7月17日至19日，2026中巴医药及医疗健康B2B投资大会如期举办，巴基斯坦药品监督管理局（DRAP）发布专题推介报告，全面解读本国草药与中国传统医药完整监管体系、市场规模、简化审批政策与全产业链合作机遇，明确巴基斯坦已建立专门针对中医药产品的合规准入通道，依托中巴经济走廊打造中医药辐射中亚、中东、非洲的区域出口枢纽。
From July 17 to 19, the 2026 China-Pakistan Pharmaceutical and Healthcare B2B Investment Conference was held as scheduled. The Drug Regulatory Authority of Pakistan (DRAP) issued a special promotional report, providing a comprehensive interpretation of the country's herbal medicine and Chinese traditional medicine complete regulatory system, market size, simplified approval policies, and full industry chain cooperation opportunities. It clarified that Pakistan has established a compliance access channel specifically for Chinese medicine products, leveraging the China-Pakistan Economic Corridor to create a regional export hub for Chinese medicine covering Central Asia, the Middle East, and Africa.
一、市场体量庞大，传统医药消费需求旺盛
巴基斯坦拥有2.55亿人口，本土草药产业根基深厚：国内注册草药生产商598家、注册进口商992家，在册草药产品超10.8万款，国内市场90%草药供给由本土企业完成，本土草药市场规模约16亿美元。
放眼全球草药赛道，2026年全球草药市场规模达2710亿美元，行业预测2034年将增长至5150亿美元，2026至2034年复合年增长率约8.3%，增长空间广阔。庞大消费基础、持续走高的市场增速，为中国传统医药出海提供充足市场土壤。
1. Large Market Size and Strong Demand for Traditional Medicine
Pakistan has a population of 255 million, with a well-established local herbal industry: 598 registered domestic herbal manufacturers, 992 registered importers, and over 108,000 registered herbal products. About 90% of the herbal supply in the domestic market is provided by local enterprises, with the local herbal market size around 1.6 billion USD.
Looking at the global herbal sector, the global herbal market is expected to reach 271 billion USD by 2026, with industry forecasts projecting growth to 515 billion USD by 2034. From 2026 to 2034, the compound annual growth rate is estimated to be about 8.3%, indicating vast growth potential. The large consumer base and continuously increasing market growth provide ample market opportunities for Chinese traditional medicine to expand overseas.
二、立法明确中医药合法地位，专属监管规则落地
巴基斯坦以完善法律体系为中医药准入保驾护航：
1. 顶层立法授权：《2012年DRAP法案》明确将中国传统医学纳入“替代药物”监管范畴，赋予DRAP对中医药产品注册、许可、上市全流程管理权限；
2. 专项执行细则：《2014年替代药物及健康产品（注册）规则》细化草药、中医药、尤纳尼、阿育吠陀等传统药品分类管理；2026年全新修订替代药物规则，单独设立中国传统医药专属监管路径；
3. 专职管理部门：DRAP设立健康与非处方药专职部门，统一负责中医药、草药制剂、植物提取物、传统专利药的集中许可与上市审批；
4. 完整配套规范：新版规则共9大章节、34份配套表格，同步出台GMP生产规范、进口仓储标准、委托生产、产品标签等全套附表，覆盖中医药生产、进口、销售全环节合规要求。
II. Legislation Clarifies the Legal Status of Traditional Chinese Medicine and Implements Exclusive Regulatory Rules
Pakistan safeguards the market access of Traditional Chinese Medicine (TCM) through a comprehensive legal system:
1. Top-Level Legislative Authorization: The 2012 DRAP Act explicitly includes Chinese traditional medicine under the regulatory category of "alternative drugs," granting DRAP full authority over the registration, licensing, and marketing processes of TCM products;
2. Special Implementation Rules: The 2014 Alternative Drugs and Health Products (Registration) Rules detail the classification management of traditional medicines such as herbal medicine, TCM, Unani, and Ayurveda; the newly revised 2026 Alternative Drugs Rules establish an exclusive regulatory pathway specifically for Chinese traditional medicine;
3. Dedicated Management Department: DRAP has set up a dedicated department for health and over-the-counter drugs, uniformly handling centralized licensing and marketing approvals for TCM, herbal preparations, plant extracts, and traditional patented medicines;
4. Complete Supporting Standards: The new rules comprise 9 chapters and 34 supporting forms, introducing a full set of schedules covering GMP production standards, import storage requirements, contract manufacturing, product labeling, and all-round compliance requirements for TCM production, import, and sales.
三、简化进口注册流程，明确标准化审批时限
建立基于风险的科学评估机制，为中国中医药企业划定清晰、可预期的办事流程与办理周期，配套数字化改革持续提速审批效率：
进口准入完整流程
中国药企需委托巴基斯坦持证进口商或授权代理机构提交申请、缴纳费用并递交全套资料，监管部门开展质量核查、仓储场地核验后提交专家委员会（EEC）评审；企业若对评审结果存异议，可在60日内向复审委员会提交申诉。
半自动化系统标准办理时限
·生产许可证、进口许可证：约90个工作日
·进口替代药物（含中医药）产品注册：约90个工作日
·本土替代药物注册：约180个工作日
·出口专用产品注册：仅15个工作日
·产品变更申请：约30个工作日
3. Simplify the import registration process and clarify standardized approval timelines
Establishes a risk-based scientific assessment mechanism, providing Chinese traditional medicine companies in China with clear and predictable procedures and timelines, while the accompanying digital reforms continuously accelerate approval efficiency:
Complete import entry process
Chinese pharmaceutical companies need to entrust a licensed Pakistani importer or authorized agent to submit applications, pay fees, and provide a full set of documents. Regulatory authorities conduct quality inspections and warehouse site verification before submitting to the Expert Evaluation Committee (EEC) for review; if the company has objections to the review results, it can appeal to the Re-evaluation Committee within 60 days.
Semi-automated system standard processing timelines
·Manufacturing License, Import License: about 90 working days
·Import-substitute drugs (including traditional Chinese medicine) product registration: about 90 working days
·Local substitute drug registration: about 180 working days
·Export-specific product registration: only 15 working days
·Product change application: about 30 working days
同时巴方推进三大改革缩短审批周期：全流程数字化申报系统、业务集中处理平台、扩充审评人员编制；面向中方企业开放申报前沟通会议，提前梳理材料、规避注册风险。进口许可审批严格以GMP合规、产品质量评估为核心判定标准。
At the same time, the Pakistani side is advancing three major reforms to shorten the approval process: a fully digitalized declaration system, a centralized business processing platform, and an expansion of the number of review personnel; pre-submission communication meetings are opened to Chinese enterprises to sort out materials in advance and avoid registration risks. Import permit approvals strictly use GMP compliance and product quality assessment as the core judgment criteria.
四、全产业链投资合作机遇全面开放
面向中国传统医药企业开放全价值链合作赛道，核心合作方向包括：中医药成品进口落地、草药原料与标准化提取物联合开发、中巴联合新药研发、中医药临床数据互认提交、生产工厂投资与技术转让、委托代工生产、中医药人才教育培训，同时支持中方企业依托巴区位优势，打造面向中亚、中东、非洲的传统医药出口集散中心。
4. Comprehensive Opening of Investment and Cooperation Opportunities Across the Entire Industry Chain
Opening the full value chain cooperation opportunities to Chinese traditional medicine enterprises. The core areas of cooperation include: the landing of imported finished traditional Chinese medicine products, joint development of herbal raw materials and standardized extracts, Sino-Pakistani joint new drug research and development, mutual recognition and submission of clinical data for traditional Chinese medicine, investment in manufacturing plants and technology transfer, contract manufacturing, and education and training of traditional Chinese medicine talents. At the same time, Chinese enterprises are supported in leveraging Pakistan's regional advantages to build export distribution centers for traditional medicine aimed at Central Asia, the Middle East, and Africa.
五、多重政策加持，打造中医药友好投资环境
巴基斯坦将医疗健康产业列为国家经济发展优先板块，配套多重投资便利化机制：
1. 依托SIFC国家投资便利化委员会，实现多部门协同服务；
2. 政策持续扶持高附加值传统医药制造，鼓励本土产业增值；
3. 产业发展规划与中巴经济走廊一体化目标深度契合；
4. 持续推进监管数字化改革，简化外资企业准入、注册、变更全流程手续。
V. Multiple Policies Supporting the Creation of a TCM-Friendly Investment Environment
Pakistan has listed the healthcare industry as a key sector for national economic development and has implemented multiple investment facilitation mechanisms:
1.Relying on the SIFC National Investment Facilitation Committee to achieve coordinated services across multiple departments;
2.Policies continue to support high value-added traditional medicine manufacturing and encourage local industry value enhancement;
3.Industrial development planning is deeply aligned with the integration goals of the China-Pakistan Economic Corridor;
4.Continuously promoting digital regulatory reforms to simplify the full process of foreign enterprise entry, registration, and modification procedures.
六、行业展望：巴基斯坦成为中医药区域战略支点
凭借清晰的中医药专属监管框架、庞大本土消费市场、连通多国的地理区位优势，巴基斯坦将成为中国传统医药走向南亚及周边市场的核心战略平台。巴方将持续优化传统医药审批流程、完善产业配套，欢迎国内中医药企业深度开展全链条长期战略合作。
6. Industry Outlook: Pakistan Becomes a Regional Strategic Hub for Traditional Chinese Medicine
With a clear regulatory framework dedicated to traditional Chinese medicine, a large domestic consumer market, and a geographical advantage connecting multiple countries, Pakistan will become a core strategic platform for Chinese traditional medicine to enter South Asia and surrounding markets. Pakistan will continue to optimize the approval process for traditional medicine, improve industry support, and welcome domestic traditional Chinese medicine companies to engage in deep, full-chain long-term strategic cooperation.
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.