What Is the Role of a National Regulatory Agency?

What is the role of a national regulatory agency? It is a question that has no answer in the regulations, decrees or laws that each country has in force. Many times, we come across regulatory challenges and questions raised by the pharmaceutical industry, other health institutions and even citizens themselves, who do not have an unequivocal answer.

The regulations that govern each country can indicate the functions and scope of the national regulatory agencies (NRA), both for medicines and medical devices, but the function that these fulfill is adjusted over time.

In many seminars and forums, there is talk of regulatory convergence and reliance on the part of public institutions, but there little acknowledgement that  first progress must be made toward convergence on the part of the pharmaceutical and medical device industries, so that the delivery of documentation and information is the same as that available in the country of origin or first marketing authorization. On more than one occasion, what a pharmaceutical company or a medical device company reports to the US FDA or EMA is different from what is delivered to regulatory agencies in Latin America and, furthermore, they criticize that these health authorities do not grant marketing authorization, alluding to the fact that this authorization has already been granted by the US FDA or by the EMA.

This means understanding the role and responsibility of the national regulatory agencies that must deliver guarantees of quality, safety and efficacy to their population and that for this they need to have information and back it up with evidence and documents. Regulatory agencies must, for example, be clear that the legal representative of the foreign affiliate will be responsible for withdrawal instructions due to quality failures and that they will be responsible for adequate pharmacovigilance and technovigilance, as the case may be, in addition to being responsible for and responding to the transfer processes, especially when the product is thermolabile or may be altered by changes in pressure or by the movement of the means of transport, distribution and storage in the country of destination.

Trust must be achieved not only in aspects of health authorization, but also in relation to the technical documents of pharmacovigilance and technovigilance, health alerts, market control, inspection and audits. This confidence must be oriented in two directions, ascending and descending, since we must trust the function and action of the national regulatory agencies of reference and also those that are in the process of being referential.

I mention the above because it is not possible for all agencies to be at the same level. Some will advance by joining forums, such as the "International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)," the "Pharmaceutical Inspection Co-operation Scheme (PIC/ S)” or the “International Medical Device Regulators Forum (IMDRF),” all highly qualified and referential memberships for those of us who are not yet part of them. Others will be part of the Pan American Network for Drug Regulatory Harmonization (PANDRH Network) and recognized as a Level IV Agency by the Pan American Health Organization and, therefore, as part of the agencies recognized by the World Health Organization (WHO) Still others will be in certification and recognition processes; however, we all have the same obligations and functions. We must all guarantee the quality, safety, and efficacy of pharmaceutical products and medical devices, and we must all answer to the public for our actions.

Allow me to give as an example of the above the work of the Public Health Institute of Chile. In Chile, the CoronaVac vaccine from Sinovac Biotech Ltd., a vaccine that uses the inactive virus platform and not messenger RNA, was authorized for use before the World Health Organization prequalified it. Messenger RNA vaccines began their use mainly in the US  and in European countries, while the CoronaVac vaccine was used in countries like Turkey, Indonesia, Brazil, and Chile. The Institute of Public Health authorized its use in January 2021, which allowed the largest vaccination campaign in the country's history to begin in February of the same year, achieving initial coverage of over 90%, resulting in a considerable reduction in deaths from COVID-19 and generating great expectations in the region. The information collected by the Institute of Public Health was shared with countries, such as Uruguay, which also achieved great coverage. Uruguay does not have a national regulatory agency and its Ministry of Health relied on our assessment. 

Subsequently, Brazil increased the age range of use for the child population, taking into account the studies conducted in Chile and the information used and evaluated by the Institute of Public Health to authorize its use in minors. All of the above occurred before a good supply of messenger RNA vaccines was achieved, which were later used in Chile mainly as a booster, allowing for greater effectiveness against COVID-19. Finally, the WHO prequalified CoronaVac with a history of pharmacovigilance from Chile.
In short, international recognition and external support are essential. In this sense, those who have greater certification or participate in forums of greater relevance and international recognition must provide direct support to the rest and lead the new challenges, so that progress is not the product of a single ARN, but that Latin American agencies are the reference for others, sharing advances, documents and joint evaluations, which will promote the health industry in the region, thereby improving  access to innovative, quality, safe and affordable medicines and medical devices for our beneficiary population.