Vita, represented by consultant Alessandra Rolim, attended the online meeting held on October 15, 2026, in which ANVISA’s General Management of Medicines and Biological Products (GGMED) presented to the pharmaceutical industry sector its strategy to receive eCTD 4.0 submissions with structured product data in the ISO IDMP standard (Identification of Medicinal Products). The meeting had about 390 participants, and this post brings, firsthand, a summary of what was discussed.

From reading PDFs to analyzing data

The objective presented by ANVISA is to move from an assessment based on reading PDFs to an assessment based on data, with greater speed and consistency of treatment. In this logic, the CTD (ICH M4, ANVISA Guide 24) organizes the documents, the eCTD defines the submission rules and the IDMP defines how product data should be structured. The platform contracted for the eCTD is already able to receive structured data, and what remains to be defined is the structure of that data, which is the role of the Brazilian IDMP Implementation Guide (BRIG).

IDMP and BRIG: what is being built

The IDMP brings together five ISO standards, covering medicinal product and regulatory context, pharmaceutical product, substances, pharmaceutical terms and units of measure. The model separates product, packaging, manufacturing and administration, which makes it possible, for example, to locate within minutes all products affected when a raw material supplier is subject to an international restriction.

The BRIG adapts this model to the Brazilian regulatory reality. It is in a preliminary version, not yet published, with about 250 pages, and was built on the HL7 FHIR R5 interoperability standard, already used by the Ministry of Health. According to ANVISA, compatibility with the European and Swiss implementations, considered the most advanced, was maintained, and the central message is that there is no Brazil-only IDMP, since adherence to the global standard is what ensures the international exchange of information.

Alignment with ICH and expected gains

ANVISA sees the IDMP as the likely standard to be adopted by ICH, which is also moving toward structured data, as shown by the M4Q(R2) revision and the M8 (eCTD), M11 and M16 guidelines. Among the expected gains, the Agency cited automated verification of sameness in reliance processes with other authorities, the link between global pharmacovigilance reports and the products authorized in Brazil, and the verification of manufacturers at import. The regulatory decision, however, remains human, as accountability requires.

Timeline and company preparation

The data currently sent in FP1, FP2, Word or PDF would be submitted in a structured way, in formats such as JSON or XML, which requires harmonizing terms. An ANVISA pilot with real products found about 12 different ways of describing the same excipient, and there are Brazilian particularities to be solved, such as the representation of the tarja (dispensing category band).

To build BRIG 1.0 by consensus, ANVISA proposed a working group with association representatives, which will draw up a transition roadmap, and accepted the suggestion of two representatives per entity. As for timelines, the Agency stated that the eCTD should be functional between the end of 2026 and 2027, with a pilot in 2027 and no date to become mandatory, and that the IDMP does not yet have a date, a defined supplier or an ongoing procurement process.

As the IDMP cannot be bought ready-made and will be built with the sector, Regulatory Affairs teams can start mapping how products, substances and dosage forms are currently described. Vita follows the regulator’s actions regarding these subjects and is able to support companies in the activities to be conducted.