Invima has issued a series of decrees and resolutions with the aim of improving response times in procedures related to medicines. The main Decree is 334 of 2022, which establishes provisions for the renewal, modification and suspension of health registrations for various types of medicines, as well as information and advertising of pharmaceutical products and measures to guarantee the supply of certain medicines. However, its entry into force has been partially postponed until guidelines for its proper implementation are issued.
The process of preparing the guidelines suffered some problems in 2022, as they failed to capture the initiative of the standard and resulted in the repetition of requests for information and unnecessary procedures. This year, the Ministry of Social Protection took on the task of developing the guidelines in collaboration with the pharmaceutical industry, which led to the issuance of decrees to reactivate part of the procedures included in the base standard. One of the most significant decrees is 1474, which modifies the validity granted to health registrations of medicines, establishing that it will be indefinite as long as the previously approved conditions are maintained, although measures are allowed to be taken if the technical standards are not met or a health risk associated with pharmacovigilance is identified during the use of the medicine.
In addition, Decree 1474 establishes modifications in administrative-legal aspects, quality aspects related to minor, moderate and major risk changes, and measures to prevent and mitigate drug shortages. To ensure efficiency in the application of these standards, joint working groups were held between the pharmaceutical industry associations, Invima and the Ministry of Health and Social Protection. A two-month transition period was agreed to socialize and appropriate the guidelines before the Decree comes into force, which is scheduled for November.
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