Regulatory information – Revision of procedural guidance to reflect update of variations guidelines from the European Commission


25/07/2013 – Regulatory information – Revision of procedural guidance to reflect update of variations guidelines from the European Commission

The European Medicines Agency has revised its procedural guidance for pharmaceutical companies to reflect the recent changes to the European Commission’s guidelines on variations to the terms of marketing authorisations for medicines for human and veterinary use. Changes are applicable as of 4 August 2013.

This revision of the variations guidelines has been principally triggered by the implementation of the pharmacovigilance legislation. It also takes into account the experience gained since the release of the current guidelines.

The main changes of the revision include the creation of two new classification categories of variations:

In addition, the Agency has updated a number of existing guidance documents to reflect the new requirements.C.1.11 related to obligations and conditions of a marketing authorisation, including risk management plans;
C.1.13 related to submission of studies to a competent authority; as a result some of the data previously submitted as a post-authorisation measure will now need to be filled as variations applications.
To assist pharmaceutical companies in the implementation of these new requirements, the Agency has developed an overarching Q&A document providing an overview of the most important changes which apply to applications for a variation and submission of post-authorisation measure data for human medicines.

The Agency will publish another set of regulatory updates by 4 August 2013. It will include:

a revised guidance document related to work-sharing procedures for variations to marketing authorisations;
an amended template table to be used for any variations submission to the Agency;
a tabular overview with more detailed information on the updated documents.
Pharmaceutical companies are advised to check the What’s New page on the Agency’s website to find these updates.

The variations guidelines affect applications for human and veterinary medicines. Guidance documents related to veterinary medicines will be updated shortly.

Source: EMA press releases –

EMA publishes guidance on preparing and reviewing summaries of product characteristics

logo_ema21/01/2013 – The European Medicines Agency has published guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. The guidance consists of a set of presentations detailing the information that should be included in each of the sections of the SmPC, together with background information on SmPCs both as a presentation and a video. Two videos explaining how to complete the SmPC sections on the therapeutic indication and pharmacodynamic properties of a medicine and on undesirable effects are also available.

The guidance, prepared by the Agency’s SmPC Advisory Group, outlines the principles in the European Commission’s guideline on SmPC. It is intended to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the Agency as part of applications for new marketing authorisations or updates to existing marketing authorisations.

The background presentation and video also aim to raise awareness of the information provided in SmPCs among healthcare professionals.

SmPCs are a key part of the marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge.

SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients.

Source: EMA News

Proactive publication of clinical trial data – discussing the way forward

09/08/2012 – The European Medicines Agency has announced that it will proactively publish clinical trial data and enable access to full data sets by interested parties. A number of practical and policy issues need to be addressed before complex data sets can be made available.

The Agency is organising a workshop on 22 November 2012 to listen to the views, interests, and concerns from a broad range of institutions, groups and individuals. Results from the workshop will help the Agency define the modalities of proactive access to clinical trial data, in a way that best serves patients and public health in an open and transparent forum.

Registration is open until 31 October 2012. Expressions of interest should be sent to by 31 October 2012. Places are limited to 150 and will be offered on a first-come-first-served basis.

Source: EMA News and press releases –

International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries

Research and Markets has announced the addition of John Wiley and Sons Ltd’s new report International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries to their offering.

After taking part in an EU Leonardo da Vinci project to create a complete curriculum for a Master’s degree in IT Validation, Siri H. Segalstad decided to write this book as she realised there was a need for a comprehensive book that rings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.

This text allows the readers to acquire not only knowledge but also understanding of quality thinking and to apply this knowledge. It will allow them to use the Quality Management System (QMS) as a tool for further development in their organization and to assess QMS from other companies during a supplier audit.

This book will enable the user to understand the process of validation, how to divide validation into manageable pieces, and what is included in the validation for different types of systems.

Topics covered include:

- Quality standards
– Regulatory requirements for IT systems
– Quality Management Systems-QMS
– Organization for an IT system
– Legal implications of an IT system
– Advanced quality management systems
– Validation process and validation techniques
– Validation of IT systems
– Risk assessment and risk management
– Laboratory Information Management Systems (LIMS) and Building Management Systems (BMS)

This comprehensive text will be useful to those working with quality assurance and validation of IT systems and in regulated industries, regardless of which standards they are using.
For more information visit Research and Markets

Source: John Wiley and Sons Ltd
Business Wire 

New pharmacovigilance legislation comes into operation

Better protection of public health through strengthened EU system for medicines safety

02/07/2012 – The European Medicines Agency (EMA) welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.

“The progress made in healthcare would not have been possible without medicines and the research and development community behind them. But we need smart regulation for the system to be able to continue to deliver safe and effective medicines,” said the Agency’s Executive Director, Guido Rasi.

“The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent. It gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders.”

The new legislation was proposed by the European Commission in 2008 and adopted by the European Parliament and the Member States in December 2010. Highlights of the new legislation include:

  • establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee (PRAC);
  • clarification of the roles and responsibilities of all actors involved in the monitoring of the safety and efficacy of medicines in Europe and strengthened coordination, leading to more robust and rapid EU decision-making;
  • engagement of patients and healthcare professionals in the regulatory process, including direct consumer reporting of suspected adverse drug events;
  • improved collection of key information on medicines, e.g. through risk-proportionate, mandatory post-authorisation safety and efficacy studies;
  • more transparency and better communication, including publication of agendas and minutes of the PRAC and the possibility to hold public hearings.

The Agency is ready for the first meeting of the PRAC on 19 and 20 July 2012. All Member States have nominated their members. The European Commission has appointed six independent scientific experts who will also serve as members. The nomination of PRAC members representing patients and healthcare professionals will follow a new public call for expressions of interest.

Information about the roles and the functioning of the PRAC has been published today and can be found on the Agency’s website, together with more information about the new pharmacovigilance legislation.

1. This press release, together with all related documents, is available on the Agency’s website.
2. More information on the new pharmacovigilance legislation is available here.
3. The status report ‘Countdown to July 2012: the Establishment and Functioning of the PRAC’ is available on the Agency’s website.
4. The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010.
5. More information on the work of the European Medicines Agency can be found on its website

EMA boosts EU transparency with online publication of suspected side effect reports




Member States and the Agency release data on medicines in compliance with EudraVigilance access policy

31/05/2012 – The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

The information published today relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing-authorisation holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines.

A side effect (also known as an adverse drug reaction) includes side effects arising from use of a medicine within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and those associated with occupational exposure.

All information on the website relates to suspected side effects. Suspected side effects may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful. All users of the website are asked to read and accept a disclaimer explaining how to understand the information before they view a web report.

Medicines are an important part of modern healthcare, providing effective treatments for many diseases and conditions. For a medicine to be authorised for use in the EU the benefits of the medicine must always outweigh the risks.

Today’s launch also highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the EU. Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the Agency continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection.

In June, the Agency will launch the website in the remaining 22 official EU languages.

Press release issued May 31st, 2012 on the EMA website –

European Medicines Agency publishes new versions of controlled vocabularies

The European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines

The European Medicines Agency has published a set of updated versions of Extended EudraVigilance product report message (XEVMPD) controlled vocabularies. These vocabularies support marketing authorisation holder compliance with Article 57(2) of the 2010 pharmacovigilance legislation, which requires marketing-authorisation holders to submit information to the Agency electronically on all medicines for human use authorised in the European Union by 2 July 2012.

The controlled vocabularies will be updated regularly to improve the standardisation of the terminology used in the electronic submission of medicinal product information to the Agency.

A marketing-authorisation holder that has already submitted medicine information to the Agency using the previous version of the controlled vocabularies is not required to resubmit this information. Marketing-authorisation holders are required to use the latest versions of the controlled vocabularies for submissions of medicine information as soon as they are published on the Agency’s website.

The updated controlled vocabularies are available on the EMA website

And the winner is….

It seems The Stinging Nettle totally honored its name. I was amazed at the number of aggressive, sometimes even insulting comments and e-mails we’ve been receiving since the beginning of this action – it’s just fascinating how many people felt personally attacked. Anyway – here’s the promised result ;)

Whoever works in the medical translation field should be aware of the numerous existing standards (DIN/EN/ISO…) in this industry. Often, these standards even state the exact wording of entire segments. We’ve been so far expecting from translators to be able to identify whether a piece of text is subject to a certain standard (or could be) and accordingly conduct a search or contact us and simply ask. In this specific case, the relevant standards to use were DIN EN 980:2008-08 “Symbols for use in the labeling of medical devices; German version” and the draft standard DIN 6877-1:2007-12 “Magnetic resonance equipment for human use – Part 1: Instructions for labeling items within the controlled area”.

“Keller”, though not specialized in medical device texts, submitted a translation that was the closest in line with the rules of these standards and therefore earns the 50€. “S.W” (who’s no medical translator either) and “AL” did realize that those were texts that were probably set in standards but unfortunately did not submit any proposal.  I found “Michael’s” proposal very interesting as well – he is not a translator but his translation was qualitatively not different from many proposals.

You can read all proposals here and here

What did we learn?

None of the translators who participated knew the standards. Some found them as they were researching and translated correctly but most would probably have made a “wrong” translation of the segments. It occurred to us that during our time as freelancers, no agency ever said to us that a given part of the text was subject to a given standard nor ever provided us with these standard existing translations available (though this does not completely apply for pharmaceutical texts as some agencies take the time and provide their translators with all standards). We came therefore to the decision that, in the future, we will be informing our translators when we give them a new project where standards apply and make those standards available to them.

I would like to thank all translators who participated. It was an interesting experience and we did learn something. We hope that translators in the future will also pay more attention to regulatory requirements in the medical technology field, and keep themselves up-to-date with these as well.
The next “translation survey” is already in the oven and we’d be delighted if you decide to participate again, or participate for the first time!

Watch out! A new trend in pharma marketing – GIGO – SEO

In the past few months, we were involved in localizing various websites targeting certain patient populations. These projects were all sponsored/run by big pharma and these websites all claim to provide useful information, e.g. for people interested in participating in clinical studies or supporting patient education on health problems.

After a while it became obvious that most of these websites contain highly SEO optimized content serving only one purpose:  driving traffic to the pharma companies’ websites or their dedicated websites for given products/clinical studies.

Since these sites are extremely SEO optimized, which results in high rankings in the various search tools, they divert traffic from more impartial websites run e.g. by patient organizations.

Some might consider this a highly questionable trend in itself, but this is not my point.

The problem for me lies in the fact that huge parts of these web pages’ content seem to be created by marketing copy writers – it seems they’re given a list of SEO keywords, and they just have to produce page after page after page using these keywords.

Wrong and even dangerous contents

In contrast with what you would expect from a responsible pharma company, nobody seems to check this content, which results in statements such as:

-    The objective in diabetes treatment is to achieve the lowest possible blood glucose level.
This is not only wrong, but also extremely dangerous, as this would cause hypoglycemic coma.

-    The red blood cells transport oxygen to the lungs
This is plain wrong. The red blood cells transport oxygen from the lungs to the tissue.

-    Hemoglobin transports the carbon dioxide to the lungs
I consider this statement as being incorrect too, since only 5-10 percent of the carbon dioxide is transported by hemoglobin.

These examples have been edited so that you can’t identify the respective websites, but their aim is to help you understand my point that these websites don’t even get the most basic medical facts right. Looking at more complex content, e. g. relating to cancer treatment, the situation isn’t any better.

Localization requires more than just translating contents

Another aspect of these websites solely created for SEO purposes, is that they really don’t care about the reader. Quite often you will find that:
–    the only contact option they offer is a toll free phone number in the US (on the localized pages) which you can’t even contact from abroad,
–    they only provide links to English sources such as patient organizations
–    there are no literature references in the target languages.

What this means to the translation industry

As a language service provider, our role is to raise these issues with clients. We should not contribute to multiplying wrong or even dangerous content by translating it. We should also stress the fact that localization requires more than just translating the content.
By doing this we will not only help our clients by preventing costly legal actions if somebody gets harmed after following wrong instructions and by raising the quality of the content and giving the websites a more professional image. Badly localized websites also damage the reputation of our own industry, as many readers might believe it was the translator who introduced these errors.

The European Medicines Agency (EMA) has published new QRD templates again

On October 121th, 2011, the EMA updated its QRD (Quality Review of Documents). Those are very important tools for all language service providers (LSP) working in regulatory affairs.

The latest version of the multilingual templates can be downloaded here.