On August 14, 2026, Brazil’s Health Regulatory Agency (ANVISA) released the new Good Manufacturing Practice (GMP) Certification Petition Form for Advanced Therapy Medicinal Products (ATMPs), now mandatory for all applications, for both initial certification or certification renewal, filed by domestic and international companies. The form is available on the Agency’s advanced therapy application forms page.

A single updated form for two certification scopes

Until now, filing for a GMP Certification for ATMPs required companies to organize information for two distinct manufacturing scopes separately: the active component — corresponding to the Active Pharmaceutical Ingredient (API) — and the ATMP’s manufacturing line. The new form consolidates both scopes into a single template, standardizing how this information must be presented to ANVISA for assessment.

The document checklist was also revised to incorporate fields and information already used in medicinal product GMP certification, while preserving the technical and regulatory particularities specific to ATMPs. 

The form also includes specific annexes for describing information about the ATMPs, detailing the manufacturing chain, among others. When completing the form, companies must indicate the class of ATMP covered by the application — in vivo or ex vivo gene therapy, advanced cell therapy, tissue-engineered product, or combined product.

Simplified subject codes

Alongside the new form, ANVISA reduced the number of subject codes used for ATMP GMP certification aplications. For initial certification, only two remain:

• 11821 – Advanced therapy product – GMP Certification of Active Component;
• 11822 – Advanced therapy product – GMP Certification of Sterile Products.

The same logic applies to renewals, also narrowed down to two codes:

• 11836 – Advanced therapy product – GMP Certification Renewal of Active Component;
• 11837 – Advanced therapy product – GMP Certification Renewal of Sterile Products.

Selecting the correct code depends on the scope to be filed by the company and must follow the descriptions currently in effect in ANVISA’s application system. According to the Agency, the change is meant to reduce classification doubts at filing and make the screening and routing of applications for technical review more efficient.

What changes in practice for companies

Through this standardization, ANVISA expects to give companies greater clarity on the information required to accompany GMP certification applications, improve the quality and completeness of the documentation submitted, and reduce the need for deficiency letters, gaining predictability for both domestic and foreign manufacturers seeking to operate in Brazil’s advanced therapy market.