Peru clinical trial regulatory guide

Regulator: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

Peru offers a growing clinical research infrastructure with competitive costs and an ethnically diverse patient population. DIGEMID oversees clinical trial authorization while INS (Instituto Nacional de Salud) manages trial registration. Peru is particularly attractive for trials requiring diverse demographic enrollment.

Approval process

1. Ethics Committee Approval. Submit to an INS-registered institutional ethics committee (CEI).
2. INS Registration. Register the clinical trial with the National Institute of Health (INS).
3. DIGEMID Authorization. Submit clinical trial application to DIGEMID for regulatory approval.
4. Import Authorization. Obtain import permit for investigational devices.
5. Site Activation. Finalize site agreements and begin enrollment.

Ethics requirements

• INS-registered ethics committee review required
• Informed consent in Spanish per Peruvian regulations
• Participant insurance mandatory
• Continuing review required
• Special provisions for indigenous populations

Documentation requirements

• Clinical trial protocol in Spanish
• Investigator brochure
• Device technical dossier
• GMP/ISO 13485 certificates
• Insurance documentation
• INS registration documentation

Device registration

DIGEMID oversees medical device registration with a risk-based classification system. Registration requires a local representative and typically varies by study (we confirm it per protocol). Peru recognizes international certifications (FDA, CE) as supporting evidence.

FDA acceptance of Peru data

FDA accepts Peruvian clinical data under 21 CFR 812.28 when studies follow ICH-GCP standards. Peru's diverse patient population is particularly valuable for meeting FDA's diversity action plan requirements.

Key contacts

• DIGEMID — General Directorate of Drugs, Supplies and Drugs
• INS — National Institute of Health

Frequently asked questions

What role does INS play in Peru?

INS manages clinical trial registration and oversight, while DIGEMID handles regulatory authorization for medical products.

Is Peru good for diverse enrollment?

Yes, Peru offers one of the most ethnically diverse populations in LATAM, valuable for FDA diversity requirements.

How do costs compare?

Peru offers lower costs compared to the US and is competitive with other LATAM markets.

Can Peruvian data support FDA submissions?

Yes, FDA accepts Peruvian data when generated under ICH-GCP and ISO 14155 protocols.

What are Peru's key challenges?

Longer regulatory timelines and the dual INS/DIGEMID process can add complexity compared to single-agency countries.

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