Download Colombia Regulatory and Funding Process Flowcharts

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts
no text concepts found
Transcript
Colombia Regulatory Drug Approval Process
80-160 days
Colombia Drug Funding/Reimbursement Approval Process
160-280 business days* for approval†
Funding approval timelines unknown
Applicant submits application
to National Institute of Drugs
and Food Vigilance (INVIMA)
Applicant submits
reimbursement request to
Ministry of Health
Review Commission conducts
pharmacological evaluation
Institute for Health
Technology Assessment
(IETS) conducts technical
assessment
Directorate of Drugs conducts
technical/legal evaluation
Ministry of Health makes
final funding decision
80-120 days
INVIMA approves and grants
market authorisation
Applicant activity
National Institute of Drugs and Food Vigilance (INVIMA) activity
Review Commission activity
Directorate of Drug activity
Source: Country member contact, 2013
*Assuming 20 business days in a month
†Approval times based on INVIMA guidelines
October 1, 2013
Drug added to compulsory
health plan (POS)
Applicant activity
Institute for Health Technology Assessment (IETS) activity
Ministry of Health activity
Source: Country member contact, 2013