Lahouari Belgharbi
Scientist, Group Lead of NRA benchmarking, Regulatory System Strengthening (RSS), Essential medicines and Regulation of Health Products (EMP), World Health Organization (WHO)


The World Health Organization (WHO) evaluation of the COFEPRIS as a functional National Regulatory Authority (NRA) in March 2014 has helped WHO to provide an opportunity to build upon the Center of Excellence (CoE) in Good Regulatory Practices (GRP) and Health Sciences, in order to develop regulatory capacity in other non-functional regulatory systems. Moreover this has also opened the pathway for the domestic vaccine industry to become a major supplier of vaccines and contribute by reducing the risk of global supply and the UN SDGs through the global elimination and eradication of the communicable diseases. Worldwide, COFEPRIS is one of the 36 functional NRAs out of the 44 countries currently producing vaccines.



Why is WHO promoting assessment of national regulatory systems?

The need for assuring quality, safety and efficacy of health products is a recommendation of the WHO since the Expert Committee on Biological Standardization (ECBS) and Expert Committee on Pharmaceutical Preparation (ECPP) were established in 1947. WHO recommended the establishment of such oversight through the development of regulatory functions that oversee product’s life. Since 1987 WHO has established a programme to prequalify vaccines (WHO Prequalification Programme) in order to assist member states in purchasing assured quality vaccines for their national immunization programme. This programme relies on an assessed functional regulatory system since 2002, which is one of the requirements for prequalifying vaccines for WHO and United Nations agencies. For this purpose WHO has developed since 1997 global benchmarking assessment tools that address all kinds of health products since 2014 (medicines, vaccines, blood, medical devices) and that document the level of maturity achieved to regulate them. It is expected to have the new model issued by WHO around December 2016.

Concept and process of WHO assessment

The WHO resolutions recommend and support the establishment of functional National Regulatory Authorities (NRA). More specifically this recommendations were reiterated through a new resolution (WHA 67.20) initiated by the Mexican and US delegation at the May 2014 World Health Assembly (WHA 67).This resolution urges the 194 member states and the partners of the global community to promote and continue to assess their regulatory system against the WHO benchmarking system to determine their level of maturity or functionality.

The concept and process of WHO evaluation is built upon a five step capacity building process using a set of functions, indicators and sub-indicators (global benchmarking tool)  initially developed for vaccines (1997), then expanded to medicines (2001) and later to blood and blood products (2009), and more recently to medical devices including diagnostic (2014). The assessment is guided by a quality management system (following ISO principles) leaded by WHO experts assisted by WHO itself and member states experts from already assessed regulatory systems and declared functional by WHO. This allows independent assessment involving experts from other regulatory agencies. In the case of Mexico, WHO conducted two assessment exercises. The first one, in 2009, was not successful. However, after the second assessment in 2014, COFEPRIS was declared as a functional NRA for vaccines. The last assessment involved various experts leaded by WHO in Geneva such as France and Portugal from the European region, US and Brazil from the Americas, Thailand and Indonesia from the Asian region.

The scope of the assessment covers the full product life cycle of vaccines, which is very similar to medicines and blood and partially similar to medical devices. It includes a system component and several regulatory functions such as a) Registration and marketing authorization, b) Pharmacovigilance, including surveillance of adverse events for immunization, c) NRA lot release, d) Laboratory access, e) Regulatory inspections and f) Oversight of clinical trials.

The assessment reviews a wide range of indicators and sub-indicators that are distributed under 9 categories these are:

1. Legal provisions, regulation and guidelines

2. Organization and governance

3. Policy and strategic planning

4. Leadership and crisis management

5. Quality Management System including risk management

6. Regulatory process

7. Resources (Human, financial, infrastructure and equipment)

8. Transparency, accountability and communication

9. Monitoring progress, outcomes assessment and impact final conclusion

At the beginning of the WHO evaluation (1 to 2 years before) a road map is agreed between WHO and the concerned NRA to ensure a successful assessment. For COFEPRIS the road map was developed upon COFEPRIS´s delegation request that visited WHO in March 2013. The road map recommended a series of activities such as learning and training workshops; self-assessment (conducted in Mexico, in August and November 2013); assessments of other NRAs; WHO validation (December 2013; and finally a WHO observed audit (January 2014) and Adverse Events Following Immunization field visit (February 2014).


Outcome of evaluation and consequence at national and global level

Additional recommendations were made that were fully and timely addressed, consequently resulting in a successful assessment for COFEPRIS´s team in March 2014. The results were impressive as all critical indicators were met and a significant proportion of all other indicators (90 to 100%). The evaluation showed a strong leadership and effective management as well as improved communication and transparency directly affecting the quality of services and ethics promoted to meet public and industry expectations. Of course, few recommendations were delivered in order to help COFEPRIS to raise its regulatory capacity and enhance its leadership as innovative and dynamic regulatory system. This was detailed by means of an endorsed Institutional Development Plan (IDP). 

This had another major consequence, not only for the government as regulator, but also for the population in need for increasing access to essential medicines and the industry producing vaccines. This indeed allowed the automatic eligibility of domestic vaccine manufacturers to apply in order to become a quality assured vaccines manufacturer for United Nations agencies. So far, Pan American Health Organization (PAHO) revolving fund, as well as UNICEF is cumulatively delivering vaccines to more than 120 countries. Mexico is becoming a new potential vaccine supplier, contributing to reduce the risk of global vaccine supply disruption as we have seen recently with Yellow Fever and BCC vaccines.




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