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Following the recent withdrawals of many blockbuster drugs, Pharmacovigilance has become a critical phase in the Clinical Development Programs of pharmaceutical companies. The regulations on safety monitoring have become stringent and are periodically revised. This has led to increased safety data collection, analysis and regulatory surveillance, which in turn has increased costs. You, therefore, need a strategic partner with process expertise–one who can minimize your cost pressures while unlocking value and maintaining compliance
The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfil the stringent obligations. Covalent tech Pharmacovigilance team is comprised of Medical & healthcare professionals with vast experience in both direct patient care and industry-specific Pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services.
The EVMPD has been developed by the European Medicines Agency in collaboration with the EudraVigilance implementation fora. The main objective of the EVMPD was to assist the pharmacovigilance activities in the European Economic Area (EEA). As such, the EVMPD was designed to support the collection, reporting, coding and evaluation of authorised and investigational medicinal product information in a standardised and structured way.
In December 2010 new pharmacovigilance legislation amending existing legislation was adopted in the European Union (EU) resulting in the need to update the EVMPD in accordance with the format for of the electronic submission of information on medicines published by the Agency on 1 July 2011. Based on the new format, the EVMPD has been re-branded as Extended Medicinal Product Dictionary (XEVMPD), enabling the Agency to:
An update arrived from EMA on 7thNovember with some new guidance. At first glance it looks pretty innocuous: just a few files labelled “Controlled vocabularies quality control” and the typical updated vocabulary files:
EMA is preparing ground for handling variations – “Invalidate MA” code is introduced to facilitate change in market authorization holder, renew an authorization, and even a code for variations. However, for variations it is specifically listed as not usable until new guidance is issued. So at least you can sell a product to another company, and update for renewals.
With a new field is being added, there will be a new XML schema (which has not yet been released): Previous EV codes can now be used to refer to previous authorized products and development products. That means that the schema has to support both a development and authorized EV code – a choice in the XML schema.
The controlled vocabularies for substances, dosage forms and routes of administrations are being cleaned up. As a result everything will need to be resubmitted again between June and November of 2014.
On 11 June 2011, the Commission published in the Official Journal (OJ 2011/C 172/01) a Communication on the detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’).
In this context sponsors should provide, before completing the clinical trials application form, information on the Investigational Medicinal Product (IMP) in the Extended EudraVigilance Investigational Medicinal Product Dictionary (‘XEVIMPD’).
This is expected to be put into place late 2015 or early 2016 keep watching this space for more updates.