Regulatory Reliance in Chile: A Step Forward in the Evaluation of Biological Medicines
Regulatory Reliance in Chile: A Step Forward in the Evaluation of Biological Medicines
The Institute of Public Health of Chile (ISP) has implemented a regulatory reliance
mechanism for granting health registrations for biological pharmaceutical products. This
procedure, formalized through Exempt Resolution No. E679/25 on January 27, 2025, allows
the National Medicines Agency (ANAMED) to use assessments from other high-standard
regulatory agencies to optimize the approval process.
What is Regulatory Reliance?
Regulatory reliance is a strategy recommended by the World Health Organization (WHO),
based on aligning local regulations with international standards. This mechanism enables
national health authorities to rely on evaluations conducted by other recognized
regulatory agencies, reducing duplication of efforts, optimizing resources, and
accelerating decision-making.
Application Procedure in Chile
1. Application Admissibility:
o The health registration request must be admitted within 10 business days
from the receipt of the dossier.
2. Product Evaluation:
o To qualify for regulatory reliance, a biological product must have been approved by at least two of the following high-surveillance regulatory agencies:
o European Medicines Agency (EMA)
o U.S. Food and Drug Administration (FDA, USA)
o Medicines & Health Products Regulatory Agency (MHRA, UK)
o Therapeutic Goods Administration (TGA, Australia)
o Pharmaceutical and Medical Devices Agency (PMDA, Japan)
o If the product has been rejected for health reasons by any of these agencies, regulatory reliance will not be applicable.
3. Documentation Requirements:
o Official approval letter issued by the regulatory agencies.
o Products authorized under conditional, emergency, or other provisional approvals will not be accepted.
o If the evaluation report and the question-and-answer document from one of the reference agencies are submitted, the evaluation will be shortened, and only Module 2 of the dossier will be reviewed.
4. Registration and Conditions:
o If all requirements are met, ISP will register the product under the same conditions approved by the high-surveillance agencies, including therapeutic indications, presentation, potency, and usage instructions.
Conclusion
The implementation of regulatory reliance in Chile represents a significant advancement in the efficiency of biological medicine evaluation. This mechanism not only speeds up approval
times but also reinforces confidence in the regulatory process, ensuring the safety, quality, and efficacy of products in the Chilean market.
At SCR Consulting, we provide expert advisory services to facilitate regulatory compliance and optimize processes in pharmacovigilance and health registrations, helping companies efficiently navigate national and international regulatory frameworks.