To effectively safeguard the drug safety, the pharmaceutical regulation in Taiwan is enforced to monitor the quality and safety of the pharmaceutical products from pre-marketing approval to post-marketing surveillance, through the product life cycle. Pharmaceutical Affairs Act also authorize TFDA to strengthen border inspections and sample testing to prevent counterfeit drugs.

In order to tighten up drug management and to stop illegal drugs from entering the market, the Executive Yuan established an inter-departmental taskforce in March 2010, which included the National Police Agency, the Ministry of the Interior, the Ministry of Justice, the Customs Administration and the Ministry of Health and Welfare. The aims were cracking down on illegal drugs, bringing relevant regulations up to date, monitoring drug advertisements and strengthening public health education. According to studies, the percentage of illegal drugs declines gradually from 27.22% in April 2010 to 0.33% in April 2017.

In 2015, TFDA comprehensively reviewed the Pharmaceutical Affairs Act and revised relevant regulations, sharply increasing fines for counterfeit drugs and adding regulations to address unjustified enrichment and confiscation. A traceability system was established to encourage responsible practices by upstream and downstream manufacturers. This system could track information about manufacturing sources faster, and help to ensure the quality of drugs and their components.

TFDA is using additional strategies to prevent counterfeit drugs, including:

1.     Using big-data analysis to implement cross-comparisons with health insurance claims data to trigger early warnings and monitor abnormal signals.

2.     Strengthening inspections and sampling for high-risk projects, and improving the drug traceability system to prevent counterfeit drugs from entering legitimate supply chains.

3. Promoting Good Distributing Practices (GDP) to ensure product quality and safety.

To avoid the hazards of counterfeit drugs, TFDA also promotes drug safety awareness through a range of outreach activities that share information on how to buy safe medical products and how to avoid counterfeit drugs. Websites also provide the public with relevant information on counterfeit drugs and drug safety. TFDA will continue to work with inter-departmental agencies to effectively fight against illegal drugs to achieve the goals of protecting consumer.