MARKET ACCESS – SIHTA POSITION PAPER
The Italian HTA Society (SIHTA) has recently published a Position Paper which aims at indicating a possible evolution of the…
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QUALITY ASSURANCE – QUALITY SYSTEM & REMOTE AUDITS DURING COVID-19 EMERGENCY
On 11th March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. Covid-19 Emergency has put a…
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MARKET ACCESS – AIFA GUIDELINE FOR THE DEVELOPMENT OF PHARMACOECONOMIC ANALYSIS AND MODELLING IN SUPPORT OF THE P&R DOSSIER
The Italian HTA Agency (AIFA) has published the first guideline in order to harmonize the structure and the requirements for…
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MARKET ACCESS – UPDATED CRITERIA FOR THE INCREASE OF PRICES OF MEDICINAL PRODUCTS REIMBURSED BY THE ITALIAN NHS
An update for the increase of prices of medicinal products reimbursed by the Italian NHS has recently been provided by…
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REGULATORY AFFAIRS – COVID-19: EMA INITIATIVES
Due to the current COVID-19 pandemic, EMA has taken lots of initiatives (EMA/213341/2020) to accelerate the development support and evaluation…
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MEDICAL DEVICES – HOW TO SET UP CLINICAL EVALUATION IN COMPLIANCE WITH THE REGULATION (EU) 2017/745 FOR MEDICAL DEVICES ALREADY MARKETED UNDER DIRECTIVES 93/42/EEC OR 90/385/EEC
To confirm the compliance with the General Safety and Performance Requirements (GSPR) of the MDR, a clinical evaluation shall be…
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MEDICAL DEVICE – REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES IN PILLS
Considering the COVID-19 pandemic there is a huge and increasing need of ventilators to be used in particular with most…
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MEDICAL DEVICES and PERSONAL PROTECTIVE EQUIPMENT – NON-COMPLIANT CE CERTIFICATES AND HOW TO RECOGNISE THEM
In order to be placed on the European Market, a medical device (MD) shall comply with one of the relevant…
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MEDICAL DEVICES – PROTECTIVE MASKS: REGULATORY REQUIREMENTS IN PILLS
Considering the COVID-19 pandemic there is a huge and increasing need of protective devices, protective masks in particular. Protective masks…
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REGULATORY AFFAIRS – EXPECTATIONS DURING COVID-19: RENEWALS AND “SUNSET CLAUSE”
The Q&A developed by European Commission, EMA and the European medicines regulatory network provides guidance to companies on adaptations to…
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