Favorable Regulatory Environment
- Strong Regulatory Framework: Argentina has clear and detailed clinical research regulations and is GCP compliant. Since June 2024, Argentina acquired the status of Regulatory Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Shorter Approval Timelines: Argentina's National Administration of Medicines, Food and Medical Technology (ANMAT) has streamlined and modernized its regulatory process, leading to faster approval times for clinical trials compared to some other regions. Protocol approval time has been significantly reduced, from 137 in 2017 to 65 days in 2022. This translates to quicker study initiation and potentially faster drug development timelines.
- Accredited Ethics Committees: Ethics Committees are accredited regularly and perform active oversight of the studies they approved.
Favorable Time Zones
Argentina's time zone overlaps with North America and Europe facilitating communication and collaboration between research teams.
Cost-Effective
Conducting trials in Argentina is often more cost-effective compared to North America and Europe.
Strong Scientific Infrastructure
- High-Quality Medical Professionals: Argentina boasts a well-educated and experienced pool of medical professionals, including doctors, nurses, and researchers. This ensures access to qualified personnel for conducting clinical trials according to international standards, since the country´s clinical research regulations require mandatory GCP training and experience.
- Diverse Therapeutic Areas: Clinical studies conducted in Argentina have diversified enormously. Currently, some of the most important therapeutic areas are oncology, immunology, infectious diseases, respiratory diseases, cardiovascular diseases, ophthalmology, metabolic diseases, digestive and genitourinary diseases, etc.
- Advanced Medical Facilities: Many hospitals and research centers in Argentina are equipped with advanced technology and infrastructure to support clinical research activities. Research can be performed in both public and private institutions.
Patient Population
- Diverse and Treatment-Naive Population: Argentina offers a large and ethnically diverse population, providing access to a wider range of potential trial participants. Additionally, this population might be less exposed to prior treatments compared to some regions, making them ideal candidates for certain studies.
- High Patient Recruitment Rates: Argentina has a history of high patient recruitment rates for clinical trials, due to factors like a strong public healthcare system and patient willingness to participate in research.
- High Patient Retention Rates and Adherence to study protocols: strong physician-patient relationships contribute to the integrity of the clinical trial data.
