We can help you register and obtain marketing authorization of your biologics or chemical synthesis drug at INVIMA, find a distributor, access the market, and ensure your long-term sales success in Colombia. We can also help you in other countries in Latin America
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Pricing (USD)
bioaccess™ Professional Fees:
Common technical documents (CTD) review, product classification, gap analysis, and gap closure plan: $2,999.
Dossier assembly and submission for a new or renewed pharmaceutical drug registration: $7,999.
INVIMA official application fees:
Pharmaceuticals:
Pharmacological, technical, and legal evaluation: $3,000.
Biologics:
Pharmacological, technical, and legal evaluation: $15,000.
Timeline
12-24 months (estimated based on the processing time at the time of submission).
Notes: INVIMA official fees are estimated based on currency exchange fluctuations and assume that your manufacturing plant has a GMP/GLP certificate from a reference country (USA, Canada, Germany, Switzerland, France, U.K., Denmark, Netherlands, Sweden, Japan, and Norway), or issued by the F.D.A., WHO/PAHO, and EMA. INVIMA fees will be substantially higher if your manufacturing plant does not have a GMP/GLP certificate from a reference country (INVIMA will visit and audit your manufacturing plant to issue a GMP/GLP certificate).
Frequently Asked Questions (FAQ)
What are the different pharmaceutical drug registration classifications in Colombia?
Generic drug or new drug.
What is the registration procedure?
bioaccess gap analysis of your technical file.
INVIMA plant audit for BPM and BPL certification (in case your plant doesn't have a GMP certificate from a reference country [USA, Canada, Germany, Switzerland, France, U.K., Denmark, Netherlands, Sweden, Japan, and Norway], or issued by the F.D.A., WHO/PAHO, and EMA).
INVIMA technical and legal evaluation of your dossier (requirements include pre-clinical studies, pharmaco*kinetics & pharmacodynamics, clinical studies, and risk-benefit analysis).
Should we need to conduct the product tests (nonclinical test, clinical trial, etc.) in Colombia?
No.
Will there be an on-site GMP inspection by INVIMA to our manufacturing site before the technical and legal evaluation and approval of your dossier for drug registration?
Yes, if your plant is doesn't have a GLP and GMP certificate from a reference country (USA, Canada, Germany, Switzerland, France, U.K., Denmark, Netherlands, Sweden, Japan, and Norway), or issued by the F.D.A., WHO/PAHO, and EMA.
My plant doesn't have a GMP certificate from a reference country or issued by F.D.A., WHO/PAHO, or EMA. Can bioaccess™ come to our plant with an expert auditor and prepare us for the INVIMA inspection?
Yes. bioaccess™ works with former INVIMA auditors who can visit your plant for 3-5 days, do a thorough audit, and prepare you for the INVIMA inspection.
Can our foreign entity in China or India be the titleholder of the INVIMA registration certificate or will we need to appoint a local entity as our registration holder?
Yes. Your foreign entity will be the marketing authorization holder (MAH) of your registration certificate. You don't need to contract the services of a local entity in Colombia to be your third-party MAH.
Our company is not the manufacturer of the drug that we intend to register at INVIMA. The manufacturer has authorized our company to register and obtain marketing authorization, distribute, market, and sell the drug in Latin American countries. In this capacity, as an authorized agent/reseller, can we still register the drug at INVIMA and be the MAH?
Yes, your company, as an authorized agent/reseller, could be the MAH in Colombia. This doesn't apply to other countries in Latin America. Most other countries in the region do not allow foreign entities to be the MAH. In other countries, you'll need to hire the services of a local company to be your MAH.
Does bioaccess™ have experience registering drugs in Latin America?
Yes. Our director of regulatory affairs, Harvey Jaramillo, has over 10 years of experience registering and obtaining marketing authorizations for almost 90 new drugs (synthetic and biologics) in 10 countries in Latin America. Read more about Harvey here.
Can bioaccess™ help us register and obtain marketing authorization for our drug in other countries in Latin America besides Colombia?
Yes, we can.
What's the timeline, fees, and process to register a drug in other countries in Latin America?
See this table here.
Do we need to ship samples of the drug that we intend to register at INVIMA in Colombia?
No.
What's the validity of a drug registration certificate from INVIMA in Colombia?
Five (5) years.
Does INVIMA accept Chinese pharmacopeia?
Colombian law (Art. 22, Decree 677 of 1995) does not accept Chinese pharmacopeia. The officially accepted pharmacopeias in Colombia are the following: United States of America (USP), British (BP), French Codex, German (DAB), European and International (WHO), or the one in force for the European Union. INVIMA will use the most current edition of the officially accepted pharmacopeias.
Since our product is stored at 2-8℃, we have conducted the long-term stability test under 2-8℃ and accelerated stability test under 25℃ and RH60%. Will INVIMA accept this data?
INVIMA will accept accelerated stability tests. INVIMA will only accept shelf-life tests results based on natural stability.
Is there any limitation on the number of biosimilars for the same product?
There is no limit on the number of biosimilars for the same product that is allowed in the country.
Regarding human studies, how many studies does INVIMA require for biosimilars in the comparative studies with the innovator drug?
Colombian law (Art. 7, Decree 1782 of 2014) does not specify a specific number of studies. As it seems that we will request approval by way of comparability, the most important thing is the physical, molecular, and biological characterization of the product compared with the comparator product.
Do you know which documents needed to be notarized or attested?
For now, just the certificate of pharmaceutical product (CPP) or free sale certificate (FSC), depending on the type of document your country issues. Once we review your dossier and the parties' relationship (manufacturer, licensor, licensee, marketing authorization holder, importer), we will determine what additional letters of authorization you need to legalize or apostille. Since China is not part of the Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (aka the Apostille Convention or the Apostille Treaty), you will have to legalize the document(s) at a Colombian consulate in China.
Could we submit the drug registration application online or do we need to find a local representative to submit hard copies of the application to INVIMA？
Colombia's INVIMA provides a virtual platform (in Spanish) to submit applications online. You can visit that page and submit your application here. You'll need to create a username and password, and provide the contact information of your local legal representative.
INVIMA Process
INVIMA, established by the Colombian Ministry of Health to inspect and supervise the production and marketing of health products in the country is a leader in the region, holding level four status with the World Health Organization (WHO).
A registration certificate from INVIMA is required to obtain operating licenses for marketing authorization (MA)for new medicines and for medicines already included in the Colombian Pharmacological Code.
To obtain MAs for new medicines, the applicant must first submit a pharmacological evaluation application. The pharmacological evaluation studies the safety and efficacy of the drug and is performed by the Medicines Reviewing Committee, which takes into account the following features: efficacy, safety, dosage, indications, contraindications, warnings, toxicity, trading conditions, and restrictions.
Alternatively, article 27, paragraph 1 of Decree 677 of 1995 provides an abbreviated procedure for innovators by means of which INVIMA can forego conducting a pharmacological evaluation (safety and efficacy) of a product whenever such product is already approved in at least two reference countries and has not been rejected in any of the other reference countries.
A pharmacological evaluation must be performed even if the active ingredient (drug substance) is already included in the Colombian Pharmacological Code. This evaluation assesses the efficacy (indications, contraindications, interactions, precautions, warnings, pharmaco*kinetics, pharmacodynamics, dose, risk-to-benefit ratio) and safety (adverse effects, immunogenicity, trading conditions, special restrictions, and risk-to-benefit ratio).
For biologics, specific requirements for the submission of information for pharmacological evaluation are detailed in Decree 1782 of 2014. This Decree contains an abbreviated route, by means of which biosimilar products should not have to submit clinical trials, or head-to-head comparability assays to demonstrate their safety and efficacy. Mandatory immunogenicity assays and a perfect characterization of the API and its manufacturing procedure will be required for applicants even if they choose the abbreviated route.
Once the pharmacological evaluation is approved, the new medicine is included in the Colombian Pharmacological Code (when not previously included, in the case of biologicals). Subsequently, an MA application can be filed, which involves a pharmaceutical and a legal evaluation.
The pharmaceutical evaluation evaluates the capabilities of the manufacturing process and the product’s quality (chemistry manufacturing and controls). The legal evaluation focuses on the legal documentation filed by the applicant, in compliance with the regulations governing this matter.
Finally, to obtain MAs for medicines already included in the Pharmacological Code (excluding biological products), generic applicants can proceed directly to filing the MA application (subject to the pharmaceutical and legal evaluation of the product).
INVIMA Requirements
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1. INVIMA application form, signed by the empowered or legal representative of the solicitor or owner, and including the name of the product, brand (if applicable), name of the owner, name of the manufacturer, category, and a statement confirming that the legal and technical information provided is accurate. (Original)
2. GMP certificate from country of origin, if the manufacturer hasn’t been visited by INVIMA. The validity of this document will be the one stated in it, otherwise, it will be set at 1 year.
3. Certificate of existence and legal representation of the solicitor, manufacturer(s), importer(s), and/or packager(s) issued within the last three months.
4. Power of attorney authorizing representative to file the application.
5. Certificate issued by the Colombian patent & trademark office (aka Superintendencia de Industria y Comercio), stating that the trade brand is registered in the name of the solicitor or that its registration has been requested and is under processing. When the owner of the brand is not the solicitor, authorization for use from the owner must be attached.
6. Receipt or proof of electronic transfer of the applicable fee.
7. Certificate of pharmaceutical product (CPP) of origin, compliant with the requirements of Decreto 426 de 2009. The validity of this document will be the one stated in it, otherwise, it will be set at 1 year.
8. Express authorization from manufacturer or owner to importer, to request marketing authorization, use the brand and commercialize the product, if applicable.
9. Pharmaceutical form and commercial presentations of the drug product.
10. Composition or quantitative formula, divided into two sections: API and excipients.
11. Structural and condensed chemical formula of APIs.
12. Manufacturing batch formula.
13. Detailed description of the manufacturing process.
14. Analytical methods, in accordance to pharmacopeia or properly validated, and validation reports for non-pharmacopoeial methods.
15. Summary of pharmacological information.
16. Stability studies and shelf life, based on international standards such as ICH or official pharmacopeias.
17. Results of bioavailability and bioequivalence studies.
18. Quality specification for raw materials.
19. Quality specification for product-in-process.
20. Quality specification for the finished product.
21. All labeling material: packaging, labels, leaflets, etc.
Special Requirements for Biologics
According to Title II, Decree 1782 of 2014, for the pharmacological evaluation of biologics, the information provided to INVIMA should cover the following characteristics of the drug intended to be approved:
Efficacy:
Indications, contraindications, interactions, precautions, and warnings.
Pharmaco*kinetics.
Pharmacodynamics.
Dosage.
Risk-benefit analysis.
Safety:
Adverse effects.
Immunogenicity.
Conditions for commercialization.
Special restrictions.
Risk-benefit analysis.
Regardless of the application pathway (i.e., complete dossier, comparability, abbreviated comparability), the following are the common requirements:
A detailed description of the process and place of production.
Expression system.
Biologics identity tests.
Potency evaluation.
Physicochemical properties.
Biologic activity evaluation.
Purity evaluation.
Immunogenicity tests.
Risk management plan.
Source: INVIMA (in Spanish)
Our Experience
Harvey Jaramillo, our director of regulatory affairs, has over ten years of experience in the pharmaceutical industry in Latin America, including five years in managerial positions for top global Pharma companies. Harvey has a deep knowledge of the regional biopharmaceutical sector and has ample experience obtaining marketing authorizations for new drugs and medical devices in several countries in the region. Harvey has had several Latin America regulatory affairs leadership positions at global Pharma companies, including Bausch Health, Sanofi Aventis, Sanofi Genzyme, and Sanofi Pasteur. Harvey has been accountable for more than 105 new marketing authorizations, including 86 drugs and 19 medical devices of all risk levels in 10 countries. Harvey's regulatory drug experience includes new chemical entities including biologics and chemical synthesis products such as monoclonal antibodies, proteins, hormone analogous, vaccines, and other bioavailability and bioequivalence requirements. Harvey has been instrumental in the regulatory registration of Dupixent, Praluent, Somatuline, Dengvaxia, Lantus, Botox, Cerdelga, Cerezyme, and Synvisc, among others.
In his earlier career, Harvey worked at Colombia’s trademark and patent office (SIC) as a technical evaluator for new patent applications in the pharmaceutical and chemical sector. His duties included determining the degree of novelty and inventive level of applications (i.e., polymorphism, Markush claims, processes). Before SIC, Harvey worked as part of the drug technical evaluation team at Colombia’s Invima. At Invima, he advised and worked alongside the deputy director of drug registrations to manage 42 reviewers and seven attorneys and assessed applications for new registrations, renewals, amendments, emergency use authorizations, and donations.
Harvey has a bachelor's degree in pharmaceutical chemistry from the Antioquia University in Medellín, Colombia, and a degree in management and pharmaceutical marketing from Universidad del Bosque in Bogota, D.C., Colombia.
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