Other News

Update on Brexit developments

These days there doesn’t seem to be a day that goes by where there isn’t some snippet of news on the great Brexit plan. Obviously, something of such magnitude has ramifications across all sectors of life. Naturally the regulatory aspects of drug registration and life cycle management are areas that will require very careful planning and implementation, as well as constant revision of such plans as more clarity is fed down from the EMA. What we know thus far is that on the 20th November the EMA has decided to relocate its offices from London to Amsterdam.  The move has to be executed by 30 March 2019 at the latest, and there will be expected bumps along the way regarding transition. This recent development has been followed up by two new documents; firstly, the EMA has released updated procedural guidance on Brexit-related changes. This guidance includes how to classify variations, what supporting documents are required and whether variations can be grouped, as well as many more items. Subsequent to this, the EMA has just released an updated Q&A document giving organisations further guidance related to Brexit submissions - specifically covering situations where the UK is part of the MA registration in various aspects, such as API, batch release, QPPV, MAH and so on.

As the clock is ticking for Brexit, ELC Group has been working closely with its clients in helping to prepare and plan for all Brexit-related changes.  There are only 16 months remaining and the regulatory landscape is expected to develop further, so it is imperative that a robust regulatory impact analysis is undertaken on your product portfolio. ELC Group can be your partner of choice whether that is acting as local QPPV, or as MAH or Batch release site, looking for a new API supplier or FP manufacturer, or an update to your PSMF.  Our office location in Prague means we will still be part of the EU27 and, with our extensive network of EU partners, we offer an ideal solution for your pre- and post-Brexit needs.

Also see our

press coverage

News Index

15 Dec 2017

Update on Brexit developments

05 Oct 2017

How recent moves by the FDA spell good news for generics in the US

11 Sep 2017

Medicines for the Elderly – is your drug development strategy up to the mark?

14 Aug 2017

The MNAT initiative – what’s new?

19 Jul 2017

ICH Q12: Light at the end of the tunnel…?

05 Jun 2017

Q3D: Are your established products in compliance?

02 Jun 2017

Key pharmacovigilance trends to watch

08 May 2017

EMA updates guidance on PSURs

10 Apr 2017

New EMA Consultation on the Quality of Inhaled Pharmaceutical Products

16 Mar 2017

European Parliament’s adoption of ‘Options for improving access to medicines’ procedure

16 Feb 2017

Article 58: a hidden potential

24 Jan 2017

Global lifesciences partner ELC Group teams with PSR Group for advanced drug development

19 Jan 2017

A positive step forward for Biosimilar registration

20 Dec 2016

Falsified Medicines Directive – Are you making the right preparations?

21 Nov 2016

New Public consultation launched by the European Commission (EC)

19 Oct 2016

Transatlantic collaboration to boost research and development of medicines for rare diseases

03 Jun 2016

ELC Group to showcase regulatory affairs solutions at CPhI events in Shanghai and Barcelona

16 Jun 2015

ELC Group in early-stage development of novel influenza vaccine

09 Jun 2015

ELC Group expands into pharmaceutical product development market

21 Apr 2015

ELC Group signs 1.5 million Euro regulatory affairs contract with Chinese pharma giant

24 Feb 2015

Fast-growing regulatory affairs service provider ELC Group expands corporate presence in Czech Republic

02 Feb 2015

ELC GROUP to present at “Regulatory & Legal Affairs in Russia 2015” Conference

15 Sep 2014

Pharma eReport delivers V5-compliant solution to help MAHs meet December 31st XEVMPD resubmission deadline

20 Aug 2014

ELC Group Appoints Dr. Siddharth Chachad as Head of Global Clinical Development and Medical Affairs

28 Jul 2014

ELC Group Appoints Head of Regulatory Affairs for Russia and CIS

14 Apr 2014

Global regulatory affairs specialist ELC Group appoints Localization Business Development Manager for new US Office

10 Oct 2013

Global regulatory affairs specialist ELC Group accelerates international expansion plans following 25% revenue growth in 2013

17 Sep 2013

Global regulatory affairs specialist ELC Group appoints former MHRA Expert Medical Assessor

23 Apr 2013

Global regulatory affairs specialist ELC Group receives accreditation to provide readability testing in Romania

27 Feb 2013

Global regulatory affairs specialist ELC Group to deliver pharmaceutical training event in Latvia

20 Feb 2013

Global pharmaceutical regulatory affairs specialist ELC Group launches Clinical Trials services

10 Jan 2013

Global pharmaceutical regulatory affairs specialist ELC Group hosts International Training Seminar in Mumbai, India

31 Dec 2012

2012 Events

07 Nov 2012

Global pharmaceutical regulatory affairs specialist ELC Group establishes new office in Singapore

22 Aug 2012

Global pharmaceutical regulatory affairs specialist ELC Group increases operational support in Ahmedabad

12 Jun 2012

XEVMPD software provider Pharma eReport launches Excel Data Import Service

06 Jun 2012

ELC Group partners with mdi Europa GmbH to offer end-to-end regulatory solution for medical device companies in Europe

28 Mar 2012

ELC Group joins DIA EuroMeeting in Copenhagen

21 Mar 2012

EVMPD software provider Pharma eReport announces full general availability of Centrality XEVMPD compliance solution

08 Mar 2012

ELC Group Hosts Successful International Regulatory Seminar

06 Mar 2012

Pharmaceutical regulatory affairs specialist ELC Group opens new office in Mumbai

23 Feb 2012

Regulatory challenges for 2012 and their impact on marketing authorisation

21 Feb 2012

ELC Group launches new software subsidiary Pharma eReport to provide complete EVMPD compliance solution

08 Feb 2012

Pharmaceutical regulatory affairs specialist ELC Group establishes global HQ in Cambridge, UK

07 Dec 2011

Past president of TOPRA and ELC GROUP Advisor speaks at International Regulatory Seminar in Ahmedabad 23 February 2012

27 Sep 2011

ELC GROUP Advisory Board’s Dr. Paolo Biffignandi to write opinion column for industry leading publication

12 Jul 2011

ELC Group aim to foster strategic and economic ties within India and China

25 May 2011

ELC Group announces doubled revenues

11 May 2011

ELC Group appoints former TOPRA President