7月17日至19日,2026中巴医药及医疗健康B2B投资大会在巴基斯坦伊斯兰堡举办,巴基斯坦药品监督管理局(DRAP)现场发布专题推介报告,全面披露本国临床研究产业完整生态、国际化监管体系与对华合作红利,明确巴基斯坦是中国创新药企开展海外临床试验的核心战略落脚点,依托中巴经济走廊(CPEC)搭建深度协同研发平台。
From July 17 to 19, the 2026 China-Pakistan Pharmaceutical and Healthcare B2B Investment Conference was held in Islamabad, Pakistan. The Pakistan Drug Regulatory Authority (DRAP) released a special promotion report on-site, comprehensively revealing the complete ecosystem of the country's clinical research industry, its international regulatory system, and the benefits of cooperation with China. The report clearly indicated that Pakistan is a core strategic location for Chinese innovative pharmaceutical companies to conduct overseas clinical trials, leveraging the China-Pakistan Economic Corridor (CPEC) to build a deeply collaborative research and development platform.
一、庞大临床资源底座,患者招募优势突出
1. Vast clinical resource base, prominent advantages in patient recruitment
巴基斯坦拥有2.55亿人口,存量巨大、未经规范治疗的患者群体,可大幅缩短新药受试者招募周期;产业配套已形成成熟体系:全国持证CRO机构34家、合规临床试验中心137家、生物等效性(BABE)研究中心3家,累计开展106项临床试验、18项BABE研究,已顺利落地70余项国际多中心临床项目。
Pakistan has a population of 255 million, with a large group of patients who have not received standardized treatment, which can significantly shorten the recruitment cycle for new drug trials; the industry support system has formed a mature framework: there are 34 licensed CROs nationwide, 137 compliant clinical trial centers, 3 bioequivalence (BABE) study centers, having conducted a total of 106 clinical trials and 18 BABE studies, and successfully implemented over 70 international multicenter clinical projects.
放眼全球,全球临床试验总量约65000项,其中来自中国申办方的项目达4900余项;而巴基斯坦已承接19项中国药企发起的临床试验,双方搭建起成熟稳定的临床合作通道。全球临床市场规模当前约850亿美元,预计2030年将攀升至1300亿美元,南亚市场增量空间广阔。
Looking at the world, there are approximately 65,000 clinical trials globally, of which more than 4,900 are sponsored by Chinese applicants; Pakistan has undertaken 19 clinical trials initiated by Chinese pharmaceutical companies, establishing a mature and stable channel for clinical cooperation between the two sides. The global clinical market is currently around 85 billion USD and is expected to rise to 130 billion USD by 2030, with significant growth potential in the South Asian market.
二、DRAP接轨国际标准,监管体系高度透明合规
2. DRAP aligns with international standards, with a regulatory system that is highly transparent and compliant
巴基斯坦药品监管依托完善法制框架实现国际化治理,核心法规体系清晰:
Pakistan's drug regulation relies on a well-established legal framework to achieve international governance, with a clear core regulatory system:
1. 《2012年DRAP法案》赋予监管机构临床试验全流程监管权限;
2. 《2017年生物研究规则》强制全面落地ICH国际人用药品注册技术协调会指南;
3. 国内GCP规范完全对标ICH标准,设立专职临床研究委员会负责技术审评,组建专业GCP稽查队伍,全程把控临床试验伦理与操作规范。
1. The "2012 DRAP Act" grants regulatory authorities full-process supervision authority over clinical trials;
2. The "2017 Biological Research Guidelines" mandate the comprehensive implementation of ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines;
3. Domestic GCP standards are fully aligned with ICH standards, with a dedicated Clinical Research Committee responsible for technical review, and professional GCP inspection teams established to fully oversee the ethics and operational norms of clinical trials.
为降低外资准入门槛,DRAP推出系列监管便利化举措:搭建NBC-DRAP一体化数字单一申报窗口,实现线上材料提交、审批进度实时追踪;设立优先审评绿色通道,针对肿瘤、传染病、地方流行病等重点疾病新药大幅压缩审批周期;推行监管互认依赖路径,简化合规材料重复提交流程,同步实现伦理审查与技术审评并行办理,大幅缩短项目落地周期。
To lower the entry barriers for foreign investment, DRAP has launched a series of regulatory facilitation measures: establishing an integrated NBC-DRAP digital single reporting window to enable online submission of materials and real-time tracking of approval progress; setting up a priority review green channel to significantly shorten approval cycles for new drugs targeting key diseases such as cancer, infectious diseases, and local epidemics; implementing a regulatory mutual recognition reliance pathway to simplify the repeated submission process of compliance materials, while simultaneously carrying out ethical review and technical evaluation in parallel, greatly reducing the project implementation cycle.
三、多重投资利好,打造对华友好临床研发沃土
3. Multiple investment benefits, creating a favorable clinical research and development environment for China
报告系统梳理巴基斯坦临床研究七大核心投资优势:
The report systematically outlines the seven core investment advantages of clinical research in Pakistan:
1.成本优势显著:临床开发综合成本具备全球竞争力,同时严格遵循WHO、ICH国际质量标准,兼顾性价比与合规性;
2.疾病谱系匹配:本国高发疾病谱与中国创新药企研发管线高度契合,临床数据具备双向参考价值;
3.区位枢纽价值:地处南亚、中亚、中东交汇核心,临床试验数据可辐射周边多国市场;
4.政府协同机制:SIFC投资委员会、国家卫生部、DRAP、投资发展局(BOI)、国民单一窗口(NBC)多部门联动,一站式解决企业落地各类诉求;
5.前置沟通服务:面向中国申办方、CRO开放申报前科学沟通会议,提前规避方案、注册风险;
6.数字化监管升级:上线统一临床试验注册平台、全流程线上追踪系统,无纸化申报降低运营成本;
7.成熟产业生态:全国布局标准化试验基地、持证本土CRO、国际化培训临床研究者,形成可直接落地的研发配套体系。
1.Significant cost advantage: The overall clinical development costs are globally competitive, while strictly adhering to WHO and ICH international quality standards, balancing cost-effectiveness and compliance;
2.Disease spectrum alignment: The country's high-incidence disease spectrum closely matches the R&D pipelines of Chinese innovative pharmaceutical companies, providing clinical data with bidirectional reference value;
3.Regional hub value: Located at the intersection of South Asia, Central Asia, and the Middle East, clinical trial data can cover surrounding multiple national markets;
4.Government coordination mechanism: The SIFC Investment Committee, Ministry of Health, DRAP, Board of Investment (BOI), and National Single Window (NBC) work together to provide one-stop solutions for various enterprise needs;
5.Pre-communication services: Open scientific consultation meetings before application for Chinese sponsors and CROs to proactively avoid protocol and registration risks;
6.Digital regulatory upgrade: Launch of a unified clinical trial registration platform and full-process online tracking system, with paperless submission reducing operational costs;
7.Mature industry ecosystem: Nationwide deployment of standardized trial sites, licensed local CROs, and internationally trained clinical researchers, forming a research and development support system that can be directly implemented.
四、中巴临床合作未来路线图公布
4. Future Roadmap for China-Pakistan Clinical Collaboration Announced
DRAP在会上明确中长期对华合作五大核心方向,面向中国医药企业开放全链条协同机会:
At the meeting, DRAP clarified five core directions for medium- and long-term cooperation with China, opening full-chain collaborative opportunities to Chinese pharmaceutical companies:
1. 联合发起多中心跨国临床试验;
2. 搭建中巴临床研究者常态化交流机制;
3. 推进医药研发技术双向转让;
4. 开展GCP、临床试验运营联合培训;
5. 建立长期稳定CRO战略合作伙伴关系。
1.Jointly initiate multi-center international clinical trials;
2.Establish a regular exchange mechanism for clinical researchers between China and Brazil;
3.Promote bidirectional transfer of pharmaceutical R&D technologies;
4.Conduct joint training on GCP and clinical trial operations;
5.Establish long-term and stable strategic partnerships with CROs.
茂本公司(中国)是一站式综合经贸服务企业,核心覆盖境内外会展全流程运营、大宗商品双向贸易、全球跨境供应链配套、海外投资项目四大核心业务。
公司依托成熟的海内外产业资源网络,深度联动中国-非洲、中国-巴西、中国-东南亚等市场工商协会、产业园区与政企平台,可为中外企业提供国际展会策划招商、B2B供需对接、粮油/机电/新能源/医药等品类大宗贸易撮合、国际物流清关仓储、海外投资调研、PPP项目规划、外资落地合规代办一体化解决方案,助力国内企业出海拓市,同步引进海外优质农副产品、特色产业资源对华流通,深度服务中巴经济走廊跨境经贸与双边产业合作。
Mallbem Company (China) is a one-stop comprehensive economic and trade service enterprise, with core businesses covering four major sectors: full-process operation of domestic and overseas exhibitions, two-way bulk commodity trade, global cross-border supply chain supporting services, and overseas investment projects.
Relying on a mature network of domestic and international industrial resources, the company deeply connects business associations, industrial parks, and government-enterprise platforms in markets such as China-Africa, China-Brazil, and China-Southeast Asia. It can provide an integrated solution for Chinese and foreign enterprises, including international exhibition planning and investment promotion, B2B supply and demand matching, bulk trade matching in categories such as grain and oil, electromechanical products, and new energy, international logistics, customs clearance and warehousing, overseas investment research, PPP project planning, and compliance services for foreign investment localization. This helps domestic enterprises expand overseas markets while simultaneously introducing high-quality overseas agricultural and sideline products and specialty industrial resources to China, deeply serving cross-border trade and bilateral industrial cooperation along the China-Brazil economic corridor.

