PHARMACOVIGILANCE

Serious side effects force a third of diabetics to quit...

  The side effects of the world's most commonly-prescribed diabetes drug are so severe that around a third of patients stop taking it, a new study has...

Half of over-65s taking five or more prescription drugs a...

Half the population of over-65s is taking at least five different prescription drugs every day, and some are taking as many as 23, a new study has discovered. The...

Regulator hid dangers of epilepsy drug for 40 years

    Drug regulators knew an epilepsy drug could cause birth abnormalities if a woman took it while she was pregnant, but didn't alert the public...

Young women still being prescribed thalidomide

Thalidomide, the morning sickness drug that caused appalling birth defects in more than 10,000 babies in the 1960s, is still being prescribed to young women who become pregnant—and three women...

Someone takes a drug wrongly every 21 seconds (that's 10.5...

Pharmaceuticals are dangerous enough as it is—but when they're taken incorrectly, they can be lethal. It's a common problem, with someone in the US reporting a serious medication error every...

Depression overdiagnosed by questionnaire developed by drug company

People are being diagnosed with depression with a simplistic point-scoring questionnaire that was developed by the drug company that has some of the leading antidepressant brands, and so is most...

One in three new drugs have serious—and sometimes deadly—safety issues

There's something seriously wrong with our drug approval processes. One in three drugs that pass all the usual checks before being given a licence are unsafe, and are causing serious—and...

New drugs aren't being properly tested for their safety or...

New 'breakthrough' drugs are often being allowed onto the market as safe and effective treatments with minimal evidence—and drug companies are failing to provide any good research even five years...

Statins raise type 2 diabetes risk by 60 per cent

  Cholesterol-lowering statins do raise the risk of type 2 diabetes, a major new review has confirmed. The risk can rise by as much as 60 per...
Indietro12Avanti
EMA - Agendas and minutes


Agendas and minutes

Minutes of the CHMP meeting 23-26 April 2018

Committee for medicinal products for human use (CHMP) minutes of the meeting on 23-26 April 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal...

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance...

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal...

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance...
EMA - What's New


Regulatory and procedural guideline: EudraVigilance release notes v.1.15

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.
EMA - Events


Events

The new EudraVigilance system and the electronic reporting of ICSRs...

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format....

The new EudraVigilance system and the electronic reporting of ICSRs...

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format....

The new EudraVigilance system and the electronic reporting of ICSRs...

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format....
EMA - News and press releases


News and press releases

News and press releases: Meeting highlights from the Pharmacovigilance...

PRAC held public hearing on quinolone and fluoroquinolone antibiotics

News and press releases: IT systems unavailable from 15...

EMA website and online applications will be temporarily unavailable

News and press releases: Highlights of 100th Management Board...

Positive assessment of 2017 operations - Seat Agreement with the Netherlands signed
EMA - Public consultations


Ongoing public consultations

Scientific guideline: Concept paper on preparation of a revised...

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is...

Scientific guideline: Draft guideline on the responsibilities of the...

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas...
EMA - Vacancies


Vacancies

Discontinuation of vacancies RSS feed - visit our Careers section

Please note that from January 2018, EMA will publish vacancy notices on its [email protected] portal and will no longer update this vacancies RSS feed. For more information, please click on...