The TFDA regulates drug advertising in Taiwan to ensure promotional content is truthful, non-misleading, and aligned with approved drug information. Advertisements must not exaggerate benefits or minimize risks. Some materials require pre-approval, and the TFDA monitors compliance through inspections and reviews to... Read More
The TFDA regulates drug advertising in Taiwan to ensure all promotional materials are accurate, truthful, and not misleading. Advertisements must align with approved drug information and avoid overstating benefits or downplaying risks. The TFDA monitors compliance through inspections and reviews, requiring companies... Read More
Drug imports in Taiwan are regulated by the TFDA to ensure safety, efficacy, and compliance with Good Manufacturing Practice (GMP). Importers must obtain an import license and submit necessary documentation, including product details, certificates of origin, and GMP compliance. The TFDA may... Read More
Taiwan’s Pharmaceutical Affairs Act grants data exclusivity to encourage innovation. New drugs with novel ingredients receive three years of exclusivity, preventing others from using their data for generic registration. Modified or new indications can receive two years if submitted within two years... Read More
Taiwan aligns its drug registration with international standards by adopting guidelines from the International Council for Harmonisation (ICH) and collaborating with regulatory bodies like the US FDA and EMA. The TFDA ensures compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice... Read More
In Taiwan, bioequivalence studies are required for generic drugs to demonstrate that they have the same bioavailability as the reference product. These studies compare the absorption rate and concentration of the active ingredient in the bloodstream. The TFDA mandates strict compliance with... Read More
In Taiwan, drug recalls are initiated when a product is found to pose a safety risk or fails to meet regulatory standards. Recalls are classified by severity, and the TFDA oversees the process, ensuring manufacturers notify distributors, healthcare providers, and consumers. Compliance... Read More
In Taiwan, the post-market monitoring process ensures drug safety through pharmacovigilance and Periodic Safety Update Reports (PSURs). The TFDA tracks adverse events, conducts inspections, and may require further studies or labeling changes if new risks emerge. This continuous monitoring ensures that drugs... Read More
In Taiwan, orphan drugs are registered through the Taiwan Food and Drug Administration (TFDA). The process involves submitting documentation for clinical trial data, safety, and efficacy. Fast-track approval is available for rare diseases, and sponsors can receive incentives like fee reductions and... Read More
In Taiwan, the Drug Registration Certificate serves as official authorization from the TFDA, confirming that a drug meets regulatory standards for safety, efficacy, and quality. It allows the product to be legally marketed and distributed. The certificate requires periodic renewals, and any... Read More