制趋势分析 Production process and quality control trend analysis

• 符合药品或辅料的生产管理规范（GMP）Compliant with the pharmaceutical or excipient good manufacturing practices (GMP)

• 避免制备过程中可能引入外来的污染因子 Avoid the possible introduction of external pollution factors in the production process

• 防止生产过程中批与批之间造成的的交叉污染的潜在风险 Prevent potential risks of cross-contamination between batches in the production process

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建立可靠的病毒灭活工艺 Establish a reliable virus inactivation

process

• 建立适宜的病毒灭活工艺，最大程度地杀灭或去除已知或未知的外源因子 Establish

appropriate virus inactivation process, to kill or remove known or unknown

exogenous factors to the greatest extent

• 有效的病毒灭活验证 Valid virus inactivation verification

• 病毒灭活效果的评价 Evaluation of virus inactivation result

• 病毒灭工艺对成分的影响 The impact of virus inactivation process on components

28

质量控制方法Quality control

• 理化检验方法 Physical and chemical test methods

– 方法的建立 Method establishment

– 方法的适用性 Method suitability

• 方法的验证检测方法 Method validation

– 灵敏度 Sensitivity

– 专属性 Specificity

– 非单一性 Non-exclusivity

– 综合评估 Comprehensive Evaluation

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外源因子风险的防控屏障Prevention and control of exogenous factor risk

动物控制 Animal control

原料控制 Raw material control

工艺控制 Process control

灭活工艺后的控制 Control after inactivation process

成品控制 Finished product control

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成分的控制 Control of components

• 产品中成分的控制 Control of components in the product

• 杂质／残留物质的控制 Control of impurities/residuals

• 有风险物质的检测和安全限度的制定 Detection and set safety limit for risk materials

• 工艺过程中使用试剂的残留量的控制 Control of reagent residual in production process

各成分稳定性控制Stability control of all components

• 包装 Packaging

• 保存运输 Storage and transportation

• 使用效期的制定 Setting the expiration period

• 使用过程中的可能的影响 Possible influence during the use

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药用辅料标准数据库建立Establishment of a pharmaceutical excipients standard database

32

Number of Monographs

主要内容Main

content


工作进展

Progress

面临

挑战Challenges

工作展望Work

prospects

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我国药用辅料相关法规及技术文件China's laws, regulations and technical documents for pharmaceutical

excipients 《药品管理法》第四条：生产者生产产品所使用的原料、辅料、添加剂、农业投入品，应当符合法律、行政法规的规定和国家强制性标准。

2004年6 月《国务院对确需保留的行政审批项目设定行政许可的决定》（国务院令第412号），明确保留了“药用辅料注册”，并设定为行政许可项目

2004年，SFDA发布《药用辅料生产质量管理规范》的征求意见稿

2006年，药用辅料GMP正式颁布，并作为指导性文件，要求行业参照执行，并非强制要求。

2005年6月21日， SFDA 发布了《药用辅料注册申报资料要求》（临时性文件）

2005年年9月，SFDA 发布了《药用辅料管理办法》（讨论稿）

2010年9月， SFDA发布了《药用原辅材料备案管理规定》（征求意见稿），2011年11 月，再次就此公开征求意见，但还未正式发布实施。

2012 年6月1日，SFDA 发布了《加强药用辅料监督管理的有关规定》（征求意见稿）规定于2013年2月1日正式实施。

2016年1月12日药包材药用辅料关联审评审批申报资料要求（征求意见稿）

2016年5月12日发布药用辅料、药包材与药品关联审评审批的公告（征求意见稿）

2016年5月12日发布药用辅料、药包材与药品关联审评审批的公告（征求意见稿）

2016年8月10日正式发布药用辅料、药包材与药品关联审评审批的公告

2017-5-11-总局关于征求《关于鼓励药品医疗器械创新加快新药医疗器械上市审评审批的相关政策》（征求意见稿）意见的公告（2017年第52号）

2017-5-22 药包材药用辅料关联生平射你政策解读(一)

面临挑战 Challenges

• 产业水平不高 Low level of industry capability

• 研究基础薄弱 Weak research foundation

• 供需分离信息不对称 Uneven supply and demand information

• 管理模式有待转变 Administration mode to be changed

• 质量评价标准合理性 Quality evaluation standards and its rationality

• 产品内在品质 Product intrinsic quality

• 质量控制的方式 Quality control approaches

• 。。。。

药用辅料标准体系Pharmaceutical excipients standard system

药用辅料通则

高风险制剂使用

普通制剂使用

注射剂、吸入制剂眼用制剂等

总体要求

化学合成、半合成

天然物质

植物来源

动物来源

炮制辅料

药用辅料原料

工艺过程成品包装运输

供应商的审计质量控制动物植物来源

控制外源因子控制

工艺过程控制中间品质量控制动物来源材料病

毒灭活验证要求杂质、有关物质

的控制工艺稳定一致性

药用辅料标准药用辅料命名、名

词术语红外鉴别光谱稳定性评价功能性评价辅料分批要求杂质有关物质控制

包装要求贮藏运输要求

使用

药用辅料生产管理规范GMP

（高风险、口服、外用制剂。。。）

新辅料生物安全评价指导原则

制剂

聚合体

大分子

共处理

预混

关联审批相关技术要求

药用辅料品种遴选原则Selection principles of pharmaceutical excipients

• 国内批准上市的国内外制剂中使用的药用辅料，安全性得到证实；The excipients used in

imported drug products which have been approved in China, the safety has been

confirmed;

• 对不同制剂应用的需要，应制定相应标准的药用辅料 Appropriate standards should be

developed to meet the need for different formulations

• 国家药品监管部门认为有必要制定国家标准的药用辅料 National drug regulatory authorities

believe it is necessary to develop national standard of specific pharmaceutical

excipient

• 药典委员会各专业委员会审议认为需制定国家标准的药用辅料Pharmacopoeia Committees

consider the need to develop a national standard of specific pharmaceutical excipient

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药用辅料、药包材与药物关联质量控制评价体系Pharmaceutical excipients, drug packaging materials

and drug quality control evaluation system


活性物质API

药包材Packaging

• 药物和药包材相容性compatibility

• 药物与药包材安全性safety

• 药包材适用性suitability

• 药物与药包材稳定性stability

• 药包材可提取物extractable

• 药物和药用辅料相容性compatibility

• 药用辅料适用性 suitability• 药物与药用辅料安全性 safety• 药用辅料与药物稳定性

stability


• 药用辅料配伍禁忌incompatibility

• 药用辅料之间相容性compatibility

• 辅料雨辅料的稳定性stability

• 辅料的规格适用性suitability

• 药用辅料与药包材相容性compatibility

• 药用辅料与药包材适用性suitability

• 药用辅料与药包材的安全性safety

• 药用辅料与药包材稳定性stability

• 药包材可提取物 extractable

38

谢谢大家！

药用辅料药典标准规划及工作进展 chinese pharmacopoeia …

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