New Codes for Evaluation of Medicines and Biologics

Posted onAuthorSerhat Demirkol

The Brazilian Health Regulatory Agency (Anvisa) has recently introduced new subject codes for the streamlined evaluation of medicines, biological products, vaccines, and Active Pharmaceutical Ingredient (API) Dossier Suitability Letters. These codes facilitate the use of assessments conducted by equivalent foreign regulatory authorities, enhancing regulatory confidence and efficiency.

Background

The creation of these subject codes aligns with the recently published Normative Instruction 289/2024, which outlines criteria for the optimized evaluation procedure based on regulatory reliance. Under this mechanism, Anvisa can accept reports, opinions, technical or legal documents from foreign regulatory bodies as part of the registration process. These documents may be decisive, auxiliary, or advisory in nature, as specified in the relevant regulatory instrument of the foreign authority.

Subject Codes for Evaluation of Medicines and Biological Products

For the optimized analysis of biological products and vaccines, the following subject codes apply:

  1. 12275 – GGBIO: Amendment for applying the optimized registration analysis procedure.
  2. 12276 – GGBIO: Amendment for applying the optimized post-registration safety and efficacy analysis.
  3. 12277 – GGBIO: Amendment for applying the optimized post-registration quality analysis.

For medicines and API Dossiers, the subject codes are as follows:

  1. 12278 – GGMED: Application of the optimized safety and efficacy analysis procedure for synthetic medicines.
  2. 12279 – GGMED: Application of the optimized quality analysis procedure for synthetic medicines.
  3. 12280 – GGMED: Application of the optimized relative bioavailability analysis procedure.
  4. 12281 – GGMED: Application of the optimized analysis procedure for Herbal Medicines, Specific Medicines, or Dynamized Medicines.
  5. 12282 – GGMED: Application of the optimized impurity qualification analysis procedure.
  6. 12283 – Cadifa: Request for the optimized analysis procedure for API Dossiers.

Recognized Equivalent Foreign Regulatory Authorities

Anvisa recognizes the following foreign regulatory authorities for reliance purposes:

  1. European Medicines Agency (EMA): Applicable for medicines, vaccines, and biological products (centralized assessment processes).
  2. Health Canada: Applicable for medicines, vaccines, and biological products.
  3. World Health Organization (WHO): Applicable for APIs, medicines, vaccines, and biological products.
  4. European Directorate for the Quality of Medicines & HealthCare (EDQM): Applicable for APIs (no need for introductory documentation).

By leveraging assessments conducted by these recognized authorities, Anvisa aims to enhance efficiency, promote global collaboration, and ensure the safety and efficacy of medicinal products and biologics.

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