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4 Apr 19
A joint HMA and EMA taskforce analyzes the use of big data for the evaluation and monitoring of medicines
The Joint Big Data taskforce (“Taskforce”) between the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) was formed to describe the big data landscape from a regulatory perspective in order to ensure that the EU regulatory system has the capability and capacity to guide, analyze and interpret this data. Its work aims to facilitate the use of such data for the process of evaluation and monitoring of medicines by the regulatory authorities, analyzing the risk-benefit of medicinal products during their lifetime.
2 Apr 19
Patient disease registries: potential use for regulatory purposes
Public consultation on the discussion paper published by the European Medicines Agency (EMA) regarding the crucial role of patient disease registries in monitoring the safety of medicines is open until June 30, 2019.
New safety features for most prescription medicines and some OTC medicines supplied in the EU
6 Feb 19
No deal brexit’s impact on the pharmaceutical and medical devices industries: guidance from the ema and the european commission
On January 15, 2019, the UK House of Commons rejected the withdrawal agreement reached by Theresa May and the EU after a long and exhausting negotiation period of almost 2 years.
EMA has launched a public consultation on key principles for the electronic product information of EU medicines
2 Dec 17
Product information: EMA starts digitization
The European Medicines Agency (EMA) gives the go-ahead for digitization in terms of product information.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-Healthcare industry.
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Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and Venture Capital transactions.

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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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