A new generation of diagnostic tests could save millions of people from deadly diseases like HIV/AIDS and TB in the next few years.
Streamlining the regulatory authorization process for these diagnostics will reduce costs and provide faster access to safe, effective products, which stop the spread of disease and save lives.

Project Purpose:

The London School of Hygiene & Tropical Medicine is working with the Bill & Melinda Gates Foundation, Grand Challenges Canada, ministries of health and the diagnostics community including the Asian Harmonization Working Party (AHWP), the Latin American IVD Association (ALADDIV) and the Pan African Harmonisation Working Party and the Workd Health Organization to assess the regulatory landscape and define a set of regulatory standards and a critical pathway to be applied within a consistent and transparent model framework to streamline and harmonise regulatory approval processes for point-of-care (POC) diagnostics. Partners include the African Union/ NEPAD Planning and Coordination Agency, the East African Community Secretariat, the EAC partner States' National Medical and Public Health Laboratory Regulatory Authorities and the African Society for Laboratory Medicine (ASLM).


It is the responsibility of National Regulatory Authorities (NRAs) to provide safeguards for the safety and effectiveness of drugs, vaccines and medical devices used in a country. Most countries have established a process for reviewing the evidence from drug trials to support the introduction of new drugs. Over time, this has improved the quality of drugs used in developing countries. Unfortunately, apart from tests used for blood banking, regulatory standards and processes are often lacking for in-vitro diagnostics (IVDs). In a survey conducted by the World Health Organization, over 50% of the 85 countries that responded do not regulate IVDs for infectious diseases. As a result, diagnostic tests are often sold and used in most of the developing world without any formal evaluation of their safety and effectiveness. Access to good quality diagnostics in these countries is problematic as companies with good quality tests are often unable or reluctant to compete in a market that is flooded with cheap, poor quality tests.

In countries where there is regulatory oversight, quality standards for clinical trials used to generate data for regulatory approval are variable or overlooked. There are no established criteria for licensing and introducing new diagnostic tests as diagnostic technology assessment programs do not exist in most countries in the developing world. The approval process is costly, can take from 2 to 5 years, and lacks transparency.

We are currently working in five harmonization priority areas

  1. Common Registration File
  2. Quality Systems Audit
  3. Clinical Evidence
  4. Post Market Surveillance
  5. Risk Classification