- Introduction
These setups are essential for pharmaceutical companies and our professionals comply with regulatory requirements and streamline the submission of electronic regulatory documents to FDA (ESG), EMA and national authorities (CESP), EDQM for pharmacopeial standards and CEPs, and MHRA for regulatory submissions in the UK. Each setup involves specific registration processes, obtaining digital certificates or credentials, and configuring systems for secure electronic communication with the respective regulatory authorities or portals.
- ESG is a system used by the FDA (U.S. Food and Drug Administration) for the electronic submission of regulatory information. It facilitates the secure submission of electronic regulatory documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs), and other regulatory submissions required by the FDA.
- Setting up ESG involves registering with the FDA, obtaining appropriate credentials (e.g., ESG account ID, digital certificate), and configuring systems to communicate securely with the FDA’s gateway
- CESP is a portal used for electronic submissions to regulatory authorities within the European Union (EU). It supports the electronic submission of applications, variations, and other regulatory documents according to the requirements of the European Medicines Agency (EMA) and national competent authorities.
- To set up CESP, organizations typically need to register with the portal, obtain digital certificates for authentication and encryption, and configure their systems to communicate with the CESP securely.
- The EDQM is a part of the Council of Europe and plays a crucial role in ensuring the quality and safety of medicines in Europe. It provides standards, guidelines, and services related to the quality of medicines and healthcare products.
- EDQM’s services include the establishment of pharmacopeial standards (e.g., European Pharmacopoeia), certification of suitability to the monographs of the European Pharmacopoeia (CEP), and various pharmaceutical regulatory activities within Europe.
- The MHRA Gateway is a platform used for submitting regulatory information and applications to the MHRA, the regulatory agency responsible for ensuring medicines and healthcare products in the UK are safe and effective.
- Setting up the MHRA Gateway involves registering with the MHRA, obtaining appropriate credentials (e.g., username, password), and configuring your systems to securely transmit electronic submissions to the MHRA.
