Journal of International Research in Medical and Pharmaceutical Sciences

PHARMA REGULATION IN BRAZIL: A REGULATORY VIEW

Journal of International Research in Medical and Pharmaceutical Sciences, Page 26-34
DOI: 10.56557/jirmeps/2022/v17i17761

Abstract


Brazil, which has the most people of any country in South America, just overtook India to become the country with the second-largest pharmaceutical sector in the entire globe. The National Health Surveillance Agency of Brazil, also known as Agência Nacional de Vigilancia Sanitária (ANVISA), was established in 1999 with the primary goal of protecting and enhancing Brazilian public health surveillance of pharmaceutical products and services. Its acronym, ANVISA, is an acronym for the name of the agency. The Brazilian Health Surveillance Agency, also known as ANVISA and housed inside the Ministry of Health, is responsible for supplying the pharmaceutical sectors with the necessary regulatory procedures and documentation. ANVISA's mission is to achieve public legitimacy as a key component of the Brazilian Unified Health System by developing a health monitoring organisation that possesses the agility, modernity, and transparency necessary to act as a national and international benchmark. This goal will be accomplished by developing a health monitoring organisation that possesses these characteristics. ANVISA is in charge of managing the registration and licencing processes for pharmaceutical laboratories and other types of businesses involved in the production of pharmaceuticals. The purpose of this research is to acquire an in-depth comprehension of the requirements imposed by the Ministry of Health of Brazil on pharmaceuticals, biological products, medical devices, and clinical trials.

Keywords:
  • Registration
  • drugs
  • medical devices
  • clinical trial
  • ANVISA
  • regulatory requirements

How to Cite

THOYAJAKSHA, V., DEEKSHA, K. S., BALAMURALIDHARA, V., GOWRAV, M. P., & THANUSH, D. (2022). PHARMA REGULATION IN BRAZIL: A REGULATORY VIEW. Journal of International Research in Medical and Pharmaceutical Sciences, 17(1), 26-34. https://doi.org/10.56557/jirmeps/2022/v17i17761

References

The Brazilian Health Surveillance Agency ANVISA South ... / the-brazilian-health-surveillance-agency-anvisa-south.pdf / PDF4PRO [Internet]. PDF4PRO; 2022 [cited 19 May 2022].

Available:https://pdf4pro.com/amp/view/the-brazilian-health-surveillance-agency-anvisa-south-396420.html

The Brazilian Health Surveillance Agency ANVISA South ... & middot; PDF fileThe Brazilian Health Surveillance Agency ANVISA South South Cooperation: the experience of ANVISA in the Americas, - [PDF Document] [Internet]. documents.pub; 2022 [cited 19 May 2022].

Available:https://documents.pub/document/the-brazilian-health-surveillance-agency-anvisa-south-wwwwhointmedicinesareasqualitysafetyregulationlegislationpdf.html

Brazilian Health Regulatory Agency (Anvisa) [Internet]. Agência Nacional de Vigilância Sanitária - Anvisa. 2022 [cited 19 May 2022].

Available:https://www.gov.br/anvisa/pt-br/english

Huynh-Ba K, Beumer Sassi A. ANVISA: An introduction to a new regulatory agency with many challenges. AAPS Open. 2018;4(1)

Available:https://aapsopen.springeropen.com/articles/10.1186/s41120-018-0029-x

Administrativo [Internet]. Agência Nacional de Vigilância Sanitária – Anvisa; 2022 [cited 19 May 2022].

Available:https://www.gov.br/anvisa/pt-br/setorregulado/administrativo

Odhaib K, Alallawee M, AL-Mousawi Z. Al-Anbar Journal of Veterinary Sciences. 2021;14(1).

Available:https://www.anbarjvs.edu.iq/wp-content/uploads/2021/06/1.pdf.

Available:https://uploads.strikinglycdn.com/files/605820ca-77aa-4a45-89a6-4408b5e507af/62567662221.pdf

Who.int. Guidelines. [online]; 2022.

Available: [Accessed 19 May 2022].

Huynh-Ba K, Beumer Sassi A. ANVISA: An introduction to a new regulatory agency with many challenges. AAPS Open. 2018;4(1).

Geyer A, Sousa V, Silveira D. Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections. Plos One. 2018;13(8): p.e0202084.

Carmo A, Piras S, Rocha, Gratieri T. Main reasons for registration application refusal of generic and similar pharmaceutical drug products by the Brazilian Health Regulatory Agency (ANVISA). BioMed Research International. 2017:1-10.

Ca.practicallaw.thomsonreuters.com. 2022. Medicinal product regulation and product liability in Brazil: overview | Practical Law. [online]

Available: [Accessed 19 May 2022].

En.wikipedia.org. 2022. Constitution of Brazil - Wikipedia. [online]

Available: [Accessed 19 May 2022].

Oas.org. 2022. [online]

Available: [Accessed 19 May 2022].

Histecon.fas.harvard.edu. 2022. Health Care as a Human Right: Reflections on Brazil's 1988 Constitution during a Pandemic. [online]

Available: [Accessed 19 May 2022].

Ca.practicallaw.thomsonreuters.com. 2022. Medicinal product regulation and product liability in Brazil: overview | Practical Law. [online]

Available: [Accessed 19 May 2022].

Ibanet.org. 2022. Regulatory responses to health emergencies and product shortages during the Covid-19 pandemic in Brazil. [online].

Available: [Accessed 19 May 2022].

Practiceguides.chambers.com. 2022. | Global Practice Guides | Chambers and Partners. [online].

Available: [Accessed 19 May 2022].

Available:https://static1.squarespace.com/static/58d0113a3e00bef537b02b70/t/5e6bde8da8232e06276e0e8f/1584127633065/0700_ANVISA_rev.pdf

Clinregs.niaid.nih.gov. 2022. Clinical Research Regulation For Brazil | ClinRegs. [online].

Available: [Accessed 19 May 2022].

IJARKE Business & Management Journal, 2019.

Available:https://storage.googleapis.com/wzukusers/user-34065638/documents/5cdc55a83662aHOFZKLa/09-IBMJ%20Vol1%20Issue4%2009.pdf. 1(4).

Agência Nacional de Vigilância Sanitária - Anvisa. 2022. Página inicial. [online].

Available: [Accessed 20 May 2022].
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