NASENI-TROMENT Biotechnologies Advances WHO Pre-Qualification Process for N-CheckUp Diagnostics

NASENI-TROMENT Biotechnologies has confirmed that its application for WHO Pre-Qualification (WHO PQ) for the N-CheckUp diagnostic product line is progressing through its final stages. WHO Pre-Qualification is the internationally recognised standard required before diagnostic products can be procured by major global health agencies.

What WHO Pre-Qualification Means

The WHO Prequalification Programme for In Vitro Diagnostics assesses the quality, safety, and performance of diagnostic products intended for use in countries with limited laboratory infrastructure. Products that receive WHO PQ approval become eligible for procurement by UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Médecins Sans Frontières (MSF), USAID, PEPFAR, and the African Union health procurement systems.

For NASENI-TROMENT, WHO PQ would transform N-CheckUp from a nationally registered product into a globally procurable tool — opening a market that amounts to hundreds of millions of diagnostic tests purchased annually by international health organisations.

The Regulatory Pathway

The WHO PQ process for in vitro diagnostics involves a technical dossier submission, a site inspection of the manufacturing facility, and performance evaluation studies. NASENI-TROMENT’s strong existing certification base — ISO 13485, ISO 9001 (US-notified body), and NAFDAC — has provided a solid foundation for the WHO PQ application.

The company also holds product registration dossiers in Germany, the United States, Turkey, and Western Europe — further strengthening the technical package submitted to the WHO.