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Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Registration of an advanced therapy product

Brazil · Brazilian Health Regulatory Agency · Cell and gene therapy

Full application, new active substanceHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

365 days

regulation

Steps

10 requirements

Application fee

What is the Registration of an advanced therapy product in Brazil?

Advanced therapy products are a special category of new medicines: advanced cell therapy, tissue engineered products and gene therapy. Class I covers minimally manipulated cells used for a different function; class II covers extensively manipulated cells, tissue engineering and gene therapy. The first registration lasts 5 years. Cell, tissue engineered and gene therapy products intended for regular marketing in Brazil.

What are the steps of the Registration of an advanced therapy product?

1. File the registration petition; 2. Technical review (365 days); 3. Technical requirements (clock stopped); 4. Decision published.

Outcome: Registration valid for 5 years, renewable after a benefit-risk review; later renewals give 10 years. Valid for 5 years.

Legal basis: Lei 6.360/1976 (Art. 17-A); Anvisa RDC 505/2021; Anvisa RDC 948/2024

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 365 days end to end with the official step targets. Targets, not actual times.

Steps

In order, with the official target for each step

1. File the registration petitionThe company states whether the product is class I (minimally manipulated cells with a different function) or class II (extensively manipulated cells, tissue engineered products and gene therapy) and pays the fee.
2. Technical review365 daysThe agency must decide within 365 days for ordinary requests and 120 days for priority requests. It may extend once by up to one third.
3. Technical requirements (clock stopped)clock stopped, only in some casesA requirement from the agency suspends the deadline until it is answered.
4. Decision publishedThe decision is published in the Official Gazette.

Requirements

What the applicant must provide or meet

Quality and manufacturing

Quality dossier (class II)(in some cases)Class II products need a quality dossier on starting materials, raw materials, the active component, the manufacturing steps, stability and storage.

Official time targets

Targets, not actual review times

Legal time limitregulation. Official maximum time for the agency decision. It is a target in the rules, not an observed review time. Time the applicant spends answering questions is not counted.

365 days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in Brazil: Advanced therapy registration with additional efficacy data to follow, Advanced therapy for an individual patient without registration. See all routes on the Brazil page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Nonclinical data

Nonclinical studiesStudies of therapeutic effect and dose, interaction with tissues, viability and distribution, toxicity, immunogenicity and tumorigenic potential. For gene therapy, genome integration studies.

Clinical data

Clinical studiesSafety studies on biodistribution, engraftment, ectopic grafts, oncogenic transformation and cell line stability, and clinical efficacy studies, with a plan for long-term efficacy.

Local presence

Brazilian company with an operating authorizationThe applicant must be a company in Brazil with an Anvisa operating authorization (AFE): to manufacture, when the medicine is made in Brazil, or to import, when it is made abroad. The applicant becomes the registration holder.

Inspection

Good manufacturing practice certificateEach manufacturing site needs a valid Anvisa GMP certificate, or a pending request for one. If only a request exists, the registration decision waits until the certificate decision is made. The law now ties medicine registration to proof of GMP certification for both domestic and foreign manufacture.

Other

Inspection fee paid before filingThe Health Surveillance Inspection Fee (TFVS) must be paid when the petition is filed.
Dossier format: CTD is allowed(optional)The technical dossier can be organized in the Common Technical Document (CTD) format. Where national rules are missing or incomplete, companies may follow ICH or WHO guidelines.

Language

Translations(in some cases)Certificates and other declarations in a foreign language need a sworn translation, except documents in English or Spanish.

After approval

PharmacovigilanceThe holder must monitor adverse events under good pharmacovigilance practice. Serious adverse events in Brazil must be reported within 15 calendar days, urgent safety issues within 72 hours, and the holder must prepare periodic benefit-risk reports.
Registration lasts 10 yearsMedicine registration is valid for 10 years. Renewal needs proof that the medicine was sold during at least the last two thirds of the validity period.