PIC/S establishes cooperative agreement with African Union Development Agency
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently announced a new agreement with the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) to share information on good manufacturing practices (GMP) for pharmaceuticals and active pharmaceutical ingredients (APIs). The agreement aims to enhance capacity building for GMPs among African national regulatory authorities (NRAs).AUDA-NEPAD has also been granted the status of associate member, which is the first step towards becoming a PIC/S Participating Authority.
The scope of cooperation agreement includes facilitating pre-accession and accession processes to PIC/S for NRAs that are members of the African Medicines Agency (AMA), providing training for inspectors, and participating in each other’s meetings.
AUDA-NEPAD announced that “this partnership marks a significant milestone in advancing Good Manufacturing Practices (GMP) within Africa’s pharmaceutical landscape, ensuring higher quality medicines for the continent’s population.”
The agency said the African Medicines Regulatory Harmonization (AMRH) GMP Technical Committee (GMP TC) plays a “crucial role” in conducting regulatory inspections and in developing technical guidelines. Currently, AMRH is conducting a number of GMP inspections, both mock and actual inspections, which focuses on the continental assessment and listing of medicinal products.
Yet African NRAs need enhanced capacity to establish inspection systems that fulfill strict quality standards. The agency announced that this new agreement between AUDA-NEPAD and PIC/S “aims to fill this gap.”
Nardos Vekele-Thomas, CEO of AUDA-NEPAD stated that “this cooperation agreement is a transformative leap for Africa’s pharmaceutical sector. Strengthening GMP standards will not only ensure the production of high-quality medicines but will also build confidence in our regulatory systems. This is a vital step toward achieving the Agenda 2063 goal of a healthy and well-nourished population.”
AUDA-NEPAD will be given an “official welcome” at the next PIC/S meeting, which will be held on 14 April in Geneva.
PIC/S announcement; AUDA-NEPAD announcement
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