Argentina does have a national clinical trial registry for a clinical trial disclosure and registration is mandatory. Results posting for all trials is not mandatory in the ANMAT regulation. The clinical trial registry of Argentina is the National Registry of Health Research (ReNIS), which was created by the Ministry of Health through Resolution 1480/2011.

Registries at a Glance
Registry	PHUSE Categorization	Information to be Entered By	Route of Data in Registry	Study Type	Language
ReNIS	Mandatory National Database (includes Ethics Requirement)	Competent authority	Clinical Trial Application	Interventional (Phase 1-4); Observational	Spanish
InfoSalud Mendoza	Mandatory National Database (includes Ethics Requirement)	Competent authority	Clinical Trial Application	Interventional (Phase 1-4); Observational	Spanish

Registry Updates

• July 2020: EMA Exceptional Transparency Measures - During the COVID-19 pandemic, EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation. EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines. Under this practice, the clinical trial data for COVID-19 medicines will be published on … Continue reading "July 2020: EMA Exceptional Transparency Measures"
• July 2020: EU Fine-Tunes Guidance For New Clinical Trials System – A Pink Sheet Article - The Pink Sheet article dated July 17th reported on a July 1st session at the DIA Europe 2020 Conference on “Clinical Trial Regulation: State of Play – Are We Ready?”. Judith Creba speaking on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA) addressed industry’s preparedness for the new legislation noting “We are as … Continue reading "July 2020: EU Fine-Tunes Guidance For New Clinical Trials System – A Pink Sheet Article"
• July 2020: Medical Device Regulation (MDR) Update - As per the State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR, the priority action for transparency was to issue a fact sheet on information to become publicly accessible. This Factsheet on MDR requirements for Transparency and Public Information has been published on … Continue reading "July 2020: Medical Device Regulation (MDR) Update"

References