What is the Role of Pharmacovigilance in a Country like India?

Common Technical Document (CTD) is the mainstay of the pharmaceuticals industry and is an internationally accepted standard. Read on to know all about the important questions related to CTD and eCTD application. CTD, or the Common Technical Document, is an agreed document for preparing the applications for registering new medicines. The CTD application is accepted internationally. The registered drugs are designed to be utilized across the leading nations, including the United States of America, Japan, and Europe. The e-CTD is the electronic submission of the application to the respective regulatory authorities of the particular region. If you have been working on a high-end eCTD software application, here are some of the important questions and their relevant answers that you should know about: What is the process of submitting the eCTD format and how to start? The submission of the eCTD application through reliable eCTD publishing services is a vital ...

Know about the overall role of PV (Pharmacovigilance) in India’s healthcare. Read on to understand its meaning and role in various sectors of the Indian economy. Pharmacovigilance, or PV, is known to play a vital role in the country’s healthcare system through the stages of monitoring, assessment, as well as the discovery of various interactions taking place between drugs and their overall effects on the human health. Biotechnological and pharmaceutical medicines are designed for curing, preventing, and treating a myriad of diseases out there. However, at the same time, there is no denying the overall adverse effects of the medicines across its lifecycle in the human body, through the stages of drug development like pre-marketing involving the early stages of designing the drug, conducting clinical trials, and ensuring post-marketing auditing. As such, aggregate reporting of pharmacovigilance is required in most cases. PV or Pharmacovigilance is concerned with th...