During its 2-day meeting in December, the European Medicines Agency (EMA) Management Board adopted the agency’s work programme and budget for 2015 and a preliminary draft programme for 2016. The priorities for human medicines over the next 2 years include: • ensuring that assessment activities are conducted to the highest standards of quality and regulatory [read more…]
Archive for the ‘Pharmaceutical News’ Category
New international standard to improve safety of medicines
New EMA guide will help industry and regulatory authorities to implement changes The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines [read more…]
Changes in timelines with Scientific Advice Procedure
As of 17 November 2014, the European Medicines Agency is introducing changes to the procedures for scientific advice, parallel advice with health technology assessment (HTA) bodies, protocol assistance and qualification of novel methodologies. These changes are expected to further streamline the timetables and will apply to applications starting in January 2015 onwards. These changes [read more…]
More on Adaptive Licensing (AL)
There is currently much debate about adaptive pathways for new medicinal products to come to the market. The terms ’staggered approval’, ’progressive licensing’, and ’adaptive licensing’ have been used, often interchangeably, to describe the same broad concept. More recently, the term ‘Medicines Adaptive Pathways’ (MAPs) or ‘Medicines Adaptive Pathways to Patients’ (MAPPs) is discussed [read more…]
Adaptive Licensing
A Brief Summary of the new fast-track European procedure by Simon Ruini, Director of PhD London The Adaptive Licensing Pilot Project was launched by the EMA on 19 March 2014. This summary addresses some frequently asked questions and clarifies the terms of engagement and expected outputs for prospective applicants. 1. What is Adaptive Licensing and what does [read more…]
Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines
From today, the European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation. This includes completing previously submitted information with additional data elements included in the new data-submission format, bringing medicine information up–to-date, and checking that the [read more…]