EMA Consultation: Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products – Revision 1

The European Medicines Agency has released for public consultation a draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products – Revision 1.

The aim of this guideline is to provide the guidance for the Safety and Efficacy (S&E) follow-up and risk management for advanced therapy medicinal products (ATMPs) according to Article 14(4) of Regulation (EC) No 1394/2007. This regulation requires the European Medicines Agency (EMA) to develop a detailed guideline relating to the post-authorisation follow-up of efficacy and adverse reactions, and risk management for these products.

This is the 1st revision of the original ATMP guideline on safety and efficacy follow-up and risk management; the guideline has been revised to take into consideration the experience gained with the authorisation of these products and to define their risks and their risk minimisations measures. In addition, guidance on methodology in order to design post-authorisation S&E follow-up studies is provided.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to atmpguideline@ema.europa.eu by 30/04/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations.

For more information, see Specific privacy statement for public consultations here.

For more information on the European regulatory system for medicines, please consult our brochure.

Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities

Companies that make sartan blood pressure medicines (also known as angiotensin II receptor blockers) are being required to review their manufacturing processes so that they do not produce nitrosamine impurities.

These recommendations follow EMA’s review of N-nitrosodimethylamine (NDMA) and N‑nitrosodiethylamine (NDEA), which are classified as probable human carcinogens (substances that could cause cancer) and have been detected in some sartan medicines.

For the vast majority of sartan medicines, impurities were either not found or were present at very low levels.

The review estimated the highest possible cancer risk with these impurities. It concluded that if 100,000 patients took valsartan from Zhejiang Huahai<https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity-some> (where the highest levels of impurities were found) every day for 6 years at the highest dose, there could be 22 extra cases of cancer due to NDMA over the lifetimes of those 100,000 patients. NDEA in these medicines could lead to 8 extra cases in 100,000 patients taking the medicine at the highest dose every day for 4 years.[1] The estimates have been extrapolated from animal studies and are very low compared with the lifetime risk of cancer in the EU (1 in 2).

Further information, including specific information for patients and healthcare professionals, is available by clicking here.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

Omega-3 fatty acid medicines no longer considered effective in preventing heart disease

EMA has concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack. The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use.
Omega-3 fatty acid medicines have been authorised for use after a heart attack, in combination with other medicines, in several EU countries since 2000, at a dose of 1 g per day. At the time of their authorisation, available data showed some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest. Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use.
Although there are no new safety concerns, EMA’s human medicines committee (CHMP) concluded that the balance between the benefits and risks of these medicines to prevent recurrence of heart disease or stroke is now negative.
These medicines can still be used to reduce levels of certain types of blood fat called triglycerides.
Further information, including specific information for patients and healthcare professionals, is available by clicking here<https://www.ema.europa.eu/en/medicines/human/referrals/omega-3-fatty-acid-medicines>. For more information on the European regulatory system for medicines, please click here<https://www.ema.europa.eu/about-us/how-we-work/european-medicines-regulatory-network> (brochure available in all languages).

EMA launches new corporate website

The European Medicines Agency (EMA) has launched a new version of its corporate website today: https://www.ema.europa.eu/en/news/ema-launches-new-corporate-website

The website has a number of new features to improve user experience, including:

  • an improved search, allowing users to find content easily and to filter their search results. EMA plans to further refine this functionality in the future;
  • a ‘responsive’ design for cleaner display on mobile devices;
  • a simpler URLs based on the location and title of webpages or documents;
  • an updated visual design offering users a clearer reading experience and simpler navigation.

The website’s content and structure remain unchanged. Although the site’s URLs are new, URLs from the previous website will continue to work for every page and document, thanks to one-to-one redirects. Although these redirects will be available for an indefinite period, EMA encourages users who have bookmarked any URLs to consider updating them at their convenience now that the new site is live.

The new website has been designed to work optimally on the latest web browsers. EMA carried out the project to relaunch the website in collaboration with the European Commission’s Directorate General for Informatics (DIGIT).

DIGIT will also host and maintain the new website on behalf of EMA.

To provide general feedback on the new EMA’s corporate website or to make suggestions for future improvement, please write to newwebsite@ema.europa.eu. EMA will take all feedback and suggestions into account, but will not be able to reply to individual email messages.