AIFA REPORT ON TIMELINES FOR PRICING AND REIMBURSEMENT PROCEDURES IN THE PERIOD 2018-2022
On 27 April 2023, the Italian Medicines Agency (AIFA) published a report on the timelines of “Pricing and Reimbursement” procedures…
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SWITZERLAND AND THE US SIGNED AN MRA RELATING TO PHARMACEUTICAL GOOD MANUFACTURING PRACTICE
Mutual Recognition Agreements (MRAs) are internationally binding agreements between countries that aim to facilitate market access and optimize the use…
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SCIENTIFIC ADVICE TO MANUFACTURERS OF HIGH-RISK MEDICAL DEVICES
EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for all…
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PHARMACOECONOMIC AND BUDGET IMPACT ANALYSES SUBMITTED TO AIFA IN PRICE & REIMBURSEMENT DOSSIERS – REPORT 2022
In accordance with the AIFA Guidelines on the preparation of the Price and Reimbursement (P&R) dossiers, in force since 30…
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ASMF: NEWS ON ASMF SUBMISSION REQUIREMENTS IN ITALY
AIFA has recently published the updated procedures to be followed for the initial submission of an Active Substance Master File…
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SALES REPRESENTATIVES: REGIONAL REQUIREMENTS FOR PROMOTION TO HCPS
In accordance with Legislative Decree 219/2006, medical sales representatives are the only professional profiles that are allowed to promote medicinal…
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STEPWISE PIP: EMA SUPPORT FOR THE AUTHORISATION OF INNOVATIVE MEDICINES
The Paediatric Investigation Plan (PIP), introduced by Regulation (EC) No 1901/2006, is a research and development programme aimed at ensuring…
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THE NEW HTA REGULATION: WHAT IMPLICATIONS FOR PHARMACEUTICAL COMPANIES?
The Regulation (EU) 2021/2282 of the European Parliament and the Council of the European Union on health technology assessment became…
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REORGANIZATION OF THE ETHICS COMMITTEES IN ITALY
The four decrees on the reorganization of the Ethics Committees, which are a further step towards the full implementation in…
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THE REGULATION (EU) NO. 536/2014 IS NOW MANDATORY FOR NEW CLINICAL TRIAL APPLICATIONS
Starting from January 31st, 2023 the new clinical trial applications have to be submitted only through the Clinical Trial Information…
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