Published by MHRA on 09-Apr-2014 Individual case study reports (ICSRs) are being wrongly expedited to the MHRA as spontaneous cases. The guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products; section…
Published by EMA on 11-Mar-2014 The European Medicines Agency has published the first summary for the public of the risk-management plan (RMP) of a newly authorised medicine. This RMP summary, which concerns the medicine Neuraceq, describes what is known and not known about…
Published by EMA on 10-Feb-2014 Following the receipt of the requested information from the marketing authorisation holders, the Agency has re-allocated the ownership of the organisation entities previously created and owned by the Agency to the owner organisations as identified…
Published by EMA on 19-Feb-2014 The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on pharmacovigilance (medicine safety) topics. Building on the experience of previous regular videoconferences between the EMA and the FDA in…
Published by EMA on 31-Jan-2014 Over 40% of innovative medicines recommended for marketing authorisation in the European Union (EU) between 2010 and 2012 originated from small or medium-sized enterprises (SMEs), academia, public bodies and public-private partnerships, according to an article published today…
EMA publishes an updated List of Medicinal Products under Additional Monitoring (Rev 8, 29-Jan-2014) The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. Medicines under…
Some of the Pharmacovigilance-related Guidances planned to be Published in 2014 (New & Revised) Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Providing Regulatory Submissions in Electronic Format – Postmarketing Safety Reports Adverse Events: Collection and…
The MHRA risk-based inspection process uses information provided to the MHRA on a Compliance Report which is to be completed every 2 years. The resulting risk assessments are ranked and inspections prioritised for the companies with the highest risk assessment scores.…