Blog
How CMDh helps Marketing Authorisation Holders to facilitate regulatory procedures during the COVID-19 crisis?
17 August 2021
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 […]
Registration of medicinal products – how to choose the right type of application?
02 July 2021
Anyone, who has even a little experience with pharmaceutical industry, probably knows that the development and registration of medicinal products is a complex, expensive and time-consuming process. One of the main sources of expenses and risks in this endeavour are clinical trials. High costs of clinical trials are well known – according to Wouters et al. (2020) [1] clinical development of medicinal product may cost […]
Why is pharmacovigilance needed in your company?
30 June 2021
If you run a pharmaceutical company with the investigational or authorised medicinal products you must have heard about pharmacovigilance (PV). As legal obligation is imposed on any Marketing Authorisation Holder (MAH), continuous actions of pharmacovigilance process are required to ensure products’ safety. So why is pharmacovigilance process so important and how can we help you? Pharmacovigilance is a key element of drug lifecycle Indeed it is, since Pharmacovigilance activities are required […]
Are nitrosamines still a concern for a drug product?
18 June 2021
In June 2018 it was recognized that some active substances used in manufacturing of medicinal product contained undesired levels of potentially carcinogenic nitrosamine impurities (e.g. NDMA, NDEA). Immediately afterwards, EU regulators started to establish ways of minimizing that risk. As a result, MAHs were requested to review their manufacturing process and evaluate the risk of the presence and possible sources and formation of nitrosamine impurities in their medicinal […]