  
  
G/TBT/N/BRA/1120  
18 January 2021  
(21-0548) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  BRAZIL   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Brazilian Health Regulatory Agency (ANVISA)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
HS Code(s): advanced therapy medicinal products  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 453, 17 December 2020. (2 page(s), in Portuguese)  
6. Descr iption of content:  This resolution changes the Resolution – RDC number 260, 
21 December 2018, which establishes the technical requirements for the execution of 
clinical trials with advanced therapy medicinal products in Brazil and provides other 
measures.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Because of the pandemic of the new coronavirus (Sars -Cov-2), some 
Researchers in Brazil and elsewhere have been testing treatments using advanced cell 
therapies in seri ous situations of the disease, with reports of improvement for some cases. 
Thus sponsors have been submitting to the Agency clinical studies dossiers with 
invesgatory products and the Agency has fulfilled its role promoting efficient and timely 
evaluation,  with the necessary priority that requires the emergency situation. In this case, 
considering the innovative proposals in the Covid-19, there is a need for an efficient 
evaluation of Anvisa prior to the clinical trials in Brazil quickly, focusing on safety , quality 
and the search for robust efficacy results. Among advanced therapy products, a specific 
type called by the RDC 260/2018 as Class I, defines products that have not been 
substantially handled but which promote innovation in its clinical use. In com pliance with 
the situation of Covid -19, it is necessary to improve the classification and standard text 
to better understand the evaluation flow of these Class I products by the Agency. In 
addition, the proposed modifications will safeguard Anvisa and soci ety in the face of other 
similar situations and contexts of prioritization and evaluation of investigative products in 
the emergency context, as well as improvement of the regulatory text. The amendment 
to the text will provide clarity of Anvisa's workflow  and will be based on the harmonization G/TBT/N/BRA/1120  
 
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  of the Special communication (EC) concept that will apply to all types of products (Class 
I and Class II) and establishment of a 30 -day period for the Agency's analysis for Class I 
products, taking into account the e mergency involved in the Pandemic scenario, as well 
as other involving clinical trials with Class I advanced therapy products; Protection of 
human health or safety  
8. Relevant documents:  1) Brazilian Official Gazette 245 on 23 December 2020, section  1, 
page 123; 2) RDC 260, 21 December 2018 ; 3) Justification for the resolution draft  
https://www.in.gov.br/web/dou/ -/resolucao -de-diretoria -colegiada -rdc-n-453-de-17-de-
dezembro -de-2020-295783509  
http://antigo.anvisa.gov.br/documents/10181/3428326/RDC_260_2018_COMP.pdf/199
94556 -1ed3-4bb4-b3dd-37e66d354ae2  
9. Proposed date  of adoption:  23 December 2020  
Proposed date of entry into force:  23 December 2020  
10. Final date for comments:  Not applied.  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://antigo.anvisa.gov.br/documents/10181/6164660/RDC_453_2020_.pdf/8c2f0043 -
942c-42cf-8751-39723140b371  
 