Following Resolution No. 451/2020 that came into effect in February 2021, Anvisa regulates radiopharmaceuticals exempt from registration upon notification process.
The Resolution RDC No. 451, of December 16, 2020 came into effect in February 2021, and establishes the minimum requirements on the registration, notification, importation and quality control of radiopharmaceuticals. Previously, there was no possibility of radiopharmaceutical notification process.
This Resolution regulates ready-to-use radiopharmaceuticals, non-radioactive components for labeling with a radioactive component (kits) and radiopharmaceutical precursors, including eluates from radionuclide generators.
So far, Anvisa has in its portfolio of radiopharmaceuticals exempt from registration 5 products, among them: PSMA 1007 – F18; PSMA11-68Ga; DOTATE-68Ga and PIB-11C.
Requirements for Notification Process
I. There should be no radiopharmaceutical with identical API registered at Anvisa;
II. Must be marketed ready for use, in its radiolabeled form;
III. Must be produced upon prescription by a legally qualified professional, for specific patient(s);
IV. Production must not exceed 100 prescriptions per radiopharmaceutical per week, per production unit;
V. There shall be no drug product registered at Anvisa, with equivalent diagnostic or therapeutic purpose, available in the market;
VI. It must be produced in Brazil in a manufacturing unit that has a Operating License and Operating Authorization (AFE) to manufacture Drugs;
VII. It must be produced in a producing unit that proves compliance with the respective Good Manufacturing Practices;
VIII. Must be produced in a production unit duly authorized and licensed by the National Nuclear Energy Commission (CNEN); and
IX. The production unit of the radiopharmaceutical must have its own quality control laboratory duly equipped to perform the tests necessary for the release of the radiopharmaceutical.
The Notification Process
The Notification Process for Radiopharmaceuticals must be carried out by electronic petitioning, and must be instructed with the following information:
- Notification form;
- Technical justification containing:
(a) proof of the framing of the radiopharmaceutical in the criteria
foreseen in Resolution No. 451/2020;
(b) risk assessment, regarding safety and efficacy, on the benefit of
the supply of the radiopharmaceutical; and
(c) risk assessment, concerning quality, production process and
quality control of the radiopharmaceutical.
III. Certificate of Good Manufacturing Practices; and
IV. Sanitary Surveillance Inspection Fee with the respective proof of
Period for Analysis
The period for analysis of the notification process is 30 days, and the decision is not published in the Official Gazette of the Union (D.O.U.). An electronic letter is sent to the company, which may use it to certify the regularity of the product
For more information, click here to access the complete Resolution (available only in Portuguese).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.