Tue, Apr 22, 2025 page2

• Drug review processes to be shortened, FDA says

  REACTION TO TARIFFS: Depending on what countries have approved a medicine, its review process could be completed as fast as in 120 days, an FDA official said

  • By Esme Yeh / Staff writer, with CNA
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  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.

  

  A US flag flutters with a People’s Republic of China coat of arms in the background in an undated photograph.

  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.
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