INHRR Venezuela: Everything Sponsors Need to Know About the National Regulatory Authority
A comprehensive profile of INHRR — Venezuela's national regulatory authority — covering its history, structure, fee schedules, inspection process, and what international sponsors need to know.
June 19, 2026
14
min read
By
bioaccess® Editorial Team
INHRR Venezuela
Instituto Nacional de Higiene Rafael Rangel
Venezuela regulatory authority
clinical trial regulation Venezuela
INHRR fee schedule
**Key Takeaways**
- • INHRR is Venezuela's national regulatory authority for clinical trials and pharmaceutical products
- • Fee: VES 52,612.41 for Phase I-III clinical trial registration (2025 rates)
- • Review timeline: 8-16 weeks for clinical trial authorization
- • SACS: Separate medical device registration with ~20 business day approval
- • Post-approval: Ongoing safety reporting and inspection compliance required
What is INHRR?
The Instituto Nacional de Higiene Rafael Rangel (INHRR) is Venezuela's national regulatory authority responsible for the evaluation, authorization, and oversight of clinical trials, pharmaceutical products, biologics, and vaccines. Named after the renowned Venezuelan bacteriologist Dr. Rafael Rangel, INHRR operates as a technical institute under the Ministry of Popular Power for Health (MPPS).
For international sponsors planning clinical trials in Venezuela, INHRR is the primary regulatory counterpart — equivalent to the FDA in the United States, COFEPRIS in Mexico, or INVIMA in Colombia.
History and mandate of INHRR
INHRR was established as Venezuela's reference laboratory and regulatory authority, with a mandate to protect public health through the scientific evaluation of medical products and clinical research. The institute's core responsibilities include:
- Evaluating and authorizing clinical trial protocols for drugs, biologics, and devices
- Quality control and batch testing of pharmaceutical products
- National reference laboratory functions for infectious diseases
- Post-marketing surveillance and pharmacovigilance oversight
- GMP inspection of pharmaceutical manufacturing facilities
- Import authorization for investigational and commercial medical products
Organizational structure
INHRR is organized into several technical divisions that handle different aspects of regulatory oversight:
- Division of Clinical Trial Evaluation — reviews CTA applications and monitors ongoing studies
- Division of Pharmaceutical Quality Control — tests drug quality and GMP compliance
- National Reference Laboratories — diagnostic and epidemiological reference services
- Division of Biologics and Vaccines — specialized review for biological products
- Division of Post-Marketing Surveillance — monitors safety of approved products
Clinical trial oversight at INHRR
INHRR's clinical trial authorization process involves a comprehensive review of the protocol, investigator qualifications, informed consent procedures, and safety data. The review pathway includes:
- Administrative completeness check of the CTA submission
- Scientific review by medical and pharmacological specialists
- Safety data evaluation (preclinical and any available clinical data)
- Ethics committee approval verification
- Investigator and site qualification assessment
- Investigational product quality review (GMP documentation)
For detailed guidance on the submission process, see our complete INHRR regulatory process guide.
Fee schedule (2025 rates)
INHRR publishes official fee schedules for clinical trial registrations and other regulatory services. As of 2025:
| Service | Fee (VES) | Notes |
|---|---|---|
| Phase I-III clinical trial registration | VES 52,612.41 | Per protocol submission |
| Phase IV / post-marketing study | VES 35,000-45,000 | Varies by scope |
| Protocol amendment review | VES 15,000-25,000 | Substantial amendments |
| Annual renewal | VES 10,000-20,000 | Ongoing study maintenance |
| Import authorization (IP) | Varies | Based on product and quantity |
**Fee update note**
INHRR fees are denominated in Venezuelan bolívares (VES) and are subject to periodic adjustments. bioaccess® maintains current fee schedules and handles all payment logistics for international sponsors, converting fees to USD equivalents for budgeting purposes.
INHRR inspection process
INHRR has the authority to conduct both routine and for-cause inspections of clinical trial sites. Inspections typically focus on:
- GCP compliance verification across all study activities
- Source data verification and CRF/eCRF accuracy
- Informed consent documentation — signed, dated, correct version
- Investigational product accountability and storage conditions
- Adverse event reporting completeness and timeliness
- Essential document maintenance and Trial Master File completeness
- Qualifications and training documentation for study staff
Post-approval obligations
After receiving INHRR clinical trial authorization, sponsors and investigators have ongoing obligations:
- Annual progress reports to INHRR
- Expedited reporting of Serious Adverse Events (SAEs) and SUSARs
- Development Safety Update Reports (DSURs) as required
- Protocol amendment submissions for any substantive changes
- Final study report submission within 12 months of study completion
- Compliance with INHRR inspection requests
SACS medical device registration
For sponsors interested in market access alongside clinical research, Venezuela's medical device registration is handled by SACS (Servicio Autónomo de Contraloría Sanitaria) rather than INHRR. SACS offers an exceptionally fast ~20 business day registration timeline — the fastest in Latin America.
bioaccess® regulatory support for INHRR submissions
bioaccess® provides comprehensive INHRR regulatory support for international sponsors. As the first CRO to establish clinical trial operations in Venezuela, bioaccess® has direct experience navigating the INHRR review process.
- Pre-submission regulatory strategy and INHRR consultation
- Complete CTA package preparation and quality control
- INHRR submission and ongoing liaison during review
- Query response management and timeline optimization
- Post-authorization compliance and safety reporting
- IP import authorization through INHRR
- SACS medical device registration for market access
**Navigate INHRR with confidence**
bioaccess® has the local regulatory expertise to manage your INHRR submission efficiently. Contact us to discuss your Venezuela clinical trial strategy.
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