?? Rwanda's Road to Excellence: Comprehensive Pharmaceutical Updates
?? From Guidelines to Greatness: Rwanda's Pharma Submission Reforms
?? First Country Focus: We'll start our series with Rwanda, exploring how these new guidelines are set to transform the pharmaceutical landscape.
?? Main Updates:
1. Comprehensive Guidelines: Detailed instructions on preparing and submitting documentation for pharmaceutical products.
2. Quality, Safety, and Efficacy: Ensuring that all registered products meet the highest standards.
3. Streamlined Processes: Simplified procedures to accelerate the registration process.
4. International Standards: Alignment with WHO and ICH guidelines for harmonized regulatory practices.
5. Abbreviated Procedures: Introduction of abbreviated procedures for products approved by recognized reference regulatory authorities to reduce duplication of effort and expedite the registration process.
6. Application Requirements: Updated requirements for application submission, including changes in the mode of application submission.
7. Registration Certificate Content: Updates to the content and format of the registration certificate.
8. Application Processing Timeline: Revised timelines for processing applications to improve efficiency.
9. Pack Size Limitation: Removal of the HDPE container pack size limitation to 90 units.
10. Annex X: Addition of an annex for the application form for a biowaiver addition strength.
?? Read the full guidelines here
?? Stay Informed. Stay Compliant.
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