Technovation NMRA System:Automating Medicine Regulatory Processes

Empowering National Medicine Regulatory Authorities (NMRAs) to ensure public health and safety.

The Technovation NMRA System is a comprehensive software solution designed to streamline and automate the processes of NMRAs. It offers a one-stop platform for managing all aspects of medicine regulation, from registration and licensing to inspections and pharmacovigilance. It’s a suite of interconnected modules designed to automate specific regulatory functions within an NMRA.

The Technovation NMRA System empowers National Medicine Regulatory Authorities with the tools they need to focus on their core mission: safeguarding public health by ensuring the safety, quality, and efficacy of medicines for their citizens.
Ideal for NMRAs seeking to:

  • Modernize their regulatory processes.
  • Enhance efficiency and transparency.
  • Ensure the safety, quality, and efficacy of medicines for their citizens.

Key Benefits

Enhanced Public Health Protection

  • Protects citizens from counterfeit medicines through rigorous import/export controls and registration processes.
  • Enables effective pharmacovigilance to monitor medicine safety and quality.

Improved Efficiency

  • Automates registration, review, and approval processes for medicines, facilities, and inspections.
  • Integrates with existing systems for seamless data exchange.

Transparency and Accountability

  • Ensures a transparent review process for medicine registration
  • Provides real-time tracking of application statuses.
  • Offers easy access to historical registration data.

 

Seamless Integrations for Streamlined Workflows

By integrating these modules, the Technovation NMRA System eliminates data silos and manual data entry. Information flows seamlessly between modules, creating a more efficient and transparent regulatory process.

  • API-based System: Enables smooth integration with existing NMRA IT infrastructure for data exchange.
  • Single Window Integration: Connects with national single window systems for faster import/export approvals.
  • Communication Module: Facilitates secure communication (email, SMS) with applicants and stakeholders.
  • Laboratory Module (Optional): Allows for sample analysis within the NMRA system (if applicable).
  • Integrates with Payment Channels (e.g., banks) for secure online payments and with Banks for online automated billing.

Core Processes Modules

Product Module

Manages registrations for various medicines (human & veterinary), devices, sundries, food and Cosmetics. Automated dossier management under ECTD framework. Automates workflows and integrates with Finance Module.

Pharmacist Module:

Allows pharmacists to self-register and manage their operating licenses within the system. Streamlines the renewal process and facilitates communication between pharmacists and the NMRA.

Good Manufacturing Practices (GMP) Module:

Facilitates GMP certificate applications, renewals, and inspections. Ensures compliance with quality control standards through automated reporting.

Import/Export Certificate Module:

Manages applications, approvals, and amendments for import/export permits. Integrates with Customs Management Systems (e.g., ASYCUDA, UNIPASS) for real-time permit verification at ports of entry.

Clinical Trial Module:

Streamlines the registration, evaluation, and approval process for clinical trials. Integrates with Communication Module for secure communication with researchers and sponsors.

Post Market Surveillance & Pharmacovigilance Module:

Monitors adverse drug reactions and medical device incidents after products are on the market. Enables reporting of suspected adverse events. Provides data for proactive risk management.

Premise Module:

Handles registrations. Schedules and tracks inspections with the Inspection Management functionality within this module. Integrates with Finance Module for managing premise licensing fees.

Laboratory Module

Supports sample analysis for quality control purposes (if the NMRA has its own laboratory). Integrates with other modules (e.g., Product Module) for seamless data flow related to sample testing.

Administration Module:

Manages user accounts, roles, and audit trails for comprehensive system access control. Manages organisation setups like departments, zones, country etc.

Finance Module:

Handles all financial aspects; setups and transactions of the NMRA's operations. Integrates with Payment Channels (e.g., banks) for secure online payments and with Banks for online automated billing.

Reports Module:

Generates customizable reports on various aspects of NMRA activities (e.g., product registrations, inspections). Integrates with Dashboard Module for real-time visualizations of key performance indicators (KPIs).

Dashboard Module:

Provides a central hub with graphical summaries of data from all other modules. Offers insights for informed decision-making by NMRA leadership.