The Food and Drug Administration (FDA) announced the successful inclusion of Taiwan to the European Commission’s (EC) list of countries whose regulatory system for active pharmaceutical ingredients (APIs) is recognized to be equivalent to that of European Union (EU) requirements in a press release on Wednesday.
The inclusion is expected to fast-track the entry of Taiwan’s APIs into the EU market. This also increases the global competitiveness of Taiwanese pharmaceutical manufacturers since this removes certification requirements and the regular factory inspections by the EU. In addition, the inclusion affirms that Taiwan’s regulatory standards are in compliance with the EU’s good manufacturing practices (GMPs) making it internationally recognized.
APIs are substances or a mix of substances used in the manufacturing of medicinal products. These can only be exported to the EU from countries with a written confirmation of compliance attesting the GMP standards utilized are equivalent to the EU’s or if the country is included in the EC’s list. At present, only nine countries, including Taiwan have been successfully added to the list with the other countries being Canada, South Korea, Australia, Brazil, Israel, Japan, Switzerland, and the United States.