Clinical Trial Data Requirements
Authorization from ANMAT is required for any Phase I, II, or III protocols. Phase IV protocols require prior authorization in certain cases. Requirements for clinical trials are outlined in Regulation 6677/10. Additionally, Resolution 1480/2011 also provides guidance on clinical trials. Resolution 1480/2011 is available here (in Spanish).
The study sponsor shall submit to the ANMAT the following documents to apply for authorization, in order:
(A) EFCA1 form completed and signed by the sponsor (Section F)
(B) proof of payment of duty
(C) composition of the Independent Data Monitoring Board (IDMB), if applicable
(D) evidence of the delegation of functions to the representative of the sponsor authenticated Hague Apostille and translated by certified translator, when applicable
(E) affidavit original sponsor of the investigational product meets the GMP requirements established for that purpose. In the case of products not fully governed by GMP should identify the aspects of production that do not meet the GMP
(F) study protocol
(G) general version of informed consent
(H) of the investigational product monograph (MPI)
(I) Notice of application for import or export of materials or samples of the study. For drugs should specify: name, dosage form, concentration and quantity. For biological samples: type. Sample and destination. For other materials: detail and quantity
(J) Copy in Spanish of investigational product label
The sponsor is required to submit the following to authorize an investigator or research center:
(A) completed and signed form EFCA2 (Section F)
(B) a copy of the provision authorizing the study
(C) summary resume, signed and dated by the investigator
(D) certified copies of professional qualifications and professional registration in the study jurisdiction and training records and / or experience in clinical research
(E) for studies of Phase II and III, a certified copy of certificate of specialization or complete residence certificate or graduate in the specialty of the disease under study
(F) original letter of commitment to comply with the study protocol (indicating the title), the Declaration of Helsinki and the Conditions of BPC-ANMAT EFC
(G) a certified copy of the study approval by a Research Ethics Committee (REC), specifying all the documents reviewed, for example, protocol, informed consent and the investigational product monograph. We will accept only an approval for a CIS for each research center
(H) dated list of members of each CIS, including name, date of birth, sex, profession or occupation, position in relation to the committee and the institution
(I) a certified copy of the study authorized by the highest authority of the host institution. Should the health jurisdiction requires the health research record, certified copy of the registration certificate of study in the jurisdiction should be submitted
(J) a certified copy of the authorization of the authority of the host institution for the study review by external REC, if appropriate
(K) enabling authenticated record current health research center
(L) specific informed consent for the center, if applicable.
All documents are to be submitted in Spanish, except for the investigational product monograph. The protocol, informed consent, and EFCA forms should be submitted in print and digital format. If there are any amendments to any documents, the original document, amended document, and a letter explaining the amendments should be submitted.
Clinical Trial Import Authorization
According to Regulation 6677/10, Application to import study materials or samples is granted by the ANMAT. For biological samples, the application must include the type and purpose.
Clinical Trial Estimated Timeline
90 working days.
In-Country Manufacturing Requirements
Regulations regarding manufacturing practices is available here (in Spanish).
Clinical trial sponsors must have an insurance policy or another form of guarantee set up in Argentina.
Clinical trial sponsors must have an insurance policy or another form of guarantee set up in Argentina. If participants are injured in the study, the sponsor is responsible for ensuring medical care.
Phase 3 Requirements (if different)
For studies of Phase II and III, a certified copy of certificate of specialization or complete residence certificate or graduate in the specialty of the disease under study. Prior to initiating a Phase III, effects on fertility must be determined.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
5 clinical trials approved from June 2012 to june 2014.
Product Registration Data Requirements
The following forms for product registration can be downloaded from here (in Spanish).
Additional information about registration requirements can be found here. This outlines requirements based on the new product's classification.
Product Registration Timelines
According to this presentation, registration time varies from 10 months to 3 years.
Post Registration Pharmacovigilance Requirements
ANMAT's guidance on pharmacovigilance is available here (in Spanish).
September 23, 2014.