"Triple alianza": WHO+EMA+FDA

The World Health Organization (WHO) has joined international regulatory bodies in a global collaboration on manufacturing practice inspections.

The WHO will team up with the European Medicines Agency, the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) to develop joint efforts to improve practices at drug manufacturing facilities.

EU Member States and the European Directorate of the Quality of Medicines and Healthcare (EDQM) are also involved in the partnership.

Together, the organisations aim to "share information on inspections, including planning, policy and reports, for manufacturers of active pharmaceutical ingredients (APIs) that are located outside the participating countries". Joint inspections between organisations will also take place.

The WHO’s involvement is part of its Prequalification of Medicines Programme, which aims to provide good quality medicines for everyone, with a focus on medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health in developing nations. (Más)