Changes to e-Submission Requirements for CEP Applications
As part of continuous digital transformation in regulatory processes, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has introduced automation to enhance the management and review of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) submissions.
What is Batch Record Review?
Product quality and regulation standards are of paramount importance in the pharmaceutical manufacturing process. The Batch Record Review (BRR) is one of the most vital aspects that guarantee this compliance. It is a documented verification procedure that either validates or disapproves a drug product upon release that has been produced using Good Manufacturing Practices (GMP), approved procedures and regulatory compliance.
What is Clinical Regulatory Writing?
Clinical Regulatory Writing is a highly specialized type of medical writing which facilitates the development, approval and post marketing surveillance of drugs and medical devices. It includes developing the necessary materials needed by international health regulators, including the FDA, EMA, and MHRA, when performing the clinical trial and regulatory submission procedure.
What is Qualified Person (QP)?
The Qualified Person (QP) is very important in pharmaceutical manufacturing as it ensures that medicinal products adhere to all required quality and regulatory specifications before being released in the market. Pharmaceutical regulations in most countries and especially in the European Union require this role and it is essential to the safety, efficacy, and compliance of drugs.
What is a Drug Regulatory Authority?
In the pharmaceutical sector, integrity of drug development, production, and distribution matters most. The main role of Drug Regulatory Authority (DRA) is to ensure that the pharmaceutical product is of the set standard of safety, quality and efficacy.