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...
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EMA - Agendas and minutes


Agendas and minutes

Minutes - PDCO minutes of the 12-15 December 2017 meeting

Minutes for the meeting on 12-15 December 2017

Agenda: Agenda - European Medicines Agency veterinary medicines innovation...

The objective of this meeting is to further raise awareness of the support available to facilitate innovation of veterinary medicines by giving an overview of the legislative framework and by...
EMA - What's New


Scientific guideline: Reflection paper on physical frailty: instruments for...

This document is intended to describe the recommended instruments for the characterization of the baseline physical frailty status of older patients (i.e. aged ≥ 65 years) enrolled in a clinical...
EMA - Events


Events

European Medicines Agency veterinary medicines innovation day, European Medicines Agency,...

The purpose of the European Medicines Agency (EMA) veterinary medicines innovation day is to raise awareness and promote the support and measures that the Agency has to offer in the...

Update on Brexit regulatory preparedness activities for veterinary companies ,...

The European Medicines Agency (EMA) is holding this meeting to give an update on EMA Brexit preparedness activities and address any specific questions industry stakeholders may have further to the...

Twelfth industry stakeholder platform on the operation of pharmacovigilance in...

The twelfth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system.
EMA - News and press releases


News and press releases

News and press releases: Committee for Medicinal Products for...

CVMP recommends changes to product information for some veterinary medicines containing enrofloxacin, to reduce development of antimicrobial resistance in target pathogens

News and press releases: Veterinary medicines: highlights of 2017

18 medicines recommended for marketing authorisation, including ten vaccines

News and press releases: Regulatory information – adjusted fees...

Pharmacovigilance fees increase by 1.4%
EMA - Public consultations


Ongoing public consultations

Regulatory and procedural guideline: Qualification opinion - The European...

This report provides a draft context of use for public consultation describing where this registry is deemed by CHMP as an appropriate data source for post-authorisation studies to support regulatory...

Scientific guideline: Draft guideline on clinical investigation of medicinal...

Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with...

Scientific guideline: Draft guideline on safety and efficacy follow-up...

This guideline replaces the guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products (EMEA/149995/2008)
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...