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TFDA is dedicated to improving the regulation of new drug applications

【Update Date:2024-03-18unit:藥品組

Each year, numerous innovative medicinal products are developed around the world. In order to increase the accessibility of new drugs and provide new treatment options for the Taiwan public, TFDA continues to review and improve the regulatory environment of new drug applications (NDA).

The overall process of new drug application has been well-established with constant refinement, considering the increased approval rate and reduced refuse-to-file cases over the past few years. TFDA granted approval to 101 new drugs, including new chemical entities (NCE), new biologics, new dosage forms, new administration doses, and new unit strengths products, during the last year (2023). Of the approved new drugs, 16 are domestic products, and 85 are imported ones. Based on the indication, 20 approved new drugs are used in cancer treatment, while others are indicated for disorders related to the digestive system, blood, metabolism, etc. The availability of new medicines will benefit patients with more diverse therapeutic options. As for the review process of new chemical entities (NCE), TFDA shows comparable approval quantity and efficiency in contrast to those of the regulatory authorities in A10 countries, such as the U.S., EU, and Japan.

Recently, TFDA has announced several guidelines to reinforce the review process of new drug applications. In 2023, drafts for the amendment of "Guidance on NDA for biosimilar products" and the newly established "Guidance on research and development strategies for CAR T cell products" were announced on August 24 and October 4, respectively. In addition, the amended "Guidance on NDA for new botanic drugs" was announced and implemented on January 11, 2024. To cope with the pressing needs in rare disease treatment, TFDA also initiated a pilot program for the designation-with-registration of A10 countries-approved orphan drugs. This 3-year pilot program started on January 1, 2024, aiming to accelerate the review process of said orphan drugs and offer early access to patients.

    TFDA is always dedicated to harmonizing its regulatory environment with international standards. Aside from proactively participating in the APEC and ICH/IPRP events, TFDA seeks to engage in other global regulatory communities. Lately, TFDA has become an associate member of the International Coalition of Medicines Regulatory Authorities (ICMRA), an alliance founded in 2013 that promotes strategic coordination to address emerging medicine challenges. Leveraging enhanced communication and collaboration with foreign governing agencies, TFDA will continue improving the regulation of new drug applications, hence ensuring the public has access to quality medicinal products.