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Streamlining Medical Product Approvals and Implementing Value-Based Pricing in Colombia

Colombia’s National Institute of Food and Drug Surveillance (INVIMA) has taken a significant step towards modernizing its regulatory landscape. The recently published draft plan proposes simplified processes for medical product approvals, aiming to accelerate access to essential therapies while maintaining robust safety and efficacy standards.

Key Highlights of the Draft Plan

Simplified Approval Process: INVIMA’s proposed adjustments will reduce administrative burdens, facilitating quicker market entry for medical products.
Value-Based Pricing Methodology: A major innovation in the plan is the introduction of value-based pricing for pharmaceuticals. This pricing model evaluates a drug’s cost-effectiveness and clinical benefits, ensuring patients access affordable therapies while encouraging innovation.
Enhanced Collaboration: INVIMA aims to foster stronger partnerships with global regulatory bodies and leverage mutual recognition agreements to expedite product approvals.

Impact on the Pharmaceutical Industry

These reforms signal an opportunity for pharmaceutical companies looking to enter the Colombian market. Streamlined processes reduce time-to-market, while value-based pricing creates a fair and transparent pricing environment.

How Freyr Solutions Can Help

Navigating regulatory changes can be complex. Freyr Solutions offers end-to-end regulatory support, ensuring compliance with INVIMA’s latest standards. Our comprehensive services include:

Regulatory Strategy and Consultation
Product Registration Support
Market Access Assistance
Compliance Management

Stay ahead of regulatory developments and ensure a successful product launch in Colombia with Freyr Solutions by your side.

Contact us today to learn more about our tailored regulatory solutions.

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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What is INVIMA’s New Draft Plan?

Streamlining Medical Product Approvals and Implementing Value-Based Pricing in Colombia

Key Highlights of the Draft Plan

Impact on the Pharmaceutical Industry

How Freyr Solutions Can Help

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