In some scenarios, patients around the world need unlicensed or unapproved medicines. This happens when standard treatments have failed or are not yet available in their home country. Healthcare is changing quickly, and Global Access to Unapproved Drugs is becoming important, as new medicines are approved every year by authorities like the U.S. FDA, EMA, MHRA, CDSCO, TGA, and others But these medicines may take a little more time to reach every country.
Because of this delay, zillions of patients, particularly those with serious, life-threatening, or rare diseases, look for access to these new medicines. For such a population, accessing an unapproved or unlicensed drug can become an important support system.
What Are Unapproved Medicines?
Unapproved medicines (also called unlicensed, unregistered, or non-marketed drugs) are medicinal products that:
- Are not authorized for distribution in a specific country
- Have not received national marketing approval
- May be approved in the US, EU, UK, Japan, India, or other regions
- Are still under evaluation/review or in late-stage clinical testing
- Are for rare diseases, small patient groups, or unmet medical needs
Even though such medicines are not sold in a country, patients can legally access them through regulated import pathways when no other treatment is unavailable or unapproved.
Why Do Some Medicines Remain Unapproved in Certain Countries?
There are many reasons why a medicine may not be available or authorized in a particular country:
- The manufacturing company has not applied for national approval
- Local health authorities require more clinical or safety information
- The drug is meant for a rare or ultra-rare disease with less demand
- The medicine is approved only in the company’s main countries, not everywhere
- Issues such as pricing, reimbursement, or regulatory systems can slow down or delay the launch.
- The medicinal product has recently been approved in other countries and has not yet been launched locally
This causes a treatment gap that affects urgent access to unapproved, unregistered, or non-marketed therapies.
Legal and Regulated Access to Unlicensed Medicines:
Several countries in the European Union (EU), the Middle East, Asia, Africa, and Latin America have authorized channels to import unlicensed or unapproved drugs for those with life-threatening conditions. These frameworks are typically known as:
- Named Patient Program (NPP)
- Managed Access Program
- Compassionate Use Program
- Expanded Access Program
- Early Access Program (EAP)
- Special Import License (varies by country)
These mechanisms are for clinicians to access hard-to-find therapies for patients with rare, life-threatening, or treatment-resistant conditions.
How Ikris Pharma International Facilitates Global Access?
Ikris Pharma International operates from its strategic EU-GDP certified warehouse in Belgium. The company supports physicians, hospitals, wholesalers, and authorized importers in accessing unlicensed and hard-to-find medicines directly from regulated markets.
Our Access Capabilities Include:
- Sourcing medicines approved by the FDA, EMA, MHRA, TGA, and other authorities
- EU-GDP compliant handling, storage, and distribution
- Export of specialty, rare-disease, oncology, and orphan medicines
- Support for Named Patient Programs and Special Import Authorizations
- Temperature-controlled shipments with validated packaging
- Full batch traceability and manufacturer-authentic verification
Treatment Areas Where Unlicensed Medicines Are Commonly Needed
Patients may require unapproved or unlicensed medicines for:
- Rare diseases / orphan conditions
- Advanced oncology therapies
- Neurology and genetic disorders
- Immunology and autoimmune diseases
- Enzyme replacement therapies
- Breakthrough biologics and targeted therapies
- Newly approved cell & gene therapies
How the Process Works: Accessing Unapproved Medicines Internationally
Below is a simplified model followed by many countries’ regulatory systems. The actual process generally varies depending on local norms.
- The treating physician writes a prescription for the unlicensed medicine
- Medical justification explaining why local treatments are unsuitable
- Import authorization or special permit from the national authority
- Medicine is sourced exclusively from a regulated supply chain
- EU-GDP-compliant shipment reaches the hospital or authorized importing agency
Quality, Safety, and Regulatory Compliance:
Even in cases where any medicine is “unlicensed” or not approved in a particular country, it must come from a globally approved manufacturer and follow all the strict quality guidelines:
- Original manufacturer-packaged product
- Full documentation support
- Batch Certificate of Analysis (CoA)
- Temperature logs (if required)
- EU-GDP-compliant distribution
This ensures authentic, high-quality, and safe access to unlicensed and unapproved drugs for patients across the world.
Conclusion: Helping Patients Get the Medicines They Need, Wherever They Live
Unlicensed and unapproved medicines are extremely important for global healthcare, mainly for those with few or no treatment options. Through regulated access frameworks, physicians can obtain such therapies that are not yet approved in their home country.
With its EU-GDP certified operations in Belgium, Ikris Pharma International supports global health systems by ensuring safe, compliant, and timely access to essential unlicensed medicines—bridging the gap between medical innovation and patient need.
