Preclinical & Clinical Trial Requirements
Preclinical and clinical trial requirements in Panamanian Pharma – an overview. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.
Preclinical & Clinical Trial in Panama are regulated on Law 1 January 10, 2001; Law 78 November 20, 2003; Law 84 of May 14, 2019; Executive Decree 1110 June 6, 2012; Resolution No. 512 of June 28, 2019; Executive Decree 1843 December 16, 2014.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, it is not a requirement to conduct the clinical trials for products locally. Moreover, clinical trials are only required when the product is an innovative product and new indications not contemplated in the accepted references for the Ministry of Health.
2. How are clinical trials funded?
If clinical trials are conducted by a public entity, the trial is funded by the government, included in the annual state budget.
In a private entity, the clinical trials are funded by sponsorships or donations. The amount is not regulated but it is verified by the Committee.
In all cases it is mandatory “informed consent” duly signed by participant.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The requirements for pre-clinical and clinical trial protocols are going to depend on the type of product/device or subject on trial.
4. What are the requirements for consent by participants in clinical trials?
The consent must be obtained through an informed consent form in Spanish accompanied with a description of the process used for obtaining and documenting the informed consent.
5. May participants in clinical trials be compensated?
Compensation is not forbidden.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Participants are covered by the required insurance to the clinical trial. If any harm arise that it is not covered by the insurance clause and was not consent, participants have the right to initiate any civil and criminal legal action.