Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 02 August 2012 | By Louise Zornoza,
The European Medicines Agency (EMA) is phasing out so-called "follow-up measures" for human drugs requiring post-marketing studies this month, instead replacing them with three categories of post-marketing commitments:
The old "follow-up measures" established studies and other activities that the European Medicines Agency and the Committee for Human Medicinal Products had asked the marketing authorization holder to perform.
This new system of classification is being implemented in stages. The first phase tackled initial marketing-authorization-application opinions as of June 2011, followed by post-authorization procedures starting in November 2011. Companies affected by the new classification changes will receive an outcome fax for each applicable product that will include information about the new classification of follow-up measures, together with any actions that they need to take.
EMA - European Medicines Agency phasing out follow-up measures
Read more Breaking News from RegLink
Tags: Follow-up Measures, Postmarketing Commitments, Phase IV, MAA, Latest News, marketing, MAH
Regulatory Focus newsletters
All the biggest regulatory news and happenings.