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

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?

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?

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

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

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

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

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: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017)

EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials.
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The ...

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

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 ...

EMA: New guide on biosimilar medicines for healthcare professionals

The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that ...

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