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Commission recognises Singapore's active substance GMP framework as equivalent to the EU's

🇪🇺 European Commission (DG SANTE) · Wed 28 Oct 2026

A Commission decision adopted on 26 October 2026 adds Singapore to the list of recognised third countries for importing active substances, once the implementing decision enters into force.

The European Commission adopted a decision on 26 October 2026 finding that Singapore's regulatory framework for active substances, including its rules on good manufacturing practice (GMP), is equivalent to the EU's. DG SANTE announced the move in its 28 October newsletter.

The Commission says the decision lets the EU rely on the quality oversight of active substances made in Singapore. It adds that this helps improve supervision of the quality of medicines in the EU.

Singapore asked for the assessment in February 2025. The Commission reviewed documentation submitted by the Health Sciences Authority (HSA) and carried out an on-site review of the country's regulatory system. The Commission describes the outcome as successful.

Singapore will join the list of recognised third countries once the Commission Implementing Decision enters into force. The announcement does not give a date for that.

By way of context, third countries can ask the Commission to assess whether their regulatory framework and related control and enforcement activities give a level of public health protection equivalent to the EU's. According to the Commission, recognition streamlines export procedures to the EU while keeping an adequate level of GMP oversight.

What it means for your team

  • Importers and manufacturers sourcing active substances from Singapore should monitor when the Implementing Decision enters into force, as listing depends on that.
  • Quality and supply-chain teams should check how recognition affects their documentation and import arrangements for Singapore-made active substances, using the Commission's page on listing of third countries.
  • The Commission presents recognition as streamlining exports to the EU while maintaining adequate GMP oversight, so the decision concerns reliance on Singapore's oversight rather than any relaxation of GMP expectations.

Official source: European Commission (DG SANTE) ↗

Article written by VigiEye from the official source (European Commission (DG SANTE)). AI-assisted; check the source before acting.

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