National Medicine Regulatory Authorities (NMRAs) are mandated to;
- Ensuring that medicines in circulation in the country are safe, efficacious and of good quality.
- Regulating the practice of pharmacy and trade in drugs.
- Evaluation and registration of pharmaceutical products.
- Promote and control local production of essential drugs
- Control the importation, exportation and sale of pharmaceuticals
- Promotion of rational use of drugs
- Inspection and surveillance activities
- Licensing of personnel and institutions
- Clinical research authorization
- Advising the Government on any matter relating to regulation of drugs
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Registration of medicines, premises, medical devises and managing their import export requires thorough quality control testing in order to ensure that the they meet quality specifications.
Technovation have worked Closely with East Africa NMRAs to come up with a comprehensive system that automate implementation of their mandates.
The NMRA IMS have provide solutions to major challenges that comes with ensuring medicines within the country are safe, efficacious and of good quality. The system;
- Protects citizens from counterfeit medicines through well managed import and exports, proper drug, premises and GMP registrations.
- Helps government to carrier out effective pharmacovigilance; post-marketing surveillance activities, including random sampling of registered medicines for quality control
- Maintenances of a accurate and reliable register of available products and premises
- Fast truck the lifesaving process by speedup the importation of key medicines for health facilities (Hospitals, etc)
- Protects citizens from Skin cancer due to non-registered and certified cosmetics (Registration of cosmetics and medical devices)
- Ensures Transparent Review Process (Good Review Practices)
- Have Real-Time Monitoring of Current Registration Applications under Review
- Have Easy Access to Medicine Registration Historical Data (Retention, Renewal, Withdrawal, Suspensions)
- Have Efficient Registration Process
- Streamlining the Medicine Registration Review Process
- Follows the Common Technical Document (CTD) in dossier submission
The Major functionalities of the NMRA IMS are;
- Fully automated (registration, review and approval) Drugs, GMP, Premises, Import Export, inspections processes
- Customized API based system that can be easily integrated to existing systems
- Integrates with Single window systems for automated import export release or
- Integrates with Customs management information’s System (ICMS, ASYCUDA, UNIPASS, SIMBA etc.)
- Integrates with Banks for online automated billing
- Integrates with SMS and email system for automated real-time notifications
- Dash board and Advanced reporting capabilities
- Easy to use user interface and process flows