China has signaled a sustained “high-pressure” antitrust enforcement approach in the pharmaceutical sector as it introduces new guidelines to tighten oversight of drug pricing and market conduct.
Pharmaceutical companies in China face sustained antitrust scrutiny, with regulators signaling a “high-pressure” enforcement stance as Beijing rolls out new guidelines to strengthen oversight of drug pricing.
Enforcement will target key categories of drugs — including drugs in short supply, emergency medicines and commonly used treatments — that directly affect patients’ access and interests, Yao Lei, head of the price supervision and anti-unfair competition bureau at the State Administration for Market Regulation, or SAMR, said Wednesday.
The remarks came at a State Council Information Office press conference held to explain new guidelines issued Tuesday by the State Council on improving drug pricing mechanisms.
Yao said authorities will act at the first sign of antitrust violations, move quickly to investigate and impose heavy penalties, targeting companies, organizers and responsible individuals alike.
Since 2023, antitrust authorities have handled 12 cases involving monopoly agreements and abuse of dominance in the pharmaceutical sector, imposing fines totaling more than 2.4 billion yuan ($352 million).
Since 2025, the agency has concluded 28 pharmaceutical merger reviews, helping to safeguard fair competition in the market, Yao said, citing Wuhan Yongtong Pharmaceutical’s acquisition of Shandong Beida Gaoke Huatai Pharmaceutical as an example.
The case involved regulators ordering the unwind of a completed merger that eliminated competition in the Chinese market for papaverine hydrochloride injections, a critical vasodilator used in microsurgery for reattaching severed fingers.
The policy document issued by the State Council sets out measures to improve a market-led pricing mechanism, while reinforcing oversight to promote fair competition and prevent pricing irregularities.
The guidelines also call for action against practices such as exploiting shortages to drive up prices, as well as anticompetitive conduct in drug and pharmaceutical raw and auxiliary material markets.
At the same time, the policy framework includes measures supporting innovative drugs, as the country seeks to balance public interest in drug pricing with the high-quality development of the pharmaceutical industry, which is emerging as a key sector in China’s economy.
The guidelines aim to improve the pricing mechanism for newly launched drugs, allowing companies to assess clinical value, market demand, competitive conditions and affordability when setting prices, with oversight and peer review.
Higher-value innovative medicines may set launch prices in early stages that reflect high development costs and risks, while maintaining relatively stable prices for a certain period.
Additionally, broader payment channels — including commercial health insurance — are expected to support access to such drugs, according to the policy.
Source: MLex
