In eight months, the dam health records of medicines in the Department of Regulation and Control of Pharmaceutical and Related Products it was reduced by 49%, since from six thousand that were in October 2025, by June 24 there were 3,064. 71% corresponds to new drugs; the rest are product renewals and approvals, according to the Ministry of Health.
Édgar González, vice minister of Health Regulation, Surveillance and Control, indicated in an interview with Free press that the use of the SIAMED-WEB digital platform to carry out the procedures would help to further reduce this burden; however, there are “endurance” to use it by the regulated sector.
The health registry is the key that opens the door to the national market. Without it, a product cannot be manufactured, imported or marketed, and it assures the consumer that the medications that you acquire are safe.
The official pointed out that when he took office, in July 2024, the holding was eight thousand files. However, when the deadline for the Law on Simplification of Requirements and Administrative Procedures (Decree 5-2021)—to modernize processes and digitize procedures—up to 22 thousand accumulated, because tariffs were stopped and companies took the opportunity to enter documents, even incomplete ones.
At the end of 2025 they had entered 166 thousand 187 pharmaceutical product files. 80% were approved and there is 13% that still must meet the requirements to receive the health registration.
González indicated that to speed up the procedures, lanes and other internal processes were created that allowed the dam to be reduced to the three thousand files that they have today. In addition, platforms were implemented to simplify procedures.
The time for a medicine to receive health registration varies depending on the nature of the product. For those approved, the process may be more expeditious, because they have approval from reference regulatory agencies, such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
However, there are biotechnological products or vaccines whose evaluation takes more time, since, in addition to reviewing the documentation presented by manufacturers, importers or distributors, the evaluators carry out bibliographic consultations or review information from different sources. regulatory agencies to ensure that the medicine meets standards of safety, quality and effectiveness before obtaining the health registration.
“The times are not the same for all products. This is where we have complaints from some regulated companies who tell us: ‘There are products that are coming out faster,’ but it is because they are of a different nature,” González mentioned.
He added that all medication has to go through the department to obtain the health record; Otherwise, it is withdrawn from points of sale.
“We recognize that we have to improve times, but not everything is on the side of Regulation. A part is on the side of the regulated, who does not attend to the processes and is not aware of their file,” said the official.
Digitization
The vice minister indicated that when they arrived at the Ministry of Health, the development of some digital platforms for the registration of food and establishments—processes that are also carried out in the Department of Regulation and Control of Pharmaceutical and Related Products—was advanced, but the same did not happen with the registration of medicines. An agreement with the Chamber of Industry allowed the system to be modernized to streamline processes.
In parallel with the implementation of a series of parameters supported by regulations and free trade agreements to simplify the evaluation processes, reduce the number of files and create processing lanes according to the degree of complexity, as in the case of biotechnology, last November the digital platform was launched SIAMED-WEBwhich allows not only to shorten times, but also to reduce costs and eliminate bureaucratic processes.
The platform does not allow the entry of incomplete files and validates those that are entered—it verifies that they meet the criteria established in the regulations. In addition, assign the evaluator to continue the process digitally. This reduces deadlines and avoid discretiond about the files.
Another advantage is that it makes it easier for regulated entities to monitor from the platform what stage their file is at. “There is traceability for the user,” said the official.
The platform is in the process of interconnecting with other institutions, such as the Superintendency of Tax Administration (SAT), or allowing online payments to be made.
There is no turning back
The department promotes the use of the platforms, but there is resistance from users, since less than 2% of those who carry out procedures use themand are for related products.
“This is the route for us and for the regulated sector. There should be no turning back on the issue of computerization and digitalization. The platforms must be improved, indeed, but that can only be done if they use them,” he added.
He indicated that they will also allow corruption to be reduced in regulatory procedures, as occurred with the case of remdesivir, which was registered during the covid-19 pandemic in record time and ignoring some requirements.
From this account, the Ministry of Health promotes the use of the platform and evaluates setting deadlines for the entry of physical files, so that the processes are done digitally.
The Department of Regulation and Control of Pharmaceutical and Related Products also controls chemical substances for industrial purposes, such as chemical precursors. Likewise, the operation of pharmaceutical establishments, companies and factories that manufacture pharmaceutical products, pharmacies, imports and exports of medicines and food is authorized. Inspections and certifications of good manufacturing practices are also carried out to guarantee the quality of the products.