Snapshot

The Procedure for Pharmacological and Pharmaceutical Evaluations of Biological Drugs in the Sanitary Registration Process (Decreee 1782 de 2014) pathway has been developed by the of Colombia.

This pathway can be used where biological medicines.

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 EU-EMA France Germany Israel Japan Mexico Netherlands New Zealand Norway South Korea Sweden Switzerland Turkey United Kingdom United States

To obtain the sanitary registration of biological medicines, the approval of pharmacological, pharmaceutical and legal evaluations must be obtained. Pharmacological evaluation is the exclusive function of the Specialized Chamber. Invima will continue with the sanitary registration process, only if the Specialized Chamber issues a favorable opinion on the pharmacological evaluation. Once the Specialized Chamber approves the pharmacological evaluation, Invima will evaluate the pharmaceutical and legal information provided by the applicant and will decide whether or not to grant the sanitary registration within three (3) months, counted from the approval of the pharmacological evaluation. In the event that it considers that the information is insufficient, it will require additional information only once. The applicant must submit it within a maximum period of sixty (60) business days. The expiry of the period will be understood as withdrawal of the application. Once the complementary information has been received, the Institute will issue a concept on the sanitary registration within a maximum period of three (3) months, counted from the filing of the complementary information.