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What is the appropriate classification of disinfectants?

In this difficult time of health emergency linked to the spreading of the COVID-19 virus, the demand of disinfectant products is becoming...

Covid-9 emergency: the European Commission works on proposal to postpone Reg. (EU) 2017/745 application of one year

On 25 Mach 2020, in full Covid-19 emergency, a note was released by the European Commission where they announced they...

Art. 5(3) Referral on Nitrosamines

Last September EMA opened an Art.5(3) Referral to request the risk assessment of the presence of impurities (nitrosamines) in drugs for human...

Respiratory protection in the time of covid-19: ppes, mds and the latest developments in the national regulatory framework

The most used personal protection equipment (PPE) for respiratory protection is filtrating masks. These are usually bound to meet the requirements of the technical...

Update on the measures adopted by Di Renzo Regulatory Affairs in compliance with the provisions to contrast the spreading of the COVDI-19 epidemic

In compliance with the provisions of the President of the Ministry Council in order to contain the spreading of the...

What regulations say about drug shortage

Recent news say that Competent authorities for medicinal products in Europe and United States are preparing themselves to face one...

The lifecycle of vaccines, from development to post-marketing vigilance

The word “vaccine” is now very much recurring in the daily news; it is important, then, to understand the steps...

COVID-19 emergency: AIFA creates “Coronavirus crisis unit”

Discussions with the technical scientific Committee on investigational drugs and off-label use The crisis unit created by AIFA for the...

Devices like drugs, what will change with the UDI code

The application of the new Regulation EU 2017/745 o medical devices was postponed of one year, but some of the...

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