1 min read

In Colombia's regulatory landscape, the standardization of data associated with pharmaceutical products is a critical component to ensure traceability, interoperability, and efficiency in health evaluations. In response to these challenges, INVIMA has been implementing the Drug Data Standard, aligned with the principles of the State's Digital Transformation Strategy and the guidelines of the Ministry of Health.

What is INVIMA's Drug Data Standard?

It is a technical tool that defines the minimum set of structured information that must be submitted for regulatory procedures related to medicines before INVIMA. Its main objective is to facilitate the review, evaluation, and monitoring of regulatory information, ensuring that all stakeholders operate with a common language and consistent data.

The standard includes key elements such as:

  • Drug identification
  • Active ingredient(s)
  • Pharmaceutical form
  • Concentration
  • Route of administration
  • Commercial presentation
  • Storage conditions

This structured model is compatible with global data harmonization initiatives such as IDMP (Identification of Medicinal Products), promoted by the WHO and other regulatory agencies.

Benefits for the pharmaceutical industry

Adopting the standard enables:

  • Greater accuracy in registration and renewal processes
  • Reduction of errors due to data inconsistencies
  • Shorter response times from INVIMA
  • Enhanced traceability throughout the product lifecycle
  • Improved data quality for pharmacovigilance activities

Practical applications and progress

INVIMA has begun requiring the use of this standard in processes such as:

  • New drug marketing authorizations
  • Renewals and amendments of existing registrations
  • Notifications of changes in ownership or representation

Additionally, the standard is progressively being integrated into INVIMA's online regulatory platform, allowing for more efficient capture, validation, and reuse of structured data.

How can Freyr drive your regulatory transformation in Colombia?

Freyr Solutions supports your transition to a more structured, precise, and compliant regulatory data model in line with INVIMA's latest requirements.

Our services include:

  • Gap analysis of existing data quality
  • Portfolio alignment with INVIMA's Drug Data Standard
  • Training internal teams on regulatory data structuring
  • Preparation of regulatory submissions compatible with the standardized model

Our approach combines technical expertise, strategic vision, and local regulatory insight, backed by a regional presence and global experience, enabling us to implement best regulatory practices and reduce approval times in an increasingly digital environment.

Transform your regulatory data management into a strategic asset to accelerate approvals, mitigate risks, and enhance your positioning before INVIMA.