The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations. "The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes. Specifically, the updates include a new pre-submission c...

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database. The database, referred to as the EU PAS Register (European Union electronic register of post-authorisation studies), is operated by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), and was established with the aim of increasing transparency for post-authorisation studies. The EU Pass Regi...

The European Medicines Agency (EMA) today issued draft scientific guidance intended to help sponsors design post-authorization efficacy studies (PAES). The guidance, which comes a year after a new regulation, known as the Commission Delegated Regulation (EU) No 357/2014, established circumstances in which EU regulators could require PAES for all medicines. In the past, PAES were typically only required for medicines approved conditionally or under exceptional circumstanc...

Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU. The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2) , which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1) , which takes effect on 12 August 2015. Background Pharmacovigilance is the process of monitoring the use...

User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...

The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure. EMA's 18 April revision of the Q&A document represents its 21 st revision, and is a comprehensive resource including information from a wide range of regulations and guidances. "This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization procedures," ex...