Special Section: Latin America
El Salvador’s Progress toward Innovation in Medicines Regulation
Interview with National Director of Medicines Noe García

he National Directorate of Medicines (DNM) is the national regulatory authority of El Salvador. Created in 2012, the DNM is the competent health authority for authorizing the registration, import, manufacturing, price control, and monitoring of the supply chain until the sale to the final consumer of medicines and related products in the country. In recent years, the agency has become one of the most active regulators in Central America and has made important advances towards more agile regulation in collaboration with regional and international partners. In this interview, National Director of Medicines Noe García shares the agency’s history, challenges, and opportunities.

DIA: The DNM is recognized as a forward-thinking regulatory authority in Central America. What measures have they implemented that have improved its efficiency?

Noe García: As a regulatory agency, our starting point was to perform a self-diagnosis focused on how regulatory activities were being carried out at that time and taking into account our institutional mission and vision.

From that point on, the DNM reoriented our objectives to establish different strategies aimed at strengthening regulatory activities and providing a better service to users and the general population. We based these strategies on:

  • Constantly monitoring the response time of the procedures established by the DNM.
  • Establishing achievable goals to reduce the response times of these procedures.
  • Simplifying procedures: Reviewing internal procedures to eliminate unnecessary requirements, eliminating information requirements from the institution’s records, and updating technical criteria.
  • Recognizing decisions of reference regulatory agencies (reliance) and applying this to the evaluation processes.
  • Digitalizing and automating services, helping to optimize time and resources in daily operations for both the DNM and the regulated industry.
  • Strengthening DNM staff competencies through ongoing training supported by PAHO and other organizations.
  • Establishing a training plan to guide the regulated sector on the DNM’s activities and procedures, leading to continuous feedback for both parties where one learns from the experiences of both the regulator and the regulated.

DIA: What has DNM learned during its work to strengthen the regulatory system? What is the benefit for the healthcare ecosystem?

NG: The institution learned that dialogue is always important, which requires listening to the needs of all involved sectors to properly focus regulations governing those sectors while keeping in mind our responsibility to protect the health of the population. During development of health regulations, we exchange ideas, problems, and needs with stakeholders such as the private, public, academic, and healthcare professional sectors, to raise awareness on the subject under consideration with a positive impact on public health. These interactions also provide insights into international regulation and recommendations from the World Health Organization (WHO) to be incorporated into these processes, which in turn strengthens the technical capabilities of stakeholders.

El Salvador National Director of Medicines Noe García
El Salvador National Director of Medicines Noe García
The benefits of these mechanisms to strengthen health regulations are aimed at ensuring that the population has high-quality, effective, and safe health products, and that there is legal security for all stakeholders in accordance with clear regulations that are in line with the reality of the country. These benefits are also strengthened by the continuous improvement process, our constant search to identify opportunities for correction and adjustments in the generation of business, products, and services in which the DNM is involved. The pharmaceutical industry in El Salvador is one of the most important industrial sectors, as the volume of exported pharmaceutical products has been stable for the last three years.
DIA: How does DNM visualize the collaborative work between the National Regulatory Agencies of the Central American region? What recommendations can you share with other countries that are beginning their journey towards strengthening their regulatory system?

NG: The DNM has led the effort to strengthen the regulatory system in the Central American region with a busy agenda, which included visits to most of the representatives of our regulatory counterparts with the main objective of working in a coordinated way, as well as to promote an exchange of experiences to save time and facilitate the mechanism of adjustments and corrections in their processes, having a self-diagnosis as the starting point. It is very important to have an open dialogue to generate an exchange of experiences with regulatory agencies to strength our respective institutions.

Following these visits, DNM continues to work closely with the Central American National Regulatory Agencies by providing technical support, as exemplified by visits we have received from delegations of regulators from Guatemala and Honduras, which have addressed strengthening pharmaceutical legislation, health surveillance, and related issues.

DIA: What future challenges do DNM and other regulatory authorities in Central America identify for their work?

In a globalized world, where technology is driving innovation faster and impacting the regulatory environment, the questions ahead for a national regulatory authority are represented by the challenge of ensuring timely access to quality, safe, and effective medicines.

In this sense, challenges are centered on the fact that, globally, regulatory agencies and industry must incorporate new technologies into their processes. This is the reason why DNM has started its path towards digitalization. This step is important because it enables people to implement and accept electronically signed digital documents issued by other agencies such as the European Medicines Agency (EMA), the US Food and Drug Administration (US FDA), Health Canada, the National Institute for Food and Drug Surveillance (INVIMA) of Colombia, or Mexico’s Federal Commission for Protection from Health Risks (COFEPRIS). Each of these agencies serves as a reference to others to support Pan American Health Organization (PAHO) efforts to strengthen other NRAs in the region; to be an example of best practices and other regulatory innovations; and to support leveraging decisions from other regulatory authorities (reliance).

This entails paradigm changes, adaptation to new technologies, investment in the development of computer systems and in cybersecurity, and interconnectivity between the systems of the regulatory authorities with the systems of:

  • Other health entities and authorities.
  • The authority responsible for the registration of natural and legal persons and companies: to ensure that the companies interacting with the regulator are allowed to conduct business/operations in their jurisdiction.
  • Customs: to ensure that all regulated imported products have been duly authorized by the health authority.

For all this, the National Directorate of Medicines of El Salvador is working on innovation projects to incorporate new technologies into our procedures so that we can provide more efficient services and contribute to the development of a safe and healthy country.

The next goal outlined in the DNM work plan is to become a competent and efficient Regional Reference Authority, which aims to improve the performance of certain health regulatory functions recommended by PAHO/WHO to ensure the efficacy, safety, and quality of medicines in El Salvador.

Read Part 1 of Global Forum‘s Special Section on Research and Regulation in Latin America in our previous issue.