Tag Archives: ema

Entry into force of EU Regulation on Clinical Trials is Getting Closer

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EU Regulations on Clinical Trials number 536/2014 will enter into force 6 months after the publication of a notice by the EU Commission confirming that the clinical trial portal and databases have achieved full functionality in accordance with the required specifications.

Such clinical trial portal and database, where all information submitted through the portal will be stored, supposedly one of the high points of the Regulation, is probably its worst enemy so far. In fact, due to technical difficulties with the development of the IT systems (aka “CTIS”), the portal’s go-live date had to be postponed for years. Therefore, so far, the Directive continues to apply, while some argue that the Regulation – that appeared cutting edge in 2014 – already shows the signs of age.

Now things are finally moving ahead.

On April 21, 2021 the European Medicines Agency’s Extraordinary Management Board confirmed that “CTIS is fully functional and meets the functional specifications, following an independent, successful audit“. 

The ball is now in the European Commission’s court: once the Commission confirms the same conclusions on CTIS, a notice will be published in the Official Journal of the European Union. “Six months after this notice, the Regulation will start to apply and CTIS will go live. The aim is that CTIS goes live on 31 January 2022.” says the EMA.

EMA Committee Recommends Granting Conditional Marketing Authorization to Covid-19 Vaccine

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Today the European Medicines Agency (specifically, its human medicines committee or CHMP) has recommended granting a conditional marketing authorisation to the vaccine developed by BioNTech and Pfizer to prevent COVID-19 in people from 16 years of age.

In the words of the EMA press release, “EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.”

The CHMP has concluded that data on the quality, safety and efficacy of the vaccine are sufficient, given the results of a trial on 44,000 people so far. The process of data collection will in any case continue for at least 2 more years.

It is still unclear who, when and how we will have access to the vaccine, but certainly a vaccine is coming our way. After a 2020 filled with lives lost, fear, confinement and social deprivation, this is absolutely great news. What a few months back seemed wildly optimistic, is now happening.

We want to end 2020 on a high note and wish you relaxing holidays and a new happy, healthy and social year!

G7 Health Summit Closed Today in Milan

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On November 5 and 6 the G7 Ministerial Meeting on Health was held in Milan. The meeting had an ambitious agenda, ranging from the impact of climate change on people’s health to antibiotic resistance.

According to the Italian Ministry of Health, hosting the summit on the occasion of the 2017 Italian G7 presidency, the meeting innovated in the way matters have been examined and discussed, by using a so called Delphi method based on the opinions of the world’s leading experts.

A number of satellite events have also taken place across the city, including a conference organized by police forces to address the cross-border fight against “pharmaceutical crime” in all its forms, identifying the critical factors and common responses. The conference focused on the strategies and international collaborations needed to crack down on counterfeit pharmaceutical products, as well as the import and on-line sales of unauthorized products.

Another satellite event focused on the employment of new technologies in the healthcare sector, with particular emphasis on sustainability. Antibiotic resistance has also been a key item on the agenda. Italy is among the countries in the world where deaths linked to antibiotic resistance are higher.

Italian authorities did not conceal that one of the hidden goals of the summit was for them to lobby for the relocation of the European Medicines Agency- EMA headquarters to Milan. The political battle among candidate cities is about to get more intense, as a decision is expected to be adopted before the end of November.

More information on the agenda and materials of the summit can be found here: http://www.g7italy.it/en.

EMA Issues New Guidelines to Prevent Medication Errors

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On April 14, 2015 the European Medicines Agency (“EMA”) released two drafts of good practice guides aimed at improving the reporting, evaluation and prevention of medication errors. The new guides are addressed to regulatory authorities, as well as the pharmaceutical industry.

Medication errors generally refer to unintended mistakes in the processes of prescribing, dispensing or administering of medicinal products in clinical practice and according to EMA they account for an estimated 18.7 – 56% of all adverse drug events among hospitalized patients.

The first guide released by EMA provides an overview of the main sources and types of medication errors, as well as measures to minimize the risks that such errors are made. The second guide, on the other hand, focuses on suspected adverse reactions caused by medication errors, providing guidance and recommendations on how to record, code, report and assess such errors.

The guidelines from EMA recommend a number of actions to marketing authorization holders, including the periodical reporting of information concerning medication errors. Recommendations to the industry include periodical safety update reports and risk management plans to be adopted for each marketed pharmaceutical product. The overall scope of these reporting obligations is to implement a real-life continuous evaluation of the risks and benefits of all medicines placed on the European market.

The two draft guidelines are now open to comments from all relevant stakeholders: the public consultation procedure will expire on June 14, 2015. The final version of the guidelines is expected to be finally adopted later in 2015.

More information and the new draft guides can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002307.jsp&mid=WC0b01ac058004d5c1.