THE MAIN INNOVATIONS OF THE EUROPEAN REGULATION 745/2017

In about one year the new European regulation on medical devices, European Regulation 745/2017, will be reality and the new…

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EUROPEAN REGULATION 2017/745 – Clinical evaluation: new requirements for equivalence demonstration

The European regulation 2017/745, that will entry into force in May 2020, introduces several new elements with an impact on…

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“Pharma disclosure”: EFPIA’s Code on Transfers of Value

Starting from 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies made public the details of payments and…

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MEDICAL DEVICES – European Regulation 2017/745 – What happens to CE certificates obtained in compliance with the “old directive” 93/42/EEC?

The entry into force of the new regulation is now close. From 26 May 2020 it will no longer be…

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The management of the clinical trial in Italy after the Brexit

  On 29 March 2017 The United Kingdom notified its intention to withdraw from the European Union.  Thus, unless there…

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Optimising Orphan Drug Development in the EU

  The legislative framework on orphan medicinal products aims at stimulating research and development of medicinal products for rare diseases…

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Changes to the procedure for the request of access to the “AIFA 5% fund”

Changes have recently been introduced by AIFA concerning the procedure for the request of access to the so-called “AIFA 5%…

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REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION

After the Decision No. 78 of the Board Eurasian Economic Commission (EEC) oN November 3rd, 2016, the “Rules” for registration…

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AIFA – SALES REPRESENTATIVE DATA TRANSMISSION

We are getting close to the deadline relevant to the annual transmission to AIFA of the sales representative data. Every year,…

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AIFA – PRICE INCREASE OF CLASS C MEDICINAL PRODUCTS SUBJECT TO MEDICAL PRESCRIPTION

AIFA has recently circulated on its website the communication about the price increase of Class C medicinal products subject to…

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