China Mandates Rigorous Clinical Trials for Traditional Medicine Injections in Historic Regulatory Overhaul

China's traditional Chinese medicine (TCM) injection market, worth hundreds of billions of RMB annually, faces an unprecedented regulatory reckoning as authorities demand modern scientific proof for products that have operated in a regulatory grey zone for decades.

In September and October 2025, China's National Medical Products Administration (NMPA) released two draft regulations that industry veterans describe as the strictest ever written for TCM injections. For the first time, every TCM injection approved before 2019 must undergo rigorous post-market evaluations for both safety and effectiveness.

The sweeping reform comes after years of safety concerns involving these herbal extracts, which are distilled, purified and delivered intravenously like Western drugs. Deaths and severe allergic reactions have been reported across China, including cases involving a toddler in Heilongjiang and clusters of adverse events in hospitals nationwide.

Unprecedented Regulatory Requirements

The new regulations establish a comprehensive evaluation framework that mirrors the development pipeline for new drugs. Companies must begin with pharmaceutical research including chemical fingerprinting, identification of active ingredients and stability testing. Only after passing toxicology and pharmacology reviews can they proceed to clinical phases, culminating in randomized, controlled, multicentre trials.

"These guidelines essentially ask companies to repeat the entire development pipeline under modern drug registration standards," said Qiao Chunsheng, chief executive of Beijing Duheng Zhidao Medical Technology Co. Ltd., a contract research organization specializing in TCM products.

A major change requires companies to justify the need for an injection formulation. If an effective oral medication already exists, higher-risk injectable versions may no longer be acceptable. Many injections used for common ailments such as colds, coughs, or fatigue may be eliminated, while those used for acute cardiovascular events, oncology support or specific pain management may remain.

Massive Market Impact Expected

The stakes are enormous. China has 868 active TCM injection approvals across 127 formulas, made by 186 companies, according to Pharnex Cloud data. Industry observers estimate only one-third will survive the new requirements.

"Only products with annual sales over 100 million RMB are likely to invest in post-market studies," said Qiao, noting that in 2024 alone, 400 drug approvals spanning 48 injection varieties surpassed that threshold.

Compliance costs will be prohibitive for many manufacturers. Analysts estimate a single prospective safety study may require 3,000 patients and cost up to 15 million RMB. A randomized efficacy trial could cost another 25 million RMB. Including pharmaceutical research, regulatory filings and production upgrades, total costs could reach 40 million RMB per product, per indication.

Historical Context and Safety Concerns

TCM injections first emerged during World War II when battlefield infections were widespread and resources scarce. The first product, a bupleurum injection, was developed for mass production by Wuhan Wuyao Pharmaceutical Co. Ltd. in the 1950s. By the 1990s, dozens of varieties filled hospital drug lists.

At their peak, annual usage exceeded 400 million patient visits, with yearly sales reaching hundreds of billions of RMB. However, scale brought risk. From the early 2000s onward, reports of adverse reactions became impossible to ignore. In 2004, one injection caused 18 cases of acute intravascular hemolysis. In 2006, allergic reactions to a Houttuynia injection killed more than ten patients.

"Globally, there is no precedent for injectable formulations made from natural raw materials with such simple processing," said Zhou Chaofan, a researcher at the China Academy of Chinese Medical Sciences and member of the Chinese Pharmacopoeia Commission. "Nor for injections whose active ingredient content only needs to exceed 70% of total solids."

Market Consolidation Already Underway

The TCM injection market has already begun contracting. Hospital sales of products listed in the National Reimbursement Drug List and essential medicines catalogue fell from 21.2 billion RMB in 2016 to 8.6 billion RMB in 2022, with a modest rebound to 10.5 billion RMB in 2023.

Major companies are feeling the impact. In 2024, China Shineway Pharmaceutical Group Ltd. saw sales of its core products—Qingkailing and Guanxinning injections—fall 40.8% and 52.7% respectively. Some companies have exited entirely: Dali Pharmaceutical Co. Ltd., which produces Xingnaojing and Shenmai injections, was delisted in February 2025 after its market cap fell below 500 million RMB.

Industry Views Reform as Survival Opportunity

Despite the challenges, many industry experts view the reform as necessary for the sector's long-term viability. "This isn't a crackdown," said Han Sheng, deputy director at Peking University's International Center for Pharmaceutical Management. "It's a chance for survival."

Academician Zhang Boli, who leads the NMPA's 28-member expert group overseeing the reform, acknowledged the need for consolidation. "Roughly a third of TCM injections should be actively promoted for their clinical effectiveness," he said. "But another third lack both efficacy and safety. The rest must catch up through additional research."

The reform represents a fundamental shift from experience-based to evidence-based medicine for TCM injections. Companies have five years to complete their evaluations or face automatic license revocation, marking the end of an era for products that have operated without modern clinical validation.

"Evidence-based evaluation is no longer optional—it's the future," said Huang Luqi, vice head of the National Administration of TCM, acknowledging that many injections lack international-grade evidence.