浅析中国原料药登记现状及管理制度挑战——基于反垄断的视角.pdfVIP

浅析中国原料药登记现状及管理制度挑战——基于反垄断的视角

华焱钊，谢金平，邵蓉(中国药科大学药品监管科学研究院，南京

211198)**

摘要：目的

基于反垄断视角分析中国原料药登记现状及管理制度面临的挑战，探讨中国原料药领域垄断案件频发的原因

与影响，并提出优化建议，以促进中国原料药行业公平竞争和药品供应稳定。方法基于国家药品监督管理局公开数据、

垄断案件统计数据，采用描述性统计分析及政策文本分析，系统研究中国原料药登记及管理制度现状、市场结构特征及垄

断行为诱因。结果截至2024年底，中国48.4%的已批准原料药品种由不超过3家企业生产，24.7%为独家生产；

39.9%的原料药需求者数量高于供给者(平均比率4.1倍)，垄断案件频发主因包括准入壁垒高、权属不清、供应链权力结

构失衡等，导致价格暴涨、研发能力削弱和药品供应不稳定。结论建议明确原料药产品所有权人、缩短“I状态”供应

商变更审批时长、分类优化市场竞争环境，以期破解垄断困境，保障药品可及性与行业高质量发展。

关键词：原料药；反垄断；关联审评审批；市场集中度；供需失衡；管理制度优化

中图分类号：R951文献标志码：A文章编号：1007-7693(2025)10-1675-07

DOI:10.13748/ki.issn1007-7693

引用本文：华焱钊,

谢金平,

邵蓉.

浅析中国原料药登记现状及管理制度挑战——基于反垄断的视角[J].

中国现代应用药学,

2025,

42(10):

1675-1681.

AnalysisoftheCurrentStatusofActivePharmaceuticalIngredientRegistrationandManagementSystem

ChallengesinChina:AnAntitrustPerspective

**

HUA

Yanzhao,

XIE

Jinping,

SHAO

Rong(InstituteofRegulatoryScienceofChinaPharmaceuticalUniversity,Nanjing

211198,China)

ABSTRACT:OBJECTIVE

This

study

aims

to

analyze

the

current

status

of

active

pharmaceutical

ingredient(API)

registration

and

the

challenges

faced

by

the

regulatory

system

in

China

from

an

antitrust

perspective.

It

seeks

to

explore

the

reasons

behind

the

frequent

occurrence

of

monopoly

cases

in

the

API

sector

and

their

impacts,

while

proposing

optimization

recommendations

to

promote

fair

competition

and

ensure

the

stable

drug

supply

in

Chinas

API

industry.

METHODS

Utilizing

publicly

available

data

from

the

National

Medical

Products

Administration

and

monopoly-case

statistics,

this

research

employs

descriptive

statistical

analysis

and

policy

text

analysis

to

systematically

investigate

the

current

state

of

API

registration

and

regulatory

systems,

market

structure

characteristics,

and

the

underlying

causes

of

monopolistic

behaviors.

RESULTS

By

the

end

of

2024,

48.4%

of

approved

API

varieties

in

China

were

produced

by

no

more

than

three

manufacturers,

wit