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OTC status – what is it all about?

09.11.2021
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 ...

ATMP in the EU Guidelines - Regulatory Roadmap

13.10.2021
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 ...

Pharmacovigilance Inspections - Key Points That You Should Know

14.09.2021
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 ...

How CMDh helps Marketing Authorisation Holders to facilitate regulatory procedures during the COVID-19 crisis?

17.08.2021
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 ...

Registration of medicinal products – how to choose the right type of application?

02.07.2021
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 ...

Why is pharmacovigilance needed in your company?

30.06.2021
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 ...

Are nitrosamines still a concern for a drug product?

09.06.2021
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, ...

GMP: GCP: EMA Draft Guideline relating to the Trial Master File

11.05.2017
In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, ...

RAPS: FDA Offers its Views on Medical Device Trials

11.05.2017
Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array ...

RAPS: Biosimilars in the EU: New IMS Report Shows Savings Through Competition

11.05.2017
A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.The ...