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RDC/Anvisa
Download the legislation files by clicking on the button or searching for them:
OS_nº_103_e_104_2021_21Jun2021
RDC_506_2021_Clinical_Trials_With_Advanced_Therapy_Product_Investigational
RDC_508_2021_Good_Practice_In_Human_Cells_For_Therapeutic_Use_And_Clinical_Research
RDC RESOLUTION No. 519, OF JUNE 10, 2021
RDC RESOLUTION No. 518, OF JUNE 10, 2021
Guidance for scheduling hearings with Anvisa's Coordination of Clinical Research on Medicines and Biological Products (COPEC) (TECHNICAL NOTE No. 12/2021)
Manual for the Submission of Monitoring Reports - 1st Edition
5th Edition: MANUAL FOR SUBMITTING MODIFICATIONS, AMENDMENTS, SUSPENSIONS AND CANCELLATIONS
5th Edition (Annexes): MANUAL FOR SUBMITTING MODIFICATIONS, AMENDMENTS, SUSPENSIONS AND CANCELLATIONS
Inspection Guide No. 35/2020 - Anvisa - Research Centers
Inspection Guide No. 36/2020 - Anvisa - Sponsors and CROs
TECHNICAL NOTE NO. 14/2020/SEI/COPEC/GGMED/DIRE2/ANVISA
RDC nº 449, 15Dec2020
Circular Letter No. 4/2020-CONEP/SECNS/MS
Guidelines for conducting research and CEPS activities during the SARS-COV-2 coronavirus pandemic
RDC No. 318 - 06Nov2019 Stability Studies
RDC No. 304 - Good Distribution, Storage and Transportation Practices for Medicines.
RDC No. 214 - Gene Therapy
Advanced Therapy Product Classification/Framework Form in accordance with RDC No. 214/2018
FAEC RDC 09/2015 V4.0 Aug2018
Manual For Submission Of Changes, Amendments, Suspensions And Cancellations
RDC 172/2017 Importation of Clinical and Scientific Research - Portuguese
MS Ordinance No. 2.201 of September 14, 2011
RDC no. 102, of August 24, 2016
ANVISA Assistance Program Report
Manual for submitting modifications amendments suspensions and cancellations
Technical Note No. 118/2016 - ANVISA
Manual for the Submission of Modifications, Amendments, Suspensions and Cancellations (2nd edition)
Questions and Answers on RDC 10/2015
Quality Data Submission Manual for Investigational Products Used in Clinical Trials - Synthetic and Semisynthetic Medicinal Products (2019 - 3rd edition)
Quality Data Submission Manual for Investigational Products Used in Clinical Trials - Biological Medicinal Products (2019 - 3rd edition)