EU: Singapore Added to List of Recognised Third Countries for API Importation
The European Commission recognises Singapore’s GMP requirements and regulatory oversight of active substance manufacturers as equivalent to EU requirements. Once the decision enters into force (15 November), Singapore will join the EU list of recognised third countries for the importation of active substances.
The recognition follows a review of documentation submitted by Singapore’s Health Sciences Authority (HSA) and an on-site assessment of the country’s regulatory system. Singapore requested the assessment in February 2025.
Practical implications: Once the listing takes effect, imports of the relevant active substances from Singapore will no longer require written confirmation from the competent authority of the exporting country. This confirmation normally attests that GMP standards and oversight of the manufacturing site are equivalent to EU requirements.
Source:
European Commission: Singapore added to the list of recognised third countries for importation of active substances
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