New drug review processes would be accelerated and completed in 120 days in response to a US plan to raise pharmaceutical tariffs, the Ministry of Health and Welfare said yesterday.
Food and Drug Administration (FDA) Deputy Director-General Wang Der-yuan (王德原) yesterday told a news conference that measures have been taken to optimize new medicine review processes and help pharmaceutical companies obtain drug permit licenses as soon as possible.
Such processes normally take about 360 days to complete, if the new medicine is a new chemical entity (NCE) — a drug with new chemicals as principal components — or a drug made from biological sources, also known as biologics.
Photo: AP
However, NCEs or biologics considered important for pediatric treatments and serious diseases, as well as breakthrough therapies can have their review prioritized, with the process shortened to 240 days, he said.
If an NCE or a biologic has been approved in two of the US, the EU or Japan, it is qualified for a “type 1 express review” and can have its review completed as fast as in 180 days, Wang said.
If it has been approved in the three areas with identical data on chemistry, manufacturing and controls, it is qualified for a “type 2 express review” and its review process could be completed in 120 days, he added.
The ministry would also continue to encourage pharmaceutical companies to diversify sources of bulk drugs or active pharmaceutical ingredients so that they would not rely on a single supplier, he said.
China and India are the two major sources of bulk drugs used in Taiwan’s pharmaceutical industry, he said.
The FDA has requested pharmaceutical companies to evaluate whether they should find more bulk drug sources, Wang said, adding that the agency would prioritize the review of new medicines relying on a single source.
Pharmaceutical companies should also use domestically made bulk drugs, although they are mostly more expensive and less adopted, he said.
The administration has compiled an inventory of all US-made pharmaceutical products and sent a notice to their permit license holders to fully understand the medicine supply chain situation and properly boost domestic medicine stocks, he said.
It would also check stocks of primary medicines, such as anti-cancer drugs, orphan drugs and biologics to promptly initiate an investigation and evaluation whenever there is a potential shortage, he said.
The FDA would ask manufacturers of substitute medicines to increase production, or launch a drug import or manufacturing project, if necessary, he said.
Pharmaceutical companies can propose price adjustments to stabilize the market if changes in the global supply chain cause a surge in drug production costs, he said.
The ministry would continue to promote the application of generic drugs and biosimilars — biologics with similar structure and functions of a reference biologic made by another company — to bolster domestically made new medicines, Wang added.
“China is preparing to invade Taiwan,” Deputy Minister of Foreign Affairs Francois Wu (吳志中) said in an exclusive interview with British media channel Sky News for a special report titled, “Is Taiwan ready for a Chinese invasion?” the Ministry of Foreign Affairs said today in a statement. The 25-minute-long special report by Helen Ann-Smith released yesterday saw Sky News travel to Penghu, Taoyuan and Taipei to discuss the possibility of a Chinese invasion and how Taiwan is preparing for an attack. The film observed emergency response drills, interviewed baseball fans at the Taipei Dome on their views of US President
ECONOMIC BENEFITS: The imports from Belize would replace those from Honduras, whose shrimp exports have dropped 67 percent since cutting ties in 2023 Maintaining ties with Taiwan has economic benefits, Ministry of Foreign Affairs officials said yesterday, citing the approval of frozen whiteleg shrimp imports from Belize by the Food and Drug Administration (FDA) as an example. The FDA on Wednesday approved the tariff-free imports from Belize after the whiteleg shrimp passed the Systematic Inspection of Imported Food, which would continue to boost mutual trade, the ministry said. Taiwan’s annual consumption of whiteleg shrimps stands at 30,000 tonnes, far exceeding domestic production, the ministry said. Taiwan used to fill the gap by importing shrimps from Honduras, but purchases slumped after Tegucigalpa severed diplomatic ties with Taiwan
The Executive Yuan yesterday approved a southwestern extension of the Sanying MRT Line from New Taipei to Bade District (八德) in Taoyuan, with a goal of starting construction by late 2026. The 4.03-kilometer extension, featuring three new stations, will run from the current terminus at Yingtao Fude Station (LB12) in New Taipei City to Dannan Station (LB14), where it will connect with Taoyuan’s Green Line, New Taipei City Metro Corp said in a statement. This extension will follow the completion of core Sanying Line, a 14.29-kilometer medium-capacity system linking Tucheng (土城), Sansia (三峽)
CARGO LOSS: About 50 containers at the stern of the ‘Ever Lunar’ cargo ship went overboard, prompting the temporary closure of the port and disrupting operations Evergreen Marine Corp, Taiwan’s largest container shipper, yesterday said that all crew members aboard the Ever Lunar (長月) were safe after dozens of containers fell overboard off the coast of Peru the previous day. The incident occurred at 9:40am on Friday as the Ever Lunar was anchored and waiting to enter the Port of Callao when it suddenly experienced severe rolling, Evergreen said in a statement. The rolling, which caused the containers to fall, might have been caused by factors including a tsunami triggered by an earthquake in Russia, poor winter sea conditions in South America or a sudden influx of waves,