Blog
Veterinary Medicinal Products Regulation (EU) 2019/6 of the European Parliament and of the Council
28 January 2022
On 28 January 2022, ‘Regulation (EU) 2019/6 of the European Parliament and of the Council, repealing Directive 2001/82/EU’, comes into force. It introduces rules for the authorisation, use and control of veterinary medicinal products. The definition of veterinary medicinal products As defined in Regulation 2019/6, veterinary medicinal products are every substance intended for animals and used for the following purposes: The main objectives […]
The quality data of medicinal products in the registration dossier
19 January 2022
Module 3 is a part of the Common Technical Document (CTD) that contains all the quality data needed to the registration of a human medicinal product. The CTD is a special documentation format used for the submission of registration information of medicinal products to regulatory authorities. In 2003, it became required for all medicinal product submissions in the EU, Japan and recommended in US. It is worth noting that more and more […]
Medical Device Regulation – Regulatory aspects
23 November 2021
You’ve probably heard that after years of discussion, the European Medical Devices Regulation has been reviewed and was adopted on May 2017. Therefore the safety, quality and performance of medical devices destined for the EU market are now subject to new, more rigorous regulations that have entered into force. New regulation on medical devices – key aspects Medical Device Regulation […]
OTC status – what is it all about?
09 November 2021
In general, medicinal products can be bought on prescription or over the counter (OTC). Many products introduced on prescription in the past, now are freely available without it. If you have in the portfolio prescription medicines, maybe it is time to consider whether they could be reclassified. OTC switch could be a time-consuming procedure, not in all cases possible, but worth considering if the safety data about the substance is favorable and […]
ATMP in the EU Guidelines – Regulatory Roadmap
13 October 2021
Advanced Therapy Medicinal Products (ATMPs) represent a fast-growing field of therapies consisting of cellular or genetic components that revolutionize the treatment approach of many previously incurable diseases. This field has attracted significant attention in recent years. Moreover, it is expected that the number of new developed and authorised ATMPs is going to increase significantly over the next few years as a results of the blossoming science in this area. […]
Pharmacovigilance Inspections – Key Points That You Should Know
14 September 2021
Pharmaceutical industry, and more particularly pharmacovigilance process, is strictly controlled field in terms of having many regulations and laws established by health authorities with rigid timelines to follow. To ensure that requirements for monitoring the drug safety are met, it is mandatory for Marketing Authorization Holders’ (MAH) pharmacovigilance systems (PV systems) to be audited by internal and external auditors and also by inspectors from national competent authorities. […]
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 nitrosamine impurities 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 […]