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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups

The European Medicines Agency (EMA) has published the list of active substances and a reference to the journals that will be covered by its new medical literature monitoring service. This service will start with a limited number of active substances on 1 July 2015 and will be fully rolled out in September 2015. A guide, a training video and a document detailing the inclusion and exclusion criteria to be used when screening the literature are also available on a dedicated webpage.

Medical literature is an important source of information on suspected adverse reactions reported on medicines. The European Union's (EU) pharmacovigilance legislation has given EMA responsibility for the monitoring of selected medical literature for a defined list of active substances used in medicines and for entering identified reports of suspected adverse reactions in EudraVigilanceExternal link icon, the EU adverse drug reaction collection and management system.

This initiative aims to improve the safety monitoring of medicines by enhancing the quality and consistency of data reported in EudraVigilance. It is provided as a service to industry which, for the active substances and literature covered by the EMA activities, will no longer be obliged to enter the information on suspected adverse reactions into EudraVigilance. Individual cases of suspected adverse reactions found in the literature will be made available to marketing-authorisation holders so they can include them in their safety databases and meet their reporting obligations outside the European Economic Area.

A total of 400 active substance groups will be monitored by EMA, in particular substances that are contained in a high number of medicinal products, and over 4,000 companies will benefit.

Following a public procurement procedure, EMA has selected a contractor to support the Agency in the operation of this service.

Companies should consult the documents published today to find out whether their products are included in the service.

As of 1 July 2015, the service will cover the top 50 chemical active substance groups (ID 1 to ID 50) which are listed in the document published today. Companies with medicines containing one of these active substances will benefit from the EMA service from 1 July and will need to adapt their processes by that date. All the other substances, including the herbal active substances that are listed, will be included in the EMA service as of September 2015.

EMA will send updates on the implementation of its medical literature monitoring service to the qualified persons for pharmacovigilance as well as to pharmaceutical industry organisations.