REGULATORY TECHNICALITIES FOR DRUG PRODUCT REGISTRATION IN BRAZIL

  • Mohak Vaishnav Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India) 2Torrent Pharmaceutical Limited, Ahmedabad (India)
  • Charmy Kothari Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India)
  • Manan Shah Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India)

Abstract

Brazilians are demanding better healthcare and modern medicines, presenting significant opportunities for foreign
investment. In Brazil, medicinal product registration is an extensive process. To do business in Brazil is not without
its challenges. Accessing the Brazilian healthcare market can be a major headache for many medium and small
companies without the resources and market knowledge to handle this highly regulated, technical, fragmented and
sometimes corrupt process. The Active Pharmaceutical Ingredient and excipients should be informed with their DCB
(Common Brazilian Denomination) number and administration, specifications, leaflets/labels, precautions, and
relevant information regarding the drug products must be submitted in Portuguese language in a dossier. The
registration process for medicine takes more than a year. In Latin America, Brazil, Argentina, and Chile are countries
which provide encouragement for generic product registration by discounting the registration fees for generics.
Regardless of the challenges and qualms, Brazil’s diverse population of nearly 200 million people, their geographic
location in America Latina and off course its emerging economy have proven to be enticing and promising as a
profitable market for many drug makers.
 

Keywords: DRA, Brazil, South America, Drug Registration, ROW, ANVISA, Generic Drug.

Downloads

Download data is not yet available.

Author Biographies

Mohak Vaishnav, Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India) 2Torrent Pharmaceutical Limited, Ahmedabad (India)

1Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India)
2Torrent Pharmaceutical Limited, Ahmedabad (India)

Charmy Kothari, Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India)

Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India)

Manan Shah, Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India)

Dept. of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad (India)

References

1. Candex do Brasil Ltda. [Internet]. Brazil [cited 2017
Nov 15]. Available from:
http://www.candex.us/download/invest_sao_paulo.pdf
2. Rocha M de M. Drug registration in Brazil: Challenge
or Opportunity ? Regul Focus. 2013 Mar;1-3.
3. Avoid losing time and money registering products
with ANVISA in Brazil. [Internet]. Brazil [cited 2017
Nov 15]. Available from:
http://www.candex.us/english/product-regs.html
4. Drug Registration in Brazil - Chronicle Specials
[Internet]. Brazil :2005 [cited 2017 Nov 15]. Available
from:
http://www.pharmabiz.com/article/detnews.asp?article
id=28834§ionid=50
5. Cerqueira MR. The Brazilian Health Surveillance
Agency ANVISA South South Cooperation: the
experience of ANVISA in the Americas, Africa and
Asia. [Internet]. Brazil:WHO [cited 2017 Nov 15].
Available from:
http://www.who.int/medicines/areas/quality_safety/reg
ulation_legislation/WA_1.pdf
6. Handoo S, Arora V, Khera D, Nandi PK, Sahu SK. A
comprehensive study on regulatory requirements for
development and filing of generic drugs globally. Int J
Pharm Investig [Internet]. 2012 Jul [cited 2017 Nov
15]; 2(3):99-105. Available from Pubmed:
http://www.ncbi.nlm.nih.gov/pubmed/23373001
7. Resolution - RDC no 136 of 29 May 2003 [Internet].
[cited 2017 Nov 15]. Available from:
http://www.scentryphar.com/legislation/res136.htm
8. Assessment. USCO of T. Drug Labeling in
Developing Countries. [Internet]. 1993 [cited 2017
Nov 15]. Available from:
https://digital.library.unt.edu/ark:/67531/metadc40052/
9. Gotecha A. Anvisa guidelines [Internet]. ANVISA;
2013 [cited 2017 Nov 15]. Available from:
https://www.slideshare.net/agotecha/anvisa-gudelines
10. Brazil Regulatory Drug Approval Process Brazil
Drug Funding / Reimbursement Approval Process;
2013.
Statistics
696 Views | 1603 Downloads
How to Cite
Vaishnav, M., C. Kothari, and M. Shah. “REGULATORY TECHNICALITIES FOR DRUG PRODUCT REGISTRATION IN BRAZIL”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 4, Dec. 2017, pp. 18-25, doi:10.22270/ijdra.v5i4.206.