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Handbook: revision under way, space for the innovative

On 12 and 13 February, with the meeting of the technical-scientific committee of the Italian Medicines Agency, the first revision examination of the pharmaceutical handbook will start which must be concluded, as required by the Balduzzi law, by 30 June next. The revision of the list of drugs, available within the national health service, takes place after 19 years: the last one was carried out in 1994, even if a working group had already been started by Guido Rasi, Luca Pani's predecessor at the Aifa management. An indication on the address to which to direct the new document comes from the Minister of Health, Renato Balduzzi who, on the occasion of a conference at the US embassy in Rome, affirmed the need "not to stop innovation, but everything that is not" and to make a selective choice that excludes "falsely new" drugs in favor of innovative and more useful molecules. "We must win together, institutions and companies" underlined the minister "the battle for innovation". A theme at the center of the intervention of Luke Pani: «There are 37 innovative drugs, including the first gene therapy, approved by the Food and Drug Administration in the last 12 months» underlined the AIFA director. "Since 1997, there have never been so many registered, with an increase of 40% compared to the registrations of the last two years." These medicines are already under examination by European agencies and soon, added the director general of AIFA, they may be available in Europe, but with different registration times compared to the USA, given that Europe has "slightly longer procedures, which however are a guarantee for patient safety".

6 February 2013 – DoctorNews33


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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco