How CMDh helps Marketing Authorisation Holders (MAHs) to facilitate regulatory procedures during the COVID-19 crisis?
The SARS-CoV-2 virus pandemic has undoubtedly affected various areas of our lives, not only our private lives and interpersonal contacts, but it has also firmly affected the areas of lives directly related to work and career. Even pharmaceutical industry directly connected with medicinal products production and responsible for medicinal products marketing was strongly affected by COVID-19 pandemic situation.
From the regulatory point of view, the crisis caused by the COVID-19 pandemic has led to many problems related to registration procedures of medicinal products, post-registration variations proceeding and renewal procedures. This article, based on ,,Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis” (May 2020; CMDh/418/2020, Rev.1), will briefly discuss new regulatory opportunities directly related to regulatory affairs issues, enabled, by Co-ordination Group for Mutual Recognition (MRP) and Decentralised (DCP) procedures - Human (CMDh) response to mitigate the effects of the current pandemic.