Global Regulatory Leadership from European Medicines Agency

By Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association
as posted on Pharma iQ 09/29/2014

Mollie Shields-Uehling

Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association

I’m an American who has lived in Paris, London, and numerous other countries around the globe. It’s atypical for my generation. The experience has helped me appreciate the best ideas and policies, wherever they originate.

When it comes to greater efficiencies and cost savings in filing electronic submissions, the European Medicines Agency is well ahead of any other regulatory agency on the planet. They’re on record stating…

The Agency expects the exchange of digitally signed electronic documents to increase the efficiency of procedures and eliminate the need to archive paper documents. It may also bring about cost savings for companies, by removing the need to print documentation and reducing courier charges.

EMA uses digital signatures “systematically” in its outgoing documents that require a legally binding signature. Currently these are documents related to scientific advice for human medicines, to orphan medicines and to paediatric medicine procedures. The Agency also provides certified PDF electronic application forms to allow companies to sign these forms digitally using a PDF reader application.

It’s all part of EMA’s “strategy to increase electronic-document-only exchanges between the Agency and the pharmaceutical industry.”

I put digital signatures in bold because it’s an important detail in EMA’s policy that people in industry need to understand. By European Union definition, an electronic signature is “digital” when it is uniquely linked to the signatory; capable of identifying the signatory; created using data that the signatory can use under his/her sole control with a high level of confidence, and linked to the signed document in such a way that subsequent change in the document is detectable.

EMA also requires that the digital signature comes from a Certification Authority (CA) listed on an EU member state trust list.

These requirements provide high assurance of the individual’s identity, allowing the credential to be used for a multitude of purposes including applying legally binding, non-repudiable digital signatures to electronic documents.

Importantly, all EU/EMA requirements for a digital signature are consistent with those used in the SAFE-BioPharma® standard, and credentials obtained through Verizon Business UIS, a credential service provider under the SAFE-BioPharma Trust Framework, can be used to sign EMA submissions.

Why is this important? Drug development is now a global collaborative activity relying heavily on working with people and entities via Internet. This requires technologies that deliver greater trust in cyber-transactions. The SAFE-BioPharma standard was created toward that end.

Several widely available signing engines (e.g. DocuSign and Taigle’s MySignatureBook) have become compliant with the SAFE-BioPharma standard.

And not long ago, Adobe added SAFE-BioPharma to its Adobe Approved Trust List. This means that anyone with a SAFE-BioPharma® identity credential is able to sign a PDF document in Adobe® Acrobat®, or Reader® that will be automatically trusted globally by any other user of Adobe Acrobat, or Reader. The Adobe Approved Trust List (AATL) comprises almost 50 member organizations from around the world, including the US government, Japanese government, and members of the European Union Trust List.

Digital signatures based on the SAFE-BioPharma standard are used to sign electronic laboratory notebooks, regulatory submissions, clinical trial documents, and routine day-to-day business documents. This is what the signature looks like:


Digital identity credentials based on the SAFE-BioPharma standard are used to manage access across firewalls and to portals and to access protected information, such as electronic health records.

By embracing, using, and requiring digital signatures, EMA “…expects to increase the efficiency of procedures and eliminate the need to archive paper documents.” The new policy will advance cost savings for companies by removing the need to print documentation and reducing courier charges.

In the big picture of drug development and submissions, these may seem like minor savings. If you think that, consider the hidden costs of printing, scanning, copying, archiving/locating, shipping paper documents and/or the CDs and other media on which they’re stored.

EMA is improving it’s own operations and coaxing industry to do the same. I hope other regulatory bodies take note.


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