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 a new biological product (individual development route)

Brazil · Brazilian Health Regulatory Agency · Biologics

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

Review target

Not published

Legal time limit

365 days

law

Steps

12 requirements

Application fee

What is the Registration of a new biological product (individual development route) in Brazil?

Registration of a biological medicine, including vaccines, hyperimmune sera, blood products, biotech medicines and monoclonal antibodies. A product with a molecule not yet registered in Brazil, or one developed alone, needs a complete dossier with phase I, II and III clinical data. Vaccines and other biological medicines that are not filed as biosimilars through the comparability route.

What are the steps of the Registration of a new biological product (individual development route)?

1. Optional pre-submission guidance; 2. File the registration petition; 3. Technical review (365 days); 4. Technical requirements (clock stopped); 5. Decision published; 6. Public assessment report.

Outcome: Registration published in the Official Gazette, valid for 10 years. Valid for 10 years.

Legal basis: Lei 6.360/1976; Anvisa RDC 55/2010; 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. Optional pre-submission guidanceonly in some casesBefore filing, the agency can give guidance through protocol reviews, meetings or its service channels. This guidance is not binding.
2. File the registration petitionThe company files the dossier electronically and pays the inspection fee.
3. Technical review365 daysThe agency reviews quality, safety and efficacy. The legal maximum for an ordinary registration decision is 365 days from filing. The agency may extend it once by up to one third.
4. Technical requirements (clock stopped)clock stopped, only in some casesQuestions are sent in one consolidated request. The clock stops until the company answers.
5. Decision publishedThe decision is published in the Official Gazette (Diário Oficial da União).
6. Public assessment reportAfter the decision, the agency publishes a public assessment report with confidential data removed.

Official time targets

Targets, not actual review times

Legal time limitlaw. 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: Biosimilar registration (comparability route), Priority review of a registration petition, Special procedure for new medicines for rare diseases, Registration under a commitment term, Optimized analysis using an equivalent foreign authority, Good manufacturing practice certification (CBPF). 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 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Clinical data

Complete development dataTotal data on development, production, quality control and nonclinical and clinical studies. A complete dossier includes phase I, II and III clinical studies.
Immunogenicity study reportAn immunogenicity study report is required for every biological product.

Risk management

Pharmacovigilance and risk minimization plansA pharmacovigilance plan and a risk minimization plan are filed with the application.

Inspection

All manufacturers listed and GMP certifiedThe company lists every manufacturer of the active substance, bulk, filled and finished product, diluent, adjuvant and the batch release site. All must comply with GMP and hold an Anvisa GMP certificate.
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

No extrapolation of indicationsSafety and efficacy data cannot be extrapolated to other indications for products registered by the individual route.
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.

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.

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.

Registration of a new biological product (individual development route)

What is the Registration of a new biological product (individual development route) in Brazil?

What are the steps of the Registration of a new biological product (individual development route)?

How the pathway works

Timeline with clock stops

Steps

Official time targets

Fees

Requirements

Clinical data

Risk management

Inspection

Other

Local presence

Language

After approval