Argentina

DCT Feasibility Assessment Argentina The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Argentina in relation to Decentralized Clinical Trials (“DCTs”). Argentina abides by the regulations set forth by the National Administration of D...

2.1 Name of Regulatory Authority ANMAT is an application authority under the Argentine Ministry of Health (MH). Trials may also be subject to provincial regulations depending on where they are conducted.  2.2 Name of Ethics Committ...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. The investigator must submit at least the following documents: Application note indicating the...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  Preclinical and clinical trial protocol requirements are set forth in MoH Regulation No....

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)? No . However, as per the National Administration of Drugs, Foods and Medical Devices Regulation 6677/10 ,  “ the investigator shall...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. The application gathers information about the import/export shipment which includes: Name and address of clinical sponsor/investigator authoriz...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? ANMAT is open to the use of decentralized elements in a study. These will be considere...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The Data Privacy Act needs to be complied with. Further to this, according to the  National Administration of ...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? The ethics committee has the responsibility of approving the recruitment mech...

10.1 Clinical Trial with Investigational Medicinal Product Submit an application to the local ethics committee. Once approval has been gained, submit a clinical trial application to ANMAT. Upon payment of the fees, the review period commence...

Vogelius E, Millan H, Rosati F, and Varela E (2012) Multi-Jurisdictional Guide 2012 – Argentina ,  Associate of Corporate Council (ACC) Allende & Brea (June 2022) Data Protected – Argentina ,  Linklaters Dobranzanski W (27 J...

Not applicable.