During our recent webinar about translation challenges during EU Marketing Authorization Applications, we were asked the following question about in-country review:
Is there a DWL guideline for affiliates to follow for translation/in-country reviews to minimise […] risks? Is this available for your customers?
The short answer is ‘yes’, but let’s explore this topic a little further.
Affiliate review of translations (or ‘in-country review’), is a common SOP requirement, particularly for pharmaceutical companies with a global presence.
It’s an important step in the translation workflow for many companies but it adds an extra layer to the translation process and should thus be approached with care.
In general, local teams are asked to review translated materials at various points in the translation workflow. This is not in itself a problem.
As timelines are squeezed, however, the extra step in the process can lead to greater pressure or significant bottlenecks at key stages later on.
Is reviewing translations a good use of your colleagues’ time?
It is worth asking how effective in-country review is, as a driver of:
Review of product information in many languages may be performed concurrently by a team of professional translators at a pace of around 1500 words per hour, with progress monitored via a translation management system. Company affiliates, however, have varying workloads and a potentially slower reviewing speed.
To judge the cost-effectiveness of in-country review, check whether changes made to product information by affiliate reviewers are routinely approved by your language service provider (LSP).
Preferential, or purely stylistic, changes applied to product information during the QC stage can result in textual inconsistencies. These can require more translator time to correct and harmonise, at the expense of either the LSP or the customer.
Preferential/stylistic changes can be significant obstacles to consistency, accuracy and adherence to national and QRD guidelines.
Subject matter experts
Local affiliates are subject matter experts but they are not always trained translators.
Involve in-country reviewers directly in the translation workflow combines their product knowledge with the linguistic excellence of a translator.
Affiliate reviewers added to automated workflows on the LSP side are integrated more fully in the translation process. This ensures that reviewers may access files as soon as the previous step in the workflow is completed.
Also, since translations are stored centrally at the LSP’s end, version control is maintained at all times.
The final say
Ultimate approval of translated materials should, in our experience, rest with the LSP. Other stakeholders (including Member State Health Authorities) can’t always be relied upon to provide accurate feedback on many aspects of the translation.
In-country reviewers may be susceptible to certain translation traps, such as:
- Using out-of-date QRD, EDQM or MedDRA terminology or national layout guidelines instead of official QRD layout conventions.
- Making preferential/stylistic changes (including changes made outside of the scope of a procedure).
- Not communicating deadline changes back to stakeholders or the LSP.
- Taking a disproportionate amount of time to review translations or liaise with local health authorities.
- Reviewing languages as a non-native speaker. It’s easy to introduce non-idiomatic expressions and other stylistic errors. Even seemingly straightforward changes may require a high degree of proficiency in order to implement accurately.
To address the issue of quality, affiliate reviewers may be issued with standard guidelines to support their review work. This will help them apply accurate, consistent and compliant changes to regulatory documentation.
Accordingly, a comprehensive guide for in-country reviewers is available to DWL customers.