- Introduction
These systems are vital for pharmaceutical companies to meet regulatory requirements and facilitate the electronic submission of regulatory documents to authorities such as the FDA (via ESG), EMA and national agencies (via CESP), EDQM for pharmacopeial standards and CEPs, and MHRA for UK regulatory submissions. Each system setup involves distinct registration processes, acquiring digital certificates or credentials, and configuring platforms for secure electronic communication with the respective regulatory portals or authorities.
The FDA has established the Electronic Submissions Gateway (ESG), a secure channel that allows electronic submissions of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and other required filings. It facilitates FDA compliance, keeps data confidential, and speeds up the filing process!
Setting up ESG involves registering with the FDA and receiving necessary credentials (e.g., digital certificate, ESG account ID) and establishing systems to securely communicate with the FDA gateway.
European Union (EU): CESP is a portal for submitting data to regulatory authorities in electronic format. It facilitates the electronic submission of apps, variationsals, and other regulatory docs in accordance with European medicines company (EMA) and nationwide competent authority necessities.
Organizations typically must register with the portal in order to set up CESP and obtain digital certificates for authentication and encryption purposes.
It is a European Directorate for the Quality of Medicines and Healthcare, known as the EDQM — one of the bodies of the Council of Europe with an important responsibility for the quality and safety of medicines in Europe. It sets standards, guidelines, and services for the quality of medicines and other health products.
The services offered by EDQM involve the creation of pharmacopeial standards (e.g., European Pharmacopoeia), the certification of suitability to monographs of the European Pharmacopoeia (CEP), as well as many different pharmaceutical regulatory actions in 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.