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The Ministry of Health circulated the draft decree that establishes the sanitary conditions and the procedure for granting licenses (authorization) for emergency use of vaccines, drugs and other products intended for the diagnosis and treatment of covid-19.
Said project, which is subject to observations until December 24, defines for the first time the requirements of a possible vaccine and includes its scope of application, which not only covers laboratories, but also importers, distributors, pharmaceutical managers, EPS and the National Institute for Food and Drug Surveillance (Invima), among others.
In the same sense, it also establishes the conditions for a vaccine to be used in emergency, starting with the formal request by the interested parties and following all the information that from the investigative level confirms the safety and efficacy of the products. and the approval of other health agencies in the world.
(Also read: Five keys about the arrival of the vaccine against covid-19 in Colombia)
“If the results of the large-scale study are not available, Invima will consider whether the preponderance of the evidence from preclinical and early human studies, and any other information that it is aware of (…). In such cases, health authorization for emergency use may proceed as long as there are ongoing trials that are expected to provide clinical validation “says the document, opening the door for vaccine projects that have not completed their late-phase trials to be approved.
Similarly, it establishes the conditions that applicants must meet in terms of rigor, transparency, operational capacity and the deadlines for these purposes.
In essence, the document sets 20 business days for Invima to deny or approve the use of these vaccines and additional days for the delivery of information that is required.
The licenses will be granted for the duration of the emergency, says the draft decree, without this hampering the formal registration if the products complete the investigations and studies.
(You may be interested: This is how vaccination will be for Colombians)
Those who receive licenses must complete the studies in progress and those that are requested by Invima; comply with risk management plans and active pharmacovigilance strategies, and actions that allow the capture, collection, analysis and reporting of adverse events; inform about advances in the development of the drug and if there are changes in the benefit-risk balance that allowed the granting of the permit. Failure to do so can lead to license cancellation, be advised.
This unprecedented mechanism in the country will serve so that vaccines and other products that are still under investigation against covid-19 can be used in Colombia, in the same context in which it has been done in other countries of the world.
(See: Why hasn’t the Pfizer CEO got the covid-19 vaccine?)
HEALTH UNIT
