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ATMP in the EU - 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, is strictly controlled field in terms of having many regulations and laws established by health authorities with rigid timelines ...

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
Registration of medicinal products – how to choose the right type of application? Anyone, who has even a little experience with pharmaceutical industry, probably knows that the ...

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: EU GMP Non-Compliance Report might lead to FDA Import Stop in future

11.05.2017
The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would ...

GMP: Packaging: Pharmeuropa Draft Chapters regarding PVC

11.05.2017
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of ...

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 ...