A new Biomedical Research Regulation of the Costa Rican Social Security Fund was published on 10 March 2021. The new regulation incorporates internationally recognised standards in the field of medical research involving humans, such as the Guideline for Good Clinical Practice which are consistent with the principles stated in the Declaration of Helsinki. The provisions of the new regulation also consider the existing national Biomedical Research Regulatory Law No 9234 of 7 April 2014 and the subsequent regulatory amendments.

The Costa Rican government suspended all clinical trials in the country in 2010 due to concerns that clinical trials were not adequately regulated, resulting in the closure of 20 private research centres and more than 12,000 patients not being able to participate in clinical trials. In April 2014, the Biomedical Research Regulatory Law No 9234 was enacted, allowing Costa Rica to resume clinical research activities. However, the medical research environment has not gained the potency that existed before all clinical trials halted. 

With the new Biomedical Research Regulation coming into force, it is hoped the country will become a location to provide patients with new modern treatments and allow participation in all the processes of innovative medical care, including research, development, and pre-commercialisation of clinical trials.

Safety concerns may have put clinical trials on ice in Costa Rica, while other countries constantly look at ways to adapt their clinical trial programmes to keep people safe. Find out more about clinical trial regulations with Axco's clinical trial market reports.