Colombian Emergency Use Authorization for Vaccines and Medicines for COVID-19, ¿How does it work?

Decree 1787 of 2020 from MoH contains the guidelines to assess chemical and biological synthesis drugs which due to its potential use in the treatment of COVID, can obtain an Emergency Use Health Authorization (ASUE in Spanish) and can be employed on a conditional and temporary basis (1 year) with the possibility of a one time renewal.

The drug candidate must undergo a Phase III clinical trial (in Colombia or another country) and provide additional support of the safety and efficacy of the drug, demonstrating a favorable benefit-risk ratio.

Drugs with ASUE are expected to continue with the conventional registration process, once complete clinical data are gathered (Decree 677/1995, Decree 1782 of 2014).

ASUE APPLICATION AND POST APPROVAL ACTIVITIES

The process includes the following stages

1.       Early dialogue (under INVIMA’s pre-established rules) to discuss the information to be submitted in the ASUE and obtain guidance from the Specialized Medicines Chamber at INVIMA.

2.       ASUE Submission Dossier with the ICH CTD structure including additional information as specified below:

  • Module 1 – Application Form and local legal requirements
  • Module 2 – Quality, safety, and efficacy overviews
  • Module 3 – Quality (CMC) Module:
  • Module 4 – Reports of non-clinical studies”:
  • Module 5 – Clinical Study Reports: Including design and results of ongoing pivotal studies.
  • Module 6 – Post-marketing information: summaries and analysis of the periodic safety reports (PBRER, PSUR, others).
  • Module 7 – Risk Management Plan.
  • Labelings (for patient and prescriber). ASUE Technical Data Sheet.
  • Updates Plan. It must contain the gradual plan and schedule for the delivery of quality, safety, and efficacy information obtained after ASUE’s issuance. Besides, it must contain the commitment to submit any data to INVIMA, as soon as they are available.
  • Emergency Use Authorizations issued by other authorities (FDA, EMA, UK) if available.

3.       Assessment of the Application by the Specialized Chamber for Medicines and Biological Products and INVIMA. The authority will have 10 business days to make their decision. In case a deficiency letter is issued, the applicant will have 10 days to respond and INVIMA another 10 days to make the final decision.

4.         Issuance of the ASUE including INVIMA’s instructions for continuous review and delivery of post-authorization data, approval of labelings (IPPs) and publication of the technical sheet of the ASUE at the INVIMA’s webpage.

5.         Importation of medicines with an ASUE following the guidelines of INVIMA’s Health Operations Department. Subsequent distribution according to criteria set by the Ministry of Health and keeping records         for traceability throughout the entire chain.

6.         Continuation of pivotal studies until completing the information of module 5 of the CTD and providing periodic updates to INVIMA of the new information generated and updated IPPs.

7.         Active and passive pharmacovigilance. Mandatory reports according to the pharmacovigilance program. PBRER or PSUR must be  delivered every 6 months.

Until 26 April 2021 the emergency authorization has been issued for 3 COVID-19 vaccines, one has obtained authorization via a differential proceeding.  In the table below there is the status of the vaccines negotiated by the Colombian government or under research in the Colombian territory.

The Government has two mechanisms for the aquisicion and entrance to the country of COVID vaccines:

  • Within the COVAX mechanism endorsed by the WHO, and
  • Through bilateral agreements with the manufacturers

It is also available a mechanism for vaccine acquisitions by private companys regulated in Resolution 507 of 2021. Already issued ASUEs must been also amended to allow the inclusion of said private companies as authorized importers.

It is worth noting that although the ASUE has been initially applied to vaccines, it is open to any other type of medicine that meets the conditions mentioned in Decree 1787.

Source:

INVIMA COVID 19 comparativo vacunas febrero 2021

Plan Nacional de Vacunación conta el COVID Ministerio de Salud https://www.minsalud.gov.co/salud/publica/Vacunacion/Paginas/Vacunacion-covid-19.aspxy

MoH statements https://www.minsalud.gov.co/Paginas/Primeras-vacunas-de-Sinovac-llegaran-el-20-de-febrero.aspx

Resoluciones INVIMA citadas.

INVIMA Statements (27 april 2021) regarding Sputnik Vaccine. @invimacolombia, 27 april 2021, G [Teewt] Video by Guillermo José Perez Blanco, Director de Medicamentos y Productos Biológicos.