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China enforces 2025 pharmacopoeia to tighten drug supervision

China

China

China

China enforces 2025 pharmacopoeia to tighten drug supervision

2025-10-01 15:12 Last Updated At:15:37

The 2025 edition of the Pharmacopoeia of the People's Republic of China officially came into effect on Wednesday, marking a major step of the country in strengthening drug quality and safety oversight.

As the core of China's pharmaceutical standards system, the pharmacopoeia serves both as a "protective wall" safeguarding public medication safety and a "compass" guiding the development of the country's pharmaceutical industry.

The 2025 edition is divided into four volumes covering traditional Chinese medicine, chemical drugs, biological products, pharmaceutical excipients and packaging materials, as well as general technical requirements. A total of 6,385 products are now listed, an increase of 159 new entries and 1,101 revisions compared to the previous edition. In addition, 69 new general technical requirements were introduced and 133 updated, while 33 new guiding principles were added and 17 revised.

"Regarding the inclusion of varieties, we have focused on enhancing coverage of items listed in the National Essential Medicines List and the National Reimbursement Drug List. This time, the number of general technical requirements and guiding principles added or revised accounts for about 55 percent of the total, further improving drug quality controllability," said Shu Rong, secretary-general of the Chinese Pharmacopoeia Commission.

As the fundamental benchmark for pharmaceuticals in China, the pharmacopoeia sets the minimum threshold for market entry. Under the Drug Administration Law, medicines whose ingredients do not match the prescribed standards are classified as counterfeit, while those that fail to meet specified content requirements are deemed substandard.

"Starting from October 1, drug prescriptions in China, as well as registration applications, production processes and inspections related to active pharmaceutical ingredients, excipients, and packaging materials, must all comply with the new edition of the pharmacopoeia," said Xu Miao, chief expert at the National Institutes for Food and Drug Control (NIFDC).

China enforces 2025 pharmacopoeia to tighten drug supervision

China enforces 2025 pharmacopoeia to tighten drug supervision

The Navy of Iran's Islamic Revolution Guards Corps (IRGC) said that the Strait of Hormuz has been blocked since Saturday evening and will not reopen until the United States lifts its naval blockade on the waterway.

In a statement carried by its official news outlet Sepah News, the IGRC said that the move came after the United States violated its commitments under the two-week ceasefire, which took effect on April 8, and failed to end its naval blockade against Iranian vessels and ports.

The IRGC Navy called on all vessels and their owners to follow official updates via its channel and VHF Channel 16, the international maritime distress, safety, and calling frequency. The statements by U.S. President Donald Trump hold no credibility in the strait and the Gulf, it added.

The IRGC warned that no vessel should move from its anchorage in the Gulf or the Gulf of Oman, and any approach to the strait would be deemed "cooperation with the enemy" and targeted accordingly.

Tehran's political leadership echoed the IRGC's firm position. Parliament Speaker Mohammad Bagher Ghalibaf asserted that the Strait of Hormuz is under Iran's control, revealing that during previous negotiations, Iran had firmly countered U.S. attempts to carry out minesweeping operations, which Tehran viewed as a ceasefire violation.

He said the situation had come close to conflict, but the U.S. had eventually backed off.

Calling the U.S. maritime blockade "reckless and ignorant," Ghalibaf warned that passage through the strait would certainly be restricted if Washington does not lift the blockade.

Underpinning these public announcements, Iran's Supreme National Security Council on Saturday affirmed the country's resolve to exercise control and supervision over traffic through the Strait of Hormuz until the war is definitively ended and lasting peace is achieved in the region.

For its part, the United States pressed ahead with its own military measures.

The U.S. Central Command (CENTCOM) said in a statement on Saturday that the U.S. military is imposing a maritime blockade on ships entering and exiting Iranian ports and nearby coastal areas. Since the blockade began on April 13, 23 ships have complied with U.S. directions to turn around.

Meanwhile, the U.S. military is preparing in the coming days to board Iran-linked oil tankers and seize commercial ships in international waters, The Wall Street Journal reported on Saturday, citing U.S. officials.

The move will enable the U.S. to take control of Iran-linked vessels around the world, including ships carrying Iranian oil that are already sailing outside the Persian Gulf and those carrying arms that could support Tehran, the report said.

Iran's IRGC says Strait of Hormuz blocked, demands end to US naval blockade

Iran's IRGC says Strait of Hormuz blocked, demands end to US naval blockade

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