eCTD Guidance for Marketing Authorisation and Post-Authorisation Applications in Europe: A 2026 Regulatory Perspective
Most of the regulatory processes in Europe are required to submit Electronic Common Technical Document (eCTD). Standardized electronic dossiers are required by the European Medicines Agency (EMA) and national competent authorities of the Marketing Authorisation Application (MAA) and the Post-Authorisation Application (PAA).
What is a Periodic Safety Update Report (PSUR)?
In the pharmaceutical industry, monitoring the safety of medicines does not stop after a drug is approved and marketed. Continuous safety evaluation is essential to identify potential risks and ensure patient protection. A Periodic Safety Update Report (PSUR) is a key pharmacovigilance document that provides updated safety information about a medicinal product during its lifecycle.
What are Good Practice (GxP) Guidelines and Regulations?
In the pharmaceutical and life sciences industries, maintaining product quality, safety, and regulatory compliance is essential. Good Practice (GxP) guidelines are a set of quality regulations that ensure drugs, medical devices, and healthcare products are consistently produced, tested, and monitored according to strict standards.
What Is eCTD Submission? A Complete Guide for Pharmaceutical Companies
With the pharmaceutical industry being highly regulated today, the regulatory submissions must be precise, organized, and in line with international standards. The Electronic Common Technical Document (eCTD) is one of the most popular forms of regulatory submissions.
What Is eCTD Software
Regulatory submissions in the pharmaceutical and life sciences industry should be done under stringent world standards. The regulatory bodies in most countries of the world demand that the companies provide huge amounts of paperwork in regard to the development of drugs, clinical trials, and quality of the products.