
Taiwan
Regulatory . Certification . Licensing . Assurance
Our Markets
Why Taiwan
Taiwan's pharmaceutical market, valued at $2.9 billion in 20212, is heavily reliant on imported drugs. The market is driven by increasing social awareness of health and well-being, a growing aging population, government efforts to promote foreign investment, and rapid improvements in healthcare technology.
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The pharmaceutical landscape in Taiwan is a dynamic and evolving sector, regulated by Taiwan's Food and Drug Administration (FDA). The FDA ensures that all pharmaceutical products available in Taiwan meet stringent standards of quality, safety, and efficacy.
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However, the regulatory landscape, including the Pharmaceutical Affairs Act, presents challenges. These include stringent compliance with good manufacturing practices (GMP), preparing and submitting necessary documentation in local Taiwan traditional language, and sometimes need for local clinical trials.



As the FDA strives to uphold international standards, instilling confidence in both local and foreign brands, understanding the myriad of regulatory guidelines in Taiwan is vital for companies entering the pharmaceutical market.
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Successfully navigating these regulatory complexities is crucial for tapping into the potential of Taiwan's pharmaceutical industry. This ensures the safe and effective interplay between imported and local drugs, without compromising on quality. As such, Taiwan presents a compelling opportunity for pharmaceutical companies looking to expand their global footprint.