REGULATORY AFFAIRS – NEW PLATFORM FOR SCIENTIFIC ADVICE

Starting from October 19th, 2020, developers of human medicines should use the European Medicines Agency (EMA)’s IRIS Regulatory & Scientific…

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MARKET ACCESS – NEW DRAFT GUIDELINES ON PRICING AND REIMBURSEMENT DOSSIERS OF MEDICINAL PRODUCTS

Following the publication of the new Decree relevant to the negotiation of Price and Reimbursement of medicinal products (Decree 2nd…

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MARKET ACCESS – NEW ITALIAN DECREE ON THE PROCEDURES FOR PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS PUBLISHED IN THE ITALIAN OFFICIAL JOURNAL

After almost a year of waiting, the new Decree from the Italian Ministry of Health and the Ministry of Economy…

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MEDICAL DEVICES – TECHNICAL FILE ACCORDING TO MDR REQUIREMENTS – THE IMPORTANCE OF GAP ANALYSES WITH “OLD” DIRECTIVE TECHNICAL FILE

Although the European Commission postponed the entry into force of the Medical Device Regulation until May 2021, this is not…

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MEDICAL DEVICES – SAFETY REPORTING FOR MD CLINICAL INVESTIGATION UNDER MDR

The MDCG has recently issued a new guideline to outline the clinical investigation reporting procedure. According to the guideline the…

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MEDICAL DEVICE – ITALIAN DEROGATION PROCEDURE FOR COMMERCIALIZATION OF NON-CE MARKED DEVICES

The Italian Ministry of Health (MoH) has issued an explanatory note reporting how to place  medical devices not compliant with…

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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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