ANMAT Disposition 7516/2025: A Regulatory Milestone Transforming Clinical Research and Pharmacovigilance in Argentina
December 1st marked a turning point in the Argentine pharmaceutical regulatory landscape. With the entry into force of ANMAT Disposition 7516/2025, the country not only modernizes its framework for clinical pharmacology studies but also aligns itself with the most demanding global quality and safety standards.
The Adoption of ICH E6 (R3): Global Convergence
The most significant change in Disposition 7516/2025 is the adoption of the ICH E6 (R3) guideline on Good Clinical Practice (GCP). This measure comprehensively replaces previous regulations (such as Dispositions 6677/2010, 4008/2017, 9929/2019, and 2172/2025), establishing a unified and robust framework.
The implementation of ICH E6 (R3) implies a profound review of quality management systems in clinical trials, with a particular emphasis on participant protection and data quality.
Key Aspects of Disposition 7516/2025
| Key Aspect | Impact of Disposition 7516/2025 |
|---|---|
| Quality Standard | Adoption of the ICH E6 (R3) guideline, ensuring convergence with international standards. |
| Regulatory Framework | Replacement of multiple previous dispositions, simplifying and unifying regulation. |
| Process Streamlining | Decentralization of inspection and authorization, allowing the participation of provincial health authorities. |
| Access to Treatments | Facilitates early access to innovative medicines for patients with rare diseases. |
| Ethics and Safety | Reinforcement of participant protection and the ethical and scientific traceability of studies. |
The Link with Pharmacovigilance: Safety in Clinical Trials
Although Disposition 7516/2025 focuses on GCP, its impact on Pharmacovigilance is undeniable, especially in safety management during the investigation phase.
The ICH E6 (R3) guideline requires sponsors and research centers to establish rigorous quality management systems for the identification, documentation, and reporting of all adverse events, with special attention to Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
For laboratories and marketing authorization holders, this translates into the need to:
- Update Pharmacovigilance Standard Operating Procedures (SOPs) for the clinical phase, ensuring the correct implementation of ICH E6 (R3) requirements.
- Strengthen the training of clinical research and Pharmacovigilance personnel on the new safety reporting and management requirements.
- Ensure the traceability and quality of the evidence generated, from the investigation site to the final report to ANMAT.
LAMA Access: Your Strategic Partner in the New Regulatory Context
This new regulatory framework represents both a challenge and an opportunity. The correct implementation of Disposition 7516/2025 is crucial to ensure the continuity and success of clinical research programs in Argentina.
At LAMA Access, our expertise in interpreting and applying ANMAT regulations positions us as the ideal partner for your company.
Do you need to adapt your Vigilance system to the new standards?
We support laboratories and marketing authorization holders in optimizing their systems for:
- Pharmacovigilance
- Technovigilance
- Cosmetovigilance
Contact us today at info@lamaaccess.com to work together on the regulatory and operational excellence of your Vigilance system.