Please login to the form below

Not currently logged in
Email:
Password:

Digital intelligence blog

Pharma insight on digital marketing, social media, mobile apps, online video, websites and interactive healthcare tools

EMA prepares for digital signature introduction

From next month will accept digital signatures for certain procedures

The European Medicines Agency (EMA) will next month start to accept digitally signed documents for the first time.

In a phased introduction, the regulator will begin with documents related to scientific advice for human medicines, to orphan medicines and to paediatric-medicine procedures.

The initiative is part of the EMA's strategy to increase electronic document-only exchanges between the Agency and the pharmaceutical industry.

The EMA's strategy is to eventually move to an electronic-only workflow, but said the use of digital signatures is “not yet mandatory”.

The EMA's 'eSignature' capabilities allow it to send digitally signed electronic documents (in PDF) and verify digital signatures embedded in such documents.

The changes will allow the EMA to securely archive legally binding digitally signed documents, and it expects to see efficiencies in its filing procedures as a result.

The industry too may benefit, with the EMA noting pharma companies may see cost savings from not having to print documents or courier them to the regulator.

The EMA will provide specific PDF certified electronic application forms to enable pharma companies to digitally sign and submit using a PDF reader application.

The regulator will accept digitally signed electronic documents, and send its own out, through the EudraLink or, where the contents do not require confidentiality protection, by email.

• FAQ: EMA eSignature capabilities

20th August 2013

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Healthcare Media Europe – HME Ltd

HME are an innovative and technology enabled agency offering our clients over 35+ years of knowledge and expertise in delivering...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics