EMA Publishes Annual Report - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Publishes Annual Report


The European Medicines Agency (EMA) released its annual report detailing drug approvals and agency projects completed in 2013, as well as initiatives started in the past year. According to the report, EMA recommended 81 drugs for marketing authorization in 2013, up from 57 in 2012. There was also an increase in the number of drugs containing new active substance; however, the number of generic drugs remained stable. EMA also recommended two new advance-therapy drugs in 2013 and approved 11 orphan drugs.

The report also highlights projects, initiatives, and achievements made by the agency in 2013 including access to clinical trial data as part of a marketing authorization application, advancement in patient access to medicine, reorganization of the agency, and implementation of new legislation. The report also details the agency’s pharmacovigilance activities as part of implementation of the European Union’s pharmacovigilance legislation.

Source: European Medicines Agency

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
10%
Provide treatment for patients globally.
6%
All of the above.
42%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Click here