Snapshot

The INVIMA Abbreviated Procedure (Article 27) pathway has been developed by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos of Colombia.

This pathway can be used where new medicines and biosimilars.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Argentina Australia Brazil Canada Chile Denmark France Germany Israel Japan Mexico Netherlands New Zealand Norway South Korea Sweden Switzerland Turkey United Kingdom United States

Procedure for the pharmacological evaluation of new medicines: The interested party must submit the corresponding application to Invima, accompanied by the required documents. The Pharmaceutical Products Review Commission will have a period of one hundred and eighty (180) working days to issue the corresponding technical concept, within which time it may request in writing the applicant to complement the information presented or to provide additional studies that will allow it to form a judgment on the quality, safety and efficacy of the new drug. If after this period no response has been given to the application for registration, the Commission shall decide on the matter at the next meeting. If the product is registered in at least two (2) reference countries and has not been rejected in any reference country, the term for the pharmacological evaluation will be thirty (30) working days. The period indicated in this article shall be interrupted until the interested party files the information requested. In practice, INVIMA takes more time than the legally established limits. The INVIMA takes approximately eight to 17 months to grant an MA for medicinal products already included in the Pharmacological Code.