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 medicine

Brazil · Brazilian Health Regulatory Agency · New drugs

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

Review target

Not published

Legal time limit

365 days

law

Steps

14 requirements

Application fee

R$157,416

Fee table in force when checked (2026-10-03)

What is the Registration of a new medicine in Brazil?

Full registration for a synthetic or semisynthetic medicine with a new molecule, meaning a new active ingredient or an analog not yet registered in Brazil. Anvisa reviews quality, safety and efficacy before the medicine can be sold. A medicine whose active ingredient is new in Brazil. A product that can be classed as a generic or similar cannot be filed as new.

How much does the Registration of a new medicine cost?

The registration fee, new medicine is R$157,416 for Fee table in force when checked (2026-10-03). A reduced fee of R$15,742 applies in some cases (Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 7,870.80).

What are the steps of the Registration of a new medicine?

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 (Art. 12, Art. 17-A, Art. 18); Anvisa RDC 948/2024; Anvisa RDC 753/2022

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.

Approvals per year, full application, new active substance in Brazil

From the official approvals data of this market, all products of this pathway type and segment

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
Registration fee, new medicineApplication · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 7,870.80.	R$157,416reduced R$15,742

Fee

Amount

Registration fee, new medicineApplication · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 7,870.80.

R$157,416reduced R$15,742

Rule changes

Medicine registration tied to GMP certification; foreign registration proof removed from the lawIn force, June 29, 2026, effective June 29, 2026

Other routes in Brazil: Registration of an innovative medicine, Registration of a generic medicine, Registration of a similar medicine, Non-prescription status (MIP) for a registered medicine, 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), Registration of a class III or IV medical device. 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 (28 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Clinical data

Clinical trialsClinical trials with scientifically supported conclusions on safety and efficacy, plus a context of the disease in Brazil and an integrated benefit-risk assessment. Data come from the full development route (studies by or for the applicant) or the abbreviated route (part of the evidence from studies not run by the applicant, linked by bridging studies).

Nonclinical data

Nonclinical studiesNonclinical studies that show the pharmacological and toxicological properties.

Quality and manufacturing

Quality data for the active ingredient and finished productDevelopment, manufacturing process, characterization, quality control, packaging and stability for the active ingredient and the finished product. Stability studies use 3 batches. Registration requires a valid active ingredient dossier letter (CADIFA) and GMP certification of the active ingredient maker.
Quality control by the importer(in some cases)Companies that import the medicine must present quality control methods and results performed by the importer.

Risk management

Risk management planA risk management plan is part of the dossier.

Other

Benefit-risk report if sold abroad(in some cases)If the medicine is already sold in other countries, an updated periodic benefit-risk report is filed with the application.
Devices packed with the medicine(in some cases)Accessories that dose or deliver the medicine and are sold inside the medicine pack are described in the medicine dossier, with their material and specifications.
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.

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.

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 medicine

What is the Registration of a new medicine in Brazil?

How much does the Registration of a new medicine cost?

What are the steps of the Registration of a new medicine?

How the pathway works

Timeline with clock stops

Approvals per year, full application, new active substance in Brazil

Steps

Official time targets

Fees

Rule changes

Requirements

Clinical data

Nonclinical data

Quality and manufacturing

Risk management

Other

Local presence

Inspection

Language

After approval