Chile's ISP Cuts Biological Drug Approval Times by 83.8%

Chile’s ISP Cuts Biological Drug Approval Times by 83.8%

October 28, 2026 Dr. Michael Lee – Health Editor Health

Regulatory Trust Cuts Biologic Drug Review Times in Chile

“Nuestro objetivo principal es la salud pública del país, colaborando a que los pacientes puedan tener un acceso oportuno a los tratamientos,” said José Crisóstomo, head of the Biological Product Registration section at the Instituto de Salud Pública (ISP). The ISP announced on Wednesday that a new evaluation system has reduced the authorization timeline for biological pharmaceutical products by 83.8%, dropping approval times from more than two years to just over four months.

    Key Clinical Takeaways:

  • Biological drug review times dropped from 829 days down to an average of 134 days using a new reliance mechanism.
  • Approximately 80% of the pharmaceuticals approved through this expedited procedure target oncological conditions, including ovarian cancer and triple-negative breast cancer.
  • The ISP utilizes scientific evaluations previously conducted by the European Medicines Agency (EMA) to avoid duplicating technical reviews while retaining final national decision-making authority.

Transition From Conventional Registration to Reliance Mechanisms

Until now, the conventional sanitary registration procedure for these complex medical products required a reference time of 829 days, or approximately two years and three months, according to data released by the Departamento Agencia Nacional de Medicamentos (ANAMED). The newly implemented regulatory confidence mechanism successfully slashed that duration to an average of 134 days.

José Crisóstomo explained that the agency initially launched a pilot project that brought processing times down from 829 days to 277 days before refining the protocol further to reach the current 134-day average. The initiative aligns directly with broader efforts by the Ministry of Health to address national demands for timely oncological care.

ISP reducirá los tiempos de aprobación de medicamentos

Oncological Treatments and Biosimilar Integration

Roughly 80% of the products cleared through this streamlined pathway consist of cancer treatments, encompassing specific regimens for ovarian cancer and triple-negative breast cancer.

Beyond innovative oncology drugs, the authorizations cover biosimilar products—biological items highly similar to previously approved therapeutics that hold the potential to decrease financial costs for the state. By avoiding redundant administrative and scientific evaluations, the agency concentrates its technical resources on final national determinations.

Chilean Agency Expands Reliance on International Health Authorities

The regulatory confidence framework uses evaluations already executed by internationally recognized health authorities. In this implementation phase, the Chilean agency utilized assessments performed by the European Medicines Agency (EMA) as its primary reference point.

The World Health Organization (OMS) endorses regulatory reliance as an effective tool to enhance administrative efficiency and optimize technical resource allocation. Following the outcomes observed during the rollout, the ISP announced plans to incorporate additional international reference agencies and deepen cooperative ties with regional regulatory bodies.

Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.

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