PharmacovigilanceOfficial

EU and Singapore sign working arrangement on medicines and medical devices cooperation

🇪🇺 European Commission (DG SANTE) · Wed 11 Nov 2026

DG SANTE and the EMA have agreed with Singapore's Health Sciences Authority to exchange information on medicines and medical devices, with immediate effect.

DG SANTE and the European Medicines Agency (EMA) have signed a working arrangement with the Health Sciences Authority (HSA) of Singapore. According to the Commission's health and food safety newsletter of 11 November 2026, it is meant to ease collaboration and information exchange on medicines and medical devices, supporting public health and access to safe, good-quality medical products.

The signatories were Sandra Gallina, Director-General of DG SANTE, Emer Cooke, Executive Director of the EMA, and Adj Prof (Dr.) Raymond Chua, Chief Executive Officer of the HSA.

The arrangement lists three main areas of cooperation. The first is information exchange on product safety, efficacy, quality, clinical-trial authorisation, labelling and policy development. The second is observer and expert participation in each other's scientific committees, multilateral procedures and cluster activities, intended to foster mutual learning and capacity-building. The third is training and knowledge-sharing programmes to build regulatory science expertise and promote best practice in both jurisdictions.

The arrangement applies immediately. It will be reviewed periodically and may be extended or adapted by mutual agreement. The source does not describe operational procedures, timelines or any change to existing authorisation requirements. Working arrangements between regulators are generally frameworks for cooperation rather than approval routes.

What it means for your team

  • The scope covers both medicines and medical devices, including information exchange on product safety, efficacy, quality, clinical-trial authorisation and labelling.
  • Regulatory teams with Singapore filings or trials may see closer EU-HSA contact. The source gives no detail on how, or whether, procedures change.
  • Pharmacovigilance and quality teams should note that product safety and quality are named exchange topics. The source does not specify mechanisms or data types.
  • The arrangement is in effect now and subject to periodic review, so further operational detail may follow.

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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