Once the coronavirus vaccine is designed in a laboratory, it must be shipped to every country, and before it reaches patients, it must go through the relevant regulatory agency. They review medications, issue approvals, licenses, and provide the public with medical information. Upon achievement of this process -if the entity approves the medication- patients will have access to the vaccine.
Each country worldwide has its own regulatory agency in charge of regulating medicines, vaccines, biological products, medical devices, cosmetics, dietary supplements, among others. One of the best known agencies is the United States Food and Drug Administration (FDA); in Colombia there is INVIMA, in Peru it is called Dirección General de Medicamentos, Insumos y Drogas and in Mexico it is the Comisión Federal para la Protección Contra Riesgos Sanitarios.
In the case of COVID-19, once the vaccine or treatment is available, every country in the world will seek its prompt procurement, and this poses a challenge to those countries’ regulatory agencies, as they will have to work quickly, with lots of pressure and under global and regional coordination. To accelerate this process, platforms as Access to COVID-19 Tools (ACT Accelerator), signed by the European Union, CEPI and IFPMA, have been created to boost promptness and efficiency around anti-coronavirus medications.
Regarding the role of regulatory agencies, the Drug Information Association (DIA), an international organization encouraging innovation in the healthcare sector, invited Cammilla Horta Gomes, Latin America Regulatory Policy Lead at Roche, to participate in a podcast where she explained the response of the region’s agencies.
Horta Gomes, who served the Brazilian regulatory agency for 14 years, explained that “crises are generally unpredictable, multilayer, and involve multiple stakeholders “, so agencies must become flexible in this changing ecosystem without leaving rigor, safety and efficiency aside. In order to adapt to this new reality, each regulatory agency has a different approach to the challenges posed by the pandemic, such as new protocols, applications and urgent demands and the integration of technology in the processes. Failure to adapt, could endanger the access of products thus affecting the entire population.
Countries as Peru and Uruguay are accepting electronic formats of applications for medicines and vaccines, while countries like Colombia and Chile are trying to implement electronic signatures to carry out online procedures. Furthermore, agencies are having regular meetings with local associations to update themselves on local measures of each place.
However, according to Gomes, the health emergency situation “is exposing inequalities that exist in our region, we have big differences in the structure, the organization and in the resources, that each regulator has to work in this time of crisis”. This makes some entities unable to operate remotely because they either depend on printed documents or do not have the necessary equipment. Then, the only solution is to close or restrict activities to the minimum.
As to such inspections conducted by regulatory agents on laboratories, Gomes explains that the entities are depending on “reliance and recognition as an alternative.” Since travelling is impossible, remote inspections are being performed or certificates are being granted with greater flexibility. The same happens for clinical trials, where there is a current need of approving them quickly, especially when it relates to COVID-19.
Similarly, the agencies have chosen to announce that they will take longer to deliver regulatory responses to new medicines; in the long term, says Gomes, this could directly affect patients with other diseases “in an unpredictable way”.
Now, a topic of interest today is coronavirus tests that must go through regulatory agencies. The most important thing is that tests should be of good quality, but with so many tests in the market, agencies can choose to rely on the decisions made by other regulators when procuring the tests. “No matter what the strategy is, adapting transparency here (in the lists they publish) is the key element”, explains Cammilla Gomes. Using information from other regulatory agencies may also be helpful to continue supplying other coronavirus-related and non-coronavirus related medications.
In summary, regulatory agencies are experiencing an unprecedented collaborative momentum. Although this collaboration came out from a specific need, Cammillla Gomes hopes that this repeats over time and not only with the healthcare sector. Each Latin-American country has something unique to contribute with; now it only remains trusting each other.