Pharmaceutical News and Updates

Clinical trial portal in Europe

The EMA Board has endorsed the functional specifications for a clinical trial portal and database that will be developed by the EMA as part of the implementation of the new EU Clinical Trials Regulation. These specifications were drawn up by the EMA in collaboration with the Member States and the…

Revised patient interaction framework

The Management Board has adopted a revised framework for the EMA’s interaction with patients, consumers and their representative organisations. One of the goals is to incorporate patients’ and consumers’ values and preferences in all evaluation activities, to further ensure the safe and rational use of medicines. Consulting with and listening…

New EMA framework to enhance patient interaction

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…

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…

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…

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…