China accelerates approvals for innovative, urgently needed drugs

China approved the market entry of 48 innovative drugs in 2024, covering a broad spectrum of diseases, as part of efforts to accelerate drug approvals and improve patient access to new, high-quality treatments, the National Medical Products Administration (NMPA) said on Tuesday.

The NMPA released its 2024 Drug Review Annual Report on the day, revealing significant progress in accelerating the approval of new and essential medicines. In 2024, the country granted approval for 48 first-class innovative drugs, covering nearly 20 therapeutic areas such as oncology, neurological disorders, endocrine diseases, and anti-infectives.

"For drugs with high clinical urgency, the NMPA has established several channels that facilitate their market entry. For example, drugs undergoing the priority review and approval procedure now have their review time reduced from the usual 200 working days to just 130. In 2024, NMPA included 124 applications for priority review, covering 88 drug varieties, marking a 14-percent increase from the previous year. Additionally, 110 drugs were approved under this expedited process, involving 74 drug varieties, representing a year-on-year increase of more than 29 percent," said Yuan Lijia, a staff member with the business management division of the center for drug evaluation under the NMPA.

The report also highlighted the NMPA's push to fast-track approvals for urgently needed medications, particularly those for rare diseases and pediatric use. In 2024, 55 drugs for rare diseases (excluding class-four generic drugs) and 106 pediatric drugs were approved.

Besides, the availability of drugs in short supply has also improved significantly. In 2024, NMPA approved 117 drugs with supply gaps, encompassing 21 varieties. Over the past five years, a total of 226 drugs in short supply have been approved, covering 12 medical fields, including circulatory and neurological diseases.

The NMPA also made strides in approving breakthrough therapies. In 2024, the agency received 337 applications for breakthrough therapeutic drugs and granted approval to 91, marking a 30 percent increase compared to the previous year.

"NMPA has established four processes facilitating the market entry of drugs, including breakthrough therapy process, conditional marketing authorization, priority review and approval and special approval. The priority review process, for example, covers drugs in short supply with high clinical urgency, innovative and improved treatments for major infectious diseases and rare conditions, pediatric drugs, and innovative vaccines," Yuan stated.

China accelerates approvals for innovative, urgently needed drugs

Iranian Foreign Minister Seyed Abbas Araghchi said on Monday that the situation in Iran is "under total control" following violence linked to protests that spiked over the weekend.

Addressing foreign diplomats in Tehran, the foreign minister noted that armed terrorist groups had infiltrated the protests, attempting to divert them from their legitimate course. He claimed that evidence has been gathered showing Iranian security forces being shot at, with the aim of causing further casualties. He accused the United States and Israel of exploiting the unrest to interfere in Iran's internal affairs.

Araghchi further stated that the government is closely monitoring developments on the streets, emphasizing that "the situation has come under control." He also affirmed that internet services, curtailed during the unrest, would be restored after coordination with security agencies.

The government has engaged in dialogue with merchants and protest representatives and initiated reforms to address grievances related to price hikes and currency depreciation. Iran has taken a series of actions and measures to respond to the demands of peaceful demonstrators, the foreign minister said.

Earlier on Sunday, Araghchi said that clear evidence links recent riots and vandalism of public facilities in Iran to the Israeli intelligence agency Mossad. This came after former U.S. Secretary of State Mike Pompeo mentioned Mossad agents operating on Iran's streets in a social media post. The Iranian foreign minister asserted that police are being attacked by "terrorists" acting under the direction of Israeli operatives, whom Pompeo publicly acknowledged.

The protests initially erupted over a sharp depreciation of the rial and sweeping subsidy reforms. Iranian authorities have blamed the unrest on foreign-linked agents and U.S. sanctions.

Iranian foreign minister says situation "fully under control," accuses Israeli intelligence of stoking unrest