According to information from Anvisa, the import of products for advanced therapies now belongs to the pilot project of petitioning the Single Foreign Trade Portal, through the application in the Import Licenses, Permissions, Certificates and Other Documents (LPCO) module.
As of September 21 this year, with the inclusion in the pilot project, the consent to import advanced therapy products for commercial or industrial purposes or for clinical research requested will have the possibility of being submitted through the electronic petition system called Requests, from the LPCO registration, of the Advanced Therapies model, on the Siscomex Portal.
The pilot project will cover the following subjects:
90291 – Consent to Import up to 10 items for advanced therapy products, by legal entity, for industrial or commercial purposes.
90292 – Consent to import advanced therapy products under clinical research for petition.
How can you find guidance about this new procedure?
Anticipating the demand, Anvisa has already made available a systematic booklet with all the guidelines on the procedure for companies in the regulated sector. By clicking on the link, you will be able to find the latest version of the Booklet: Import Petition through LPCO – Pilot Project.
According to the publication, the Federal Revenue Service of Brazil (RFB) and the consenting bodies must migrate their import process to the Single Foreign Trade Portal, which should be used as the only window for requests to be made and payments made to all public agencies involved in the import process, as in the case of Anvisa with regard to products subject to sanitary surveillance.
What are advanced therapy products?
Advanced therapy products are products of biological origin obtained from human cells and tissues that have been manufactured and used for therapeutic purposes; or products that are formed by recombinant nucleic acids for the purpose of repairing, regulating, adding, deleting or replacing a genetic sequence or modifying the expression of a gene.
In short, advanced therapies belong to a new therapeutic class that encompasses advanced cell therapy, tissue-engineering products and gene therapy. Products in this class hold a strong therapeutic promise for diseases that do not have medical alternatives available or are highly complex, but they are still a challenge for the development of control mechanisms that guarantee their safety, quality and efficacy.
In Europe and the US, there are already records of advanced therapy products. We can mention as a highlight the culture of cells present in the patient’s own cartilage tissue, indicated to repair cartilage defects caused by trauma. There are also epithelial cells from the patient’s own cornea as well, cultured in fibrin matrix, to repair corneal damage; and autologous T cells, genetically engineered to treat patients with lymphoblastic leukemia.
Currently, in Brazil, Anvisa is based on RDC 214/2018, RDC 260/2018, and RDC 338/2020, which provides for the registration of this type of product. For more information on the subject, access Advanced Therapies on the Anvisa portal; and if you need regulatory services, contact Licempre.