PHARMA LITERATI

15. What is a Marketing Authorization Application? It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRA-Applications for new active substances are described as 'full applications'. Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’. 16. What is an ASMF? Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance. In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”. 17. What are the types of active substances for which ASMFs are submitted...

Dear All, We are starting a new series on knowledge sharing from today. In this series, we would share relevant articles in the field of pharmaceutical industry.   Recently received an email sharing the information relating to regulatory affairs activities in pharmaceutical industry. We are reproducing the same for our readers.   1. What is Regulatory Affairs? Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. 2. What are the goals of Regulatory Affairs Professionals? Protection of human health Ensuring safety, efficacy and quality of drugs Ensuring appropriateness and accuracy of product information. 3. What are the Roles of Regulatory Affairs professionals? Act as a liaison with regulatory agencies Pr...