Work in Progress: Regulatory Authority Cooperation 

Stronger Together: How National Regulatory Authorities Can Cooperate for Better Health for All

National regulatory authorities (NRAs) play a crucial role as gatekeepers in the medical product supply chain. They are responsible for ensuring that medicines, vaccines, blood products, medical devices (such as diagnostics), and traditional or herbal treatments, are high-quality, safe, and effective. Strong regulatory systems are an integral part of health systems and make significant contributions to achieving universal health coverage.

As the global medical product supply chain becomes increasingly interconnected, weaknesses in one area can have widespread consequences. In pharmaceutical manufacturing, for example, active ingredients may be sourced from various countries, processed in another, and then distributed globally. This makes the job of an NRA even more important, and more complex.

Working in isolation

Many countries have limited regulatory capacity but they still need to facilitate access

to quality-assured medical products. This is also the case for countries in the Central Asia Regional Economic Cooperation Program (CAREC) program. An expert review of drug regulatory matters and pharmaceutical policy in Afghanistan, Azerbaijan, Kyrgyz Republic, Mongolia, Tajikistan and Uzbekistan, commissioned by Asian Development Bank, found that most CAREC countries rely on imports to meet their medical product needs, and this places a heavy burden on individual country NRAs. While European Union countries have a single agency in charge of the evaluation and supervision of pharmaceutical products–the European Medicines Agency–CAREC country NRAs work in isolation to assess medical products and manufacturing sites before issuing approvals for their own country.

NRAs in CAREC countries lack access to support from international counterparts. For example, none of them are among the 56 members of the Pharmaceutical Inspection Co-operation Scheme, a non-binding, informal co-operative arrangement in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. CAREC NRAs often duplicate work that has already been done by their regional peers. Even worse, different NRAs sometimes come to contradictory conclusions about the same medical product.

Negative consequences

The consequences of this duplication and lack of harmonization are negative for all parties involved. For the population in CAREC countries, it puts hurdles in the way of access to medical products. For the government procurement agencies, it restricts access to the best available information that can inform their decision making. Wherever there is an unmet demand, there will inevitably be alternative supply, which creates opportunities for substandard and falsified medicines to more easily enter the supply chain. For manufacturers, it becomes  uneconomical to sell their products in certain countries because of cost of the registration processes relative to the size of the market.

The expert study found other region-specific anomalies and issues. Many CAREC NRAs test huge numbers of samples, typically 20 times as many samples a year as EU countries test. Only three CAREC countries–Kazakhstan, Pakistan and the People’s Republic of China–have World Health Organization (WHO) prequalified quality control laboratories. These are laboratories that have been assessed, inspected and found to comply with globally recognized good practice standards.

Missed opportunities for cooperation

Some CAREC NRA’s participate in WHO’s collaborative procedure for accelerated registration for WHO pre-qualified pharmaceutical products (Azerbaijan, Georgia, Kazakhstan, Kyrgyz Republic, Pakistan, and Uzbekistan), and Georgia participates in a similar procedure for products approved by a broadly recognized regulatory body such as the EMA, US Food and Drug Administration, Health Canada or Australia’s Therapeutic Goods Administration. However, most products that CAREC NRAs need to assess are not WHO-prequalified, nor are they qualified by the more well-resourced NRAs from outside the region.

Work smarter, not harder

Simply adding more staff or resources will not solve the problem, because it is not possible for every CAREC country to build a regulatory system that can perform all NRA functions at the highest possible level of competence, efficiency, and effectiveness.

However, there are other ways that NRAs can address the problem, starting with applying a risk based approach to testing. Then, they would make best use of their limited resources, focusing regulatory work on products and manufacturers that pose the highest risk. How individual countries would do this depends on the national regulatory system and domestic market, but international experience shows that when an NRA carefully plans a risk-based sampling and testing strategy and has the right regulations in place to support it, resources are optimized. They also increase the probability of detecting and filtering out substandard products before they get into the supply chain.

Secondly NRAs could establish effective collaboration with counterparts in other countries and implement a process called regulatory reliance, i.e., where they rely on the work done by a trusted authority to make their own decisions without duplicating the evaluation work. This is often most appropriate for new and complex medical products, but whatever it is used for, there has to be a regulatory framework on standard procedures for sharing information in place. Alack of this is what holds back many NRAs in less well-resourced settings.

Everyone can benefit

Such collaboration is a long-term project, but it can start with cooperation among countries with similar market landscapes for the assessment of generic goods and manufacturers with a regional presence, and built out from there. As trust between NRAs is built, they can evole from sharing work, to mutual recognition of each others’s decisions.   If NRAs in the CAREC region can establish an operational mechanism for collaboration, it paves the way for one of the stronger NRA’s to gradually become a regional center of excellence for the benefit of all participating authorities.

CAREC country NRAs can also learn from the experience of other harmonization initiatives and other parts of the world including the European Union and Southeast Asia. The next step would be to develop a dedicated IT platform that enables authorities at the regional level to exchange information avoid duplication of work and foster cross reliance. This platform can also be used to disseminate alerts on medicine safety concerns and the presence of falsified and substandard products in the supply chain.

With regional reliance and a risk-based approach reducing the strain of testing away at the national level, NRAs could then prioritize national resources to focus on activities where it is not possible to use reliance. For example, they would be better able to support domestic manufacturers to achieve GMP compliance and also to perform post marketing surveillance pharmacovigilance, and providing the public with unbiased product information.