Global RLD Intelligence (RLDi) – Approved Products Explorer

Reference Drug and Approved Products Assessment for Global Regulatory Strategy

QuriousRI’s Global RLD Intelligence offers evidence-based assessment and intelligence to identify reference drugs across key RLD attributes. You can name the molecule, select your target markets and for each country QRI’s RLDi module will provide the approved product that you can reference in each country based on evidence and agency’s comparator rules.

RLDi Decision Engine

Regulatory professionals within organizations spend days searching national registers, databases, evaluating regulatory guidelines, reconciling brand names per country, per product across multiple countries. Further, there is no audit trail or centralized process. RLDi’s decision engine assesses following parameters using multiple attributes,

• Identification of originator’s product registration status (different brand name, marketing authorization holder as applicable)
• Ability to reference the drug
• Agency’s comparator status
• Bridging studies requirements

Attributes Assessed through RLDi Decision Engine

For each molecule and selected markets, QuriousRI’s RLDi engine assesses the molecule to identify the reference comparator drug using following attributes.

Deliverables: RLDi / Approved Products Assessment

Evidence Based Strategy Using Reference Label Drug / Approved Products Assessment

Decisions Per Market:

Per market evaluation report for drugs if they are available, available under another brand name, not registered or need a decision. Each evaluation is stated plainly for each country, each strength.

Evidence Based:

All evaluation attributes tracked with references per country: brand, marketing-authorisation holder, registration number, strengths, dosage form, route, approval status, etc.

Comparator Guidelines from Agency, Bioequivalence Wavier:

Evaluation of each health authority’s acceptance of reference product, acceptance of foreign reference, applicability of bridging studies etc.

Save Decisions for Gap Assessment and Dossier Authoring:

You can save the decision recommendations or override; each decision is saved to apply in reports, re-runs or use the decision for Dossier Gap Assessment and Authoring for respective countries.

Multiple Product Portfolio Assessment Reports:

Export assessment reports in excel, word or pdf format for entire portfolio in global markets

Key Benefits

• Enabling faster go to market through reference drug confirmation
• Assess Global Markets Simultaneously, Make Decisions, Saves Time on Searches
• Continuous Data Update for any new registrations or change in registrations
• Faster evaluation and decisions on BE studies requirements
• Evidence based, consistent reports across markets
• Access 50+ markets insights

Conclusion

Choosing the right reference drug across different markets is essential for developing an evidence-based regulatory strategy. RLDi simplifies this process by supporting reference product identification and country-specific regulatory assessments.

Explore Artixio’s QuriousRI regulatory intelligence platform to learn more about its solutions for global pharmaceutical regulatory planning.

FAQs

1. What exactly does RLDi (Approved Products Explorer) do?

RLDi/ Approved Products Explorer provides evidence based assessment for identification of reference label drug in target market. It is assessed based on multiple attributes described above to identify the registration pathway, registration classification (new drug, new generic, generic etc), bridging study requirements and agency guidelines for registration in the market.

2. How is RLDi different from manually searching national registers myself?

Manually searching the reference drug in national registers require searching each country’s register manually, evaluate guidelines, analyse the data to arrive at decision, often requiring significant manual effort and time. RLDi/ Approved Products Explorer offers single platform to access multiple countries (50+) and inbuild decision engine to expedite the process and provide evidence based decision support for RLD identification to build further regulatory strategy.

3. What sources does RLDi pull from, and are they cited?

The reference label drugs information is sourced directly from health agency sources across FDA, EMA, UK MHRA, NPRA, TGA, HSA, Taiwan FDA, CDSCO, ANVISA, COFEPRIS and other countries in scope.