INVIMA Requirements for a Pharmaceutical Drug Clinical Trial Protocol Approval
We will can assist you in submitting your pharmaceutical or biotechnology drug study protocol approval application. Learn about the requirements for an investigational medical device clinical trial.
Our US and Colombia-based team will assist you in gathering the necessary documentation, translating it to local Colombian Spanish —by an official translator certified by Colombia's Ministry of Foreign Affairs—, completing and submitting the application to INVIMA (National Institute of Food and Medicine Surveillance or Instituto Nacional de Vigilancia de Medicamentos y Alimentos in Spanish).
Prior to submission to INVIMA, the research protocol must be sent to a local ethics committee. Each local committee has its own scheduling and processing times.
The committee’s approval will be delivered in writing and the information included in that document depends on each committee’s procedures. Once the authorization is obtained, the document must be included in the application submitted to INVIMA. If the local ethics committee rejects the application, the clinical trial cannot be conducted, and the application cannot be submitted to INVIMA.
All research on human beings shall be evaluated and approved by the local ethics committee affiliated to the site where the trial will be conducted. The committee must evaluate the protocol, the informed consent form, all information known on the medical investigational product (including reports of unexpected adverse events) and all potential advertising planned to obtain participants.
The INVIMA approval will authorize the sponsor's local legal representative in Colombia to the following:
- The conduct of the clinical trial
- The centers and investigators
- The importation of the investigational drugs
- Biological material and other devices and supplies required by the study
- The export of biological material to an external laboratory
The Drug Information Association (DIA) has a useful presentation that outlines Colombia's regulations and features titled "Hands-on the Regulations in Colombia."
List of Requirements
- Document checklist form: ASS-RSA-FM046
- Protocol evaluation form: ASS-RSA-FM055
- Clinical research protocol (in English and Spanish). It must include:
- Scientific justification
- Justification and use of results (objectives, applicability)
- Primary, secondary endpoints, and duration of endpoints
- Theoretical background and framework (argumentation, hypothesis). The intent of this framework is to facilitate communication between researchers and stakeholders in conceptualizing the research problem and the design of a study (or a program of research involving a series of studies) in order to maximize the potential that new knowledge will be created from the research with results that can inform decision making. To do this, research results must be relevant, applicable, unbiased and sufficient to meet the evidentiary threshold for decision making or action by stakeholders. In order for the results to be valid and credible, all persons involved must be committed to protecting the integrity of the research from bias and conflicts of interest. Most importantly, the study must be designed to protect the rights, welfare, and well-being of subjects involved in the research.
- Research objectives (general and specific)
- Methodology (operationalization, type and study design, universe, power calculation, analysis and observation unit, inclusion and exclusion criteria, description of the intervention, procedures to capture information, tools and methods for data quality control, procedures to guarantee the ethical conduct of the study, characteristics of the placebo application.
- Data analysis plan: Methods and modeling for data analysis according to the variables, software to be used for data analysis.
- Patient information sheet
- Change control section
- Data capture tools
- Patient ID cards
- Bibliographic references
- Study project timeline
- Study budget
- Local Ethics Committee approval letter
- Insurance policy certificate
- Protocol name
- Investigator(s) name
- Site name and address
- Valid during the duration of the study (at least two years is recommended)
- List of adverse events that it covers (description of the AE's that will be covered, which ones will not, in what instances, etc.)
- Issued by a local Colombian or foreign insurance agency
- Investigator's brochure
- Informed consent (general, biological and genetic) and assent (if applicable) —according to Article 15 and 16, Ministry of Health’s Resolution No. 8430 of 1993). INVIMA form ASS-RSAFM048.
- Product shelf life (results on the product stability studies that support its shelf life and a certification on the analysis of the product lot that will be tested). INVIMA form ASS-RSA-FM088.
- Product labeling
- Product importation documents
- Free sale certificate from the country of origin (or its equivalent for drugs, medical devices, biomedical equipment, and diagnostic reactives)
- Authorization from INVIMA's Health Supplies Group to import used biomedical equipment (if applicable)
- GCP-certified clinical research site presentation form: ASS-RSA-FM050
- Principal investigator presentation form: ASS-RSA-FM051. A separate form must be completed for a co-investigator
- Principal investigator CV (and co-investigator when applicable)
- Copy of principal investigator(s) bachelor's degree certificate and diploma
- Copy of principal investigator(s) graduate degree certificate and diploma
- Copy of principal investigator(s) medical license
- Copy of principal investigator(s) Colombian National ID card
- Copy of principal investigator(s) GCP training certificate
- Letter signed by the principal investigator(s) stating that he/she will comply with international guidelines for the conduct of clinical trials
INVIMA's Drugs and Biological Products Committee (Sala Especializada de Medicamentos y Productos Biológicos in Spanish) meets approximately every 30 days. It decides whether the protocol in question is approved or not and issues meeting minutes to notify the interested party, which is published on INVIMA’s official website.
Within the approval application, the interested party shall also include the import request for the investigational drug and all other necessary supplies to run the study, as well as the application to export biological samples to be evaluated by laboratories outside of Colombia.
The legislation does not provide a defined timeline for the review and approval of the clinical trial application. However, normally it takes about 60 days to assess and approve the application; the approval may take additional time if further documentation is requested. Protocol submissions must be sent to INVIMA's Drug and Biological Products Committee by the dates specified below.
2018 Drug Committee Meeting Dates
- May 21-22: (submission deadline: Mar. 16)
- Jun 18-19: (submission deadline: Abr. 20)
- Jul. 13-16 (submission deadline: May 18)
- Aug. 17-21 (submission deadline: Jun. 15)
- Sept. 14-17 (submission deadline: Jul. 13)
- Oct. 12-16 (submission deadline: Aug. 10)
- Nov. 23-26 (submission deadline: Sep. 14)
- Dec. 14-17 (submission deadline: Oct. 12)
A separate application for an import permit approval to the Ministry of Industry, Commerce and Tourism (VUCE office) —for each shipment— must be obtained to legally import the drugs and additional accessories named on the clinical supply list on the INVIMA submission. The average processing time is between 5 to 10 business days.
- All documents must be translated to the "Colombian" Spanish dialect. The Spanish spoken in Latin America changes from country-to-country and INVIMA has rejected documents such as an Informed Consent Form that is not easily understood by an average native Colombian citizen.
- We recommend that sponsors translate their documents by Colombian Spanish-speaking translators certified by the Colombian Ministry of Foreign Affairs.
- A certified translator is a person who has passed the linguistic proficiency test from the relevant agency designated by the Government of Colombia for this purpose. Any translator who passes this test should take office before the Superior Tribunal of the Judiciary District and apply for a certification from the Ministry of Justice and Law, which will accredit him or her as an official certified translator. The certified translator must register his name with the Ministry of Foreign Affairs by submitting a copy of the Oath of Office and a copy of the certification issued by the Ministry of Justice and Law.
- Interventional Concepts offers its sponsors certified translation services and works with local Colombian certified translators duly endorsed by the Ministry of Foreign Affairs (who therefore, hold the relevant certification issued by the Ministry of Justice and Law) with past experience in the clinical research industry. This will ensure that our sponsor's translations as accurate, faithful and valid to be presented to any government agency such as INVIMA.
- Although INVIMA doesn’t specifically require that sponsors submit documents translated to Spanish by official government-certified translators, it’s customary —and expected by the recipient of the document— in Colombia that all translations (both in private business and government dealings) are done by government-certified translators.
- Just like there are differences in English expressions, spelling, industry and business terminology among English-speaking countries (USA, UK, Australia, Canada, etc.) Spanish varies throughout Latin America. Colombian Spanish has its own peculiarities just like Mexican or Argentinian Spanish have. For Colombia’s INVIMA purposes, this is important in two ways: a) the evaluation committee members should be able to easily understand the protocol, the investigator's brochure (IB), and all other study-related documents, and b) the patient's informed consent form (ICF) should be written in such a way that an average Colombian native citizen is able to easily understand (there have been cases where the committee has rejected ICFs for being written in non-Colombian Spanish).
- A printed document that has been translated by a certified translator in Colombia will have (by law) the following elements:
- A "Certified Translation" header.
- A consecutive certified translation control number.
- The seal of the official translator in which the translator's full name, his or her certification number issued by the Ministry of Justice, the certification issue date, and the languages that the translator is certified to translate.
- The signature of the translator in the last page, or at least, the initials of the translator if the document has several pages.
- Through a seal and a signature, the translator certifies that the translation is correct and complete and takes responsibility for what is translated. This way, the translator basically acts like a notary authenticating a document. A certified translator is also authorized to be an official interpreter, translating declarations and affidavits before a notary or a judge.