The Colombian healthcare system prioritizes patient safety and access to effective medications. To achieve these objectives, the National Institute of Drug and Food Surveillance (INVIMA) acts as the central Regulatory authority overseeing the approval process for pharmaceuticals.
This blog serves as your guide, unlocking fifteen (15) most Frequently Asked Questions (FAQs) on the drug approval process in Colombia.
- Who can submit a drug for approval in Colombia?
Pharmaceutical companies, research institutions, or their Authorized Representatives (ARs) can submit applications.
- What are the steps involved in the drug approval process?
The process typically involves conducting pre-clinical and clinical trials, data compilation, application submission, review by INVIMA, and potential inspections.
- Can traditional medicines be submitted for approval in Colombia?
Yes, INVIMA has a specific pathway for evaluating the safety and efficacy of traditional/herbal medicines submitted for approval.
- What if my drug is already approved elsewhere (e.g., United States [US] or Europe)?
While foreign approval can be helpful, a separate application with data specifically relevant to the Colombian population is still required. However, INVIMA may accept some existing data to expedite the process.
- What are the fees associated with drug applications in Colombia?
INVIMA charges fees based on the type and complexity of the drug application.
- What documentation is required for submission?
You need to prepare a comprehensive dossier, including detailed information on the drug, its manufacturing process, along with the clinical trial data.
- Can I track the progress of my application?
Yes, INVIMA offers online tools for you to track the status of your application.
- What happens if my application is rejected?
In case your application is rejected, INVIMA provides you with an opportunity to address the deficiencies and resubmit the application.
- Are there different approval pathways for innovative drugs?
Yes, INVIMA offers expedited pathways for potentially life-saving or breakthrough drugs.
- What are the post-approval requirements?
Companies must maintain pharmacovigilance practices to monitor the drug’s safety profile after its launch in the market.
- Can I import a drug that is not yet approved in Colombia?
Limited exceptions exist in the form of compassionate use programs, which provide a pathway to import drugs that may not have been approved yet, for critically ill patients.
- Are there any specific requirements for pediatric drug approval?
Yes, INVIMA has strict regulations in place for the testing and approval of drugs intended for children. These may involve specific studies and considerations for safety and efficacy in younger age groups.
- How can I find information on approved drugs in Colombia?
INVIMA maintains a public database listing for all authorized medications.
- What are the ethical considerations for clinical trials?
INVIMA’s strict regulations ensure informed consent and participant protection during clinical trials.
- Are there any cost-saving options for smaller companies?
Yes, INVIMA offers reduced fees and streamlined processes for applications from small and medium-sized enterprises developing essential or generic drugs.
To sum up, you must have a deep understanding of INVIMA’s regulations to effectively navigate Colombia’s drug approval process and ensure the safe and timely introduction of your drug into the market. Partner with Freyr, your global Regulatory services provider, and we will empower you to comply with these regulations, facilitating a swift and secure journey throughout the approval process.
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