MARKET ACCESS – EXPLANATORY NOTE ON COMPASSIONATE USE REGARDING TREATMENT OF COVID-19

Following the legislative decree n.18 of 17 March 2020, AIFA published an explanatory note on Compassionate Use regarding treatment of…

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REGULATORY AFFAIRS – RISK EVALUATION ON NITROSAMINES STEP 1 – EXTENDED TO 1 OCTOBER 2020

Due to the severe impact of COVID-19 pandemic, the European Medicines Regulatory Network has agreed to extend the deadline to…

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REGULATORY PROCEDURES – SOLUTION on eCTD PUBLISHING AND SUMBISSIONS

Under Covid-19 emergency your company can face several challenges due the mandatory lockdown in place, and you may need a…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – Class I transitional provisions under article 120 (3 and 4): Declaration of Conformity Requirements

With the II Corrigendum of the Regulation 2017/745, the transitional provisions of the Article 120 (point 3 and 4) of…

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MEDICAL DEVICES – EUROPEAN COMMISSION DISCUSSING ON POSTPONING MDR APPLICATION

The current COVID-19 pandemic is quickly changing everything all around the world and healthcare systems are experiencing an extreme pressure…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – NEW PROCEDURE FOR THE AUTHORIZATION OF USE IN DEROGATION OF THE FACIAL PROTECTIVE DEVICE WITH A MEDICAL INTENDED PURPOSE

In order to better manage the emergency due to the COVID-19 and ensure the supply of protective device against the…

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CLINICAL TRIALS – “DECRETO CURA ITALIA” (LEGISLATIVE DECREE N.18 OF 17/03/2020): CLINICAL TRIALS AND COMPASSIONATE USES FOR THE TREATMENT OF PATIENTS AFFECTED BY COVID-19

In the article 17 of the Legislative decree n.18 published on 17/03/2020, the Italian government provides indications on the management…

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MARKET ACCESS – TRANSITIONAL MEASURES RELATING TO THE EXTENSION OF AIFA MONITORING REGISTERS AND THERAPEUTIC PLANS DURING COVID-19 EMERGENCY

Considering the current epidemiological emergency from Covid-19, the Italian Medicines Agency AIFA has communicated some transitional provisions related to monitoring…

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CLINICAL TRIALS – MANAGEMENT IN ITALY DURING THE COVID-19 EMERGENCY

The Italian Medicines Agency (AIFA) has provided the following specific indications for the management of clinical trials in Italy during…

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MEDICAL DEVICES – MDR: UPDATES ON DESIGNATION STATUS OF NOTIFIED BODIES

Although experts focus mainly of the impact of the Regulation (EU) 2017/745 (MDR) on the activities of companies involved in…

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