The Ministry of Health has presented a proposal to the Legislative Assembly for the creation of a new Clinical Trials Law aimed at regulating all clinical trials conducted in the country. The draft bill outlines the role of the Superintendency of Health Regulation as the primary body responsible for enforcing the regulations.

The proposed law seeks to cover clinical trials related to medicines, nutritional supplements, pharmaceutical products, medical devices, advanced therapies, products without a medical purpose, health technologies, and cosmetic products intended for human use. Its main objective is to protect the rights, well-being, and safety of participants while ensuring the integrity of the data collected during these trials.

According to the draft bill, any public or private entity wishing to conduct a clinical trial must seek approval from the Committee on Ethics of Health Research. In addition, these entities will be subject to supervision throughout the process by the Superintendency of Health Regulation, ensuring transparency and adherence to good clinical practices.

The law also emphasizes promoting the availability and proper use of products and guaranteeing the overall transparency of the clinical trial processes. The regulatory body’s proposal has already been submitted for review and approval by the Health, Agriculture, and Environment Commission, with discussions having commenced last Monday.

If passed, this law will represent a significant step forward in strengthening the oversight of clinical trials in El Salvador, providing better protection for participants and enhancing the credibility of the country’s research processes.