A stark debate over who owns the data in the future of AI and digital health emerged at the World Health Organization (WHO) Executive Board on Wednesday. Low and middle-income countries warned that the rapid deployment of new technologies risks accelerating data extraction and increasing inequality, cautioning that – without strict AI governance, sustainable financing […] Continue reading ->
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly established new AI principles in drug development to reduce regulatory divergence between the major markets of the European Union and the United States. Industry associations have applauded the landmark accord, as it strengthens harmonisation across the regions – but emphasise […] Continue reading ->
Following eleven hours of intense negotiations overnight, the European Union (EU) clinched a landmark agreement on the most significant pharma reform of its medicines market in over 20 years on Thursday.  Reached in the final moments of the Danish EU Presidency’s mandate, the deal aims to strike a critical balance stimulating pharma innovation, particularly for […] Continue reading ->
The World Health Organization (WHO) has designated government regulatory authorities in Canada, Japan, and the United Kingdom as WHO-Listed Authorities (WLAs), a status granted to national authorities that meet the highest international regulatory standards for medical products. The recognition widens the pool of WHO-recognized authorities significantly beyond the previously recognized authorities in Europe, the United […] Continue reading ->
The World Health Organization’s (WHO) vast European region – 53 countries, including the entire European Union, Russia and even Israel – is often excluded from cheaper medicine deals because of member states’ high- and middle-income status. But one of the flagship programmes of WHO regional director Dr Hans Kluge is the Novel Medicines Platform (NMP), […] Continue reading ->
WHO has expanded its list of trusted national regulatory authorities from three to 36 agencies – including the United States Food and Drug Adminstration (FDA), the European Medicines Agency (EMA) as well as the European Medicines Regulatory Network (EMRN), composed of the European Commission, and thirty national regulatory agencies. The WHO Listed Authorities (WLAs) are […] Continue reading ->
Speaking during a tour by WHO’s Director General of Cape Town’s new mRNA vaccine R&D hub that replicated the Moderna COVID vaccine, South Africa’s Health Minister affirms support for the continental-wide medicines regulatory authority.  CAPE TOWN  – South Africa’s Health Minister signalled that his country intends to join the African Medicines Agency – but that […] Continue reading ->
  Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week.   On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty […] Continue reading ->