Preclinical & Clinical Trial Requirements
Bendaña & Bendaña / Nicaragua
A brief overview of the situation regarding preclinical & clinical trial requirements in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
It is not a requirement that they be done locally.
2. How are clinical trials funded?
The Manufacturer Laboratory is responsible for financing all these costs. Once the documents are submitted to the Ministry of Health, clinical studies should be included.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The manufacturing laboratory performs these studies. Once submitted to the Ministry of Health in Nicaragua, they must comply with RTCA 11.03.59: 11 (APPENDIX 1 OF RESOLUTION No. 333-2013 (COMIECO-LXVI), Section 7.11 (Attached document).
4. What are the requirements for consent by participants in clinical trials?
See RTCA 11.03.59: 11 (APPENDIX 1 OF RESOLUTION No. 333-2013 (COMIECO-LXVI), Section 7.11 (Attached document).
5. May participants in clinical trials be compensated?
This depends on the agreement between the laboratory that performs the trial and the participants.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
This depends on the agreement between the laboratory that performs the trial and the participants.
