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.
The inspection equipment and data transmission system for new robotic dogs that Taipei is planning to use for sidewalk patrols were developed by a Taiwanese company, the city’s New Construction Office said today, dismissing concerns that the China-made robots could pose a security risk. The city is bringing in smart robotic dogs to help with sidewalk inspections, Taipei Deputy Mayor Lee Ssu-chuan (李四川) said on Facebook. Equipped with a panoramic surveillance system, the robots would be able to automatically flag problems and easily navigate narrow sidewalks, making inspections faster and more accurate, Lee said. By collecting more accurate data, they would help Taipei
TAKING STOCK: The USMC is rebuilding a once-abandoned airfield in Palau to support large-scale ground operations as China’s missile range grows, Naval News reported The US Marine Corps (USMC) is considering new sites for stockpiling equipment in the West Pacific to harden military supply chains and enhance mobility across the Indo-Pacific region, US-based Naval News reported on Saturday. The proposed sites in Palau — one of Taiwan’s diplomatic allies — and Australia would enable a “rapid standup of stored equipment within a year” of the program’s approval, the report said, citing documents published by the USMC last month. In Palau, the service is rebuilding a formerly abandoned World War II-era airfield and establishing ancillary structures to support large-scale ground operations “as China’s missile range and magazine
A 72-year-old man in Kaohsiung was sentenced to 40 days in jail after he was found having sex with a 67-year-old woman under a slide in a public park on Sunday afternoon. At 3pm on Sunday, a mother surnamed Liang (梁) was with her child at a neighborhood park when they found the man, surnamed Tsai (蔡), and woman, surnamed Huang (黃), underneath the slide. Liang took her child away from the scene, took photographs of the two and called the police, who arrived and arrested the couple. During questioning, Tsai told police that he had met Huang that day and offered to
A British man was arrested for attempting to smuggle 14.37kg of marijuana into Taiwan through Taiwan Taoyuan International Airport, Taipei Customs said late yesterday. The man, who arrived from Bangkok at 9pm on Friday, was asked by customs officers to open his luggage during a random inspection, Taipei Customs said in a news release. The passenger, whose identity was not disclosed, refused to open his suitcase and tried to flee the restricted area. He was eventually subdued by three customs officials and an Aviation Police Bureau officer. A later search of his checked luggage uncovered 14.37kg of marijuana buds. The case was handed over
RSS