Pharmaceutical News and Updates
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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Monitoring of Patent Settlements in Europe
Patent settlement agreements are commercial agreements to settle patent-related disputes, e.g. questions of patent infringement or patent validity. They are concluded in the context of patent disputes, opposition procedures or litigation where no final…
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End of Herbal Sell-through Period
The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding herbal companies and retailers that, as of 1st May 2014, unlicensed manufactured herbal medicines without a traditional herbal registration (THR) or product licence (PL)…