Continental API

Introduction

The API Database serves as a repository of information on APIs approved/accepted by various recognized institutions/regulatory bodies. It is designed to be used by NRAs, RECs, Continental EMP TC, GMP TC, and eventually AMA in decision-making for implementing reliance on regulatory approvals for APIs.

Key Features

• Keep records of all important API information for regulatory purposes, research, and manufacturers.
• Allow uploading of evaluation reports of specific APIs by EMP TC, RECs, and recognized NRAs.
• Allow uploading of inspection reports of API manufacturing sites by GMP TC, RECs, and recognized NRAs.
• Allow updating, verification, commenting, and sharing of other API information as deemed necessary.
• User-friendly interface categorized into four groups: regulators interface, researchers interface, manufacturers interface, and public domain.
• System integration with other systems like Regulatory Information Management System (RIMS) such as the AMA RIMS and RECs RIMS.
• Accept more than one language for versatile usage.

System Integration

The API Database is designed to seamlessly integrate with other systems like Regulatory Information Management System (RIMS), including the AMA RIMS and RECs RIMS.

User Interfaces

The system provides user-friendly interfaces categorized into four groups: regulators interface, researchers interface, manufacturers interface, and public domain.