Singapore Added to the List of Recognised third Countries for Importation of APIs
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On 26 October 2026, the Commission adopted a decision that the regulatory framework for active substances, including rules on good manufacturing practice (GMP), in the Republic of Singapore is equivalent to that in the EU. This decision allows the EU to rely on the quality oversight of active substances produced in Singapore and helps to improve the supervision of the quality of medicines in the EU.
The last country added to this list was Taiwan in November 2023.
Third countries may ask the Commission to assess whether their regulatory framework, together with the related control and enforcement activities concerning active substances, ensures a level of public health protection equivalent to that of the Union. Such recognition streamlines export procedures to the EU while maintaining an adequate level of GMP oversight. The Republic of Singapore requested such an assessment in February 2025.
The review of the relevant documentation submitted by Singapore's Health Sciences Authority (HSA), together with an on-site review of the country's regulatory system, was successful. Once the Commission Implementing Decision enters into force, Singapore will join the list of recognised third countries.
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