Taiwan is stepping up generic drug R&D to enhance the global competitiveness of its pharmaceutical industry. Currently, 11 local companies participate in a program led by the Industrial Development Administration (IDA). The initiative aims to speed up research, development, and commercialization of generic drugs while increasing the sector’s overall value.
Generic drugs, which are off-patent medications, must match original drugs in composition, dosage, safety, and efficacy. The Taiwan Generic Pharmaceutical Association defines these standards clearly. With the global generic drug market valued at $456 billion in 2023 and expected to reach $666.5 billion by 2029, Taiwan sees a significant growth opportunity.
Therefore, the government’s program focuses on advancing generic drug R&D. It prioritizes 505(b)(2) products and modified new drugs. Moreover, it encourages the use of innovative manufacturing technologies to create unique, high-barrier drugs. The program offers preferential pricing policies for the first two approved drugs, helping manufacturers gain permits and grow market share.
Since its launch in 2023, companies such as Yung Shin Pharmaceutical Industrial, Orient Pharma, Standard Chemical & Pharmaceutical, Sinphar Pharmaceutical, and Amed have joined the effort. Their projects cover areas like cancer treatment, psychiatric medications, and hormone and metabolic therapies.
So far, one drug has gained approval, and five more are under review. This progress highlights a growing momentum in high-value drug development. For example, Orient Pharma accelerated clinical trials and regulatory approval to develop an immunomodulatory sustained-release tablet. This innovation enhances patient convenience. Meanwhile, Amed expanded from medical devices into pharmaceuticals, securing Taiwan’s first domestic permit for Sugammadex, an anesthesia reversal agent, through corporate partnerships.
The IDA plans to keep encouraging firms to deepen generic drug R&D. It aims to help companies use cross-sector resources and strengthen Taiwan’s pharmaceutical supply chain. Additionally, the program seeks to shift Taiwan’s role from generic drug manufacturing toward branded drug exports. This transition supports industrial upgrading and aligns the local industry with global markets.
