Aug/13 |
Standard |
Anvisa |
2 |
Resolution of the Collegiate Board - RDC no. 38, of August 12, 2013. Official Gazette of the Federal Government, section 1, p. 48, Aug 18. |
Expanded access, compassionate use, and provision of post-trial access to treatment |
May/14 |
Document |
WHO |
1 |
Regulatory system fortification for medical products. Sixty-Seventh World Health Assembly WHA 67.20. p. 41-15. |
Cooperation, collaboration, regionalization, regulatory convergence; harmonization, transparency in decision-making. |
Jul/15 |
Document |
WHO |
2 |
Emergency Use Assessment and Listing Procedure (EUAL) for candidate in vitro diagnostics (IVDs) for use in the context of a public health emergency. 2015. |
Emergency Use Assessment and Listing (EUAL). |
Jul/15 |
Document |
WHO |
2 |
Norms and legal norms: assessing new medical products in health emergencies: the EUAL procedures. Drug Information, v. 29, n. 3, 2015. |
Emergency Use Assessment and Listing (EUAL). |
xx/16 |
Document |
Anvisa |
1 |
Anvisa’s 2015 Activity Report. Brasília. 2016. |
Information sharing. |
Jan/16 |
Document |
Anvisa |
2 |
Products regulated by Anvisa for detection of Dengue, Chikungunya and Zika viruses. Communications Office, Brasília, 2016. |
Registration prioritization, priority review. |
Jan/16 |
Document |
Anvisa |
2 |
Anvisa prioritizes analysis of commercial kits to diagnose Zika, Chikungunya and Dengue. Communications Office, Brasília, 2016. |
Registration prioritization. |
Feb/16 |
Document |
WHO |
1 and 2 |
WHO to fast-track availability of diagnostics for Zika virus. Feb. 15, 2016. |
Cooperation, collaboration. Registration prioritization, priority review. |
Feb/16 |
Document |
Anvisa |
1 |
International regulatory authorities are committed to combating Zika. Communications Office, Brasília, 2016. |
Cooperation, collaboration. |
Mar/16 |
Document |
WHO |
1 and 2 |
WHO and experts prioritize vaccines, diagnostics, and innovative vector control tools for Zika R&D. 2016. |
Cooperation, regulatory convergence. Accelerated regulatory pathways. |
Mar/16 |
Document |
Anvisa |
1 |
Management report for the fiscal year 2015. Brasília, 2016. |
Cooperation, regulatory convergence, information sharing. |
Apr/16 |
Document |
Anvisa |
1 |
Anvisa joins other regulatory agencies for common actions against the Zika virus. Communications Office, Brasília, 2016. |
Information sharing. |
Apr/16 |
Document |
Anvisa |
1 |
Anvisa and FDA sign Continuous Cooperation Agreement to combat the Zika Virus. Communications Office, Brasília, 2016. |
Cooperation, information sharing. |
May/16 |
Document |
Anvisa |
1 |
Anvisa signs a confidentiality agreement with the WHO Department of Essential Medicines. Communications Office, Brasília, 2016. |
Cooperation, information sharing, reliance. |
Jun/16 |
Document |
Anvisa |
2 |
Anvisa registers new rapid test for Zika. Communications Office, Brasília, 2016. |
Registration prioritization, priority review. |
Jul/16 |
Document |
Anvisa |
1 |
Anvisa helps combat the Zika epidemic in Peru. Communications Office, Brasília, 2016. |
Cooperation, collaboration, information sharing, work sharing. |
Oct/16 |
Document |
Anvisa |
1 |
Workshop debates public health emergency scenarios. Communications Office, Brasília, 2016. |
Cooperation, collaboration, information sharing. |
Dec/16 |
Document |
Anvisa |
1 |
CEO takes stock of 2016. Communications Office, Brasília, 2016. |
Cooperation, regulatory convergence, harmonization, participation in technical forums. |
May/17 |
Document |
Anvisa |
1 |
Anvisa moderates an event at the WHO on regulatory agencies. Communications Office, Brasília, 2017. |
Cooperation, information sharing, participation in technical forums. |
Jun/17 |
Document |
Anvisa |
1 and 2 |
CEO highlights mutual support during crises. Communications Office, Brasília, 2017. |
International collaboration. Accelerated regulatory pathways. |
Jun/17 |
Document |
Anvisa |
1 |
Barbosa debates international regulatory convergence. Communications Office, Brasília, 2017. |
International collaboration, regulatory convergence. |
Aug/17 |
Document |
Anvisa |
2 |
2016 activity report. Brasília: Anvisa, 2017. |
Analysis prioritization |
Dec/17 |
Standard |
Anvisa |
2 |
Resolution of the Collegiate Board - RDC no. 204, of December 26, 2017. Official Gazette of the Federal Government, ed. 248, section 1, p. 32-89, Dec 28. |
Accelerated regulatory pathways, submission prior to registration. |
Dec/17 |
Standard |
Anvisa |
2 |
Resolution of the Collegiate Board - RDC no. 205, of December 28, 2017. Official Gazette of the Federal Government, ed. 249, v. 249, section 1, p. 28-114, Dec 29. |
Accelerated regulatory pathways, submission prior to registration. |
Aug/18 |
Document |
Anvisa |
1 and 2 |
2017 activity report Brasília. 2018. |
Regulatory convergence, harmonization, participation in technical forums. Registration prioritization. |
Aug/18 |
Document |
Anvisa |
1 |
Management report for the fiscal year 2017. Brasília: Aplan/Anvisa, 2018. |
Registration prioritization, accelerated regulatory pathways |
Aug/18 |
Document |
WHO |
2 |
WHO Emergency use assessment and listing procedures for medical products during public health emergencies. 2018. |
Cooperation, collaboration, information sharing. |
Aug/18 |
Document |
Anvisa |
1 |
First International Simulated Exercise among Regulatory Authorities. Communications Office, Brasília, 2018. |
Cooperation, collaboration, information sharing. |
Sep/18 |
Document |
Anvisa |
1 |
Medtrop: Anvisa debates public health emergencies. Communications Office, Brasília, 2018. |
Registration prioritization, accelerated regulatory pathways. |
Oct/18 |
Document |
Anvisa |
1 |
Anvisa presents Brazil’s harmonization with ICH. Communications Office, Brasília, 2018. |
Cooperation, harmonization, participation in technical forums, information sharing. |
Apr/19 |
Document |
Anvisa |
1 |
Management report for the fiscal year 2018. Brasília: Aplan/Anvisa, 2019. |
Cooperation, participation in technical forums. |
Sep/19 |
Standard |
Anvisa |
1 |
RDC no. 307, of September 27, 2019. Official Gazette of the Federal Government, section 1, p. 801, Oct 02. |
Information sharing, regionalization. |
Nov/19 |
Document |
Anvisa |
1 |
Anvisa gets a seat on the ICH Management Committee. Communications Office, Brasília, 2019. |
Harmonization, participation in technical forums. |