In-country review is a vital piece of the translation quality control for any product or service marketed internationally, including medicinal products and medical devices. However, it can be a challenge for multiple reasons. In this article, I share four steps you should take to get the most out of it.
What is an in-country review?
Depending on the setting, the in-country review can be referred to as linguistic review, affiliate review, or client review. It is a step in the translation process where the translated text is reviewed by field experts or client representatives.
Within the scope of marketing authorizations of medicinal products issued by the European Medicines Agency (EMA), the linguistic review is a mandatory step. Here, affiliates – experts from the local regulatory agency - review the translated text to ensure that it is technically accurate.
This review of the translated product information (Summary of Product Characteristics [SmPC] and Product Information Leaflet [PIL]) takes place after the adoption of the Opinion issued by the Committee for Medicinal Products for Human Use (CHMP). This procedure aims at ensuring high quality and consistency of Centrally Authorized Products (CAPs) in all Member States.
In the context of medical devices, the goal of the in-country review is to have accurate translations in terms of product specifications, adequate to the target markets, and in-line with branding features. Instructions for Use (IFUs) are just one of many materials that may be reviewed by a locally based employee, distributor, or subsidiary.
That being said, in-country review can be a double-edged sword.
Often, this is where timelines are compromised, which is unacceptable when you have a tight timeframe – either because of a regulatory requirement or you have a launch date closing in.
In addition, if not done properly, this is where inconsistencies may come up, both within the text itself and with existing products or services, as well as major deviations from the source text.
What can you do to prevent this from happening?
1. Start from the beginning
Establish a plan for project timelines and make sure that every party is aware of the workflow.
Allocate enough time to each stage: translation, in-country-review, and implementation of changes. To ensure that everything goes as expected put a clearly defined schedule in place, ask for availabilities as early on as possible, and encourage everyone to do their best to make it happen.
You want the in-country review step to take place as seamlessly as possible. Therefore, you should choose the right people to work with. First, and I can’t say this enough, work with specialized medical translators. Then, make sure the reviewer has a clear idea of what is expected at this stage.
Reviewers should make use of their strong knowledge of the products or services and focus on the scientific and technical terminology used.
Although they should be proficient in the source language and native speakers of the target language, reviewers should refrain from questioning linguistic aspects and making preferential/stylistic changes – unless there is a major error or deviation that may jeopardize the quality of the resulting text (thus, compromising users’ safety, product approval, outcome interpretation, etc.).
2. Build and share resources
Make as many resources as possible available to both the translator and the reviewer. These include style guides, glossaries, product specifications, reliable reference sources, and templates.
It is useful to have guidelines and checklists describing the responsibilities of each expert and items to check during the review. By doing this, both the translator and the reviewer have a clear idea of what exactly they should pay attention to when working on the text throughout the process.
3. Communicate, collaborate, and track
The translator and reviewer should work closely together by raising and answering questions in a timely manner. More than that, they should acknowledge each one’s expertise in their field.
For example, in-country reviewers may introduce changes that deviate from the source text, introduce non-idiomatic expressions, or make stylistic changes based on individual preference. In turn, translators may mistranslate a technical term, introduce a typo that changes the source meaning, or misinterpret an instruction if they don’t have access to figures or other reference materials.
Hence the need for a collaborative effort and efficient communication between translators and reviewers.
Finally, keep track of all versions of a document and of all edits made to a text. You can do this by tracking changes to a text – “Translator” / “[Target Language]” for the translator and “ICR” / “Affiliate” / “Linguistic Reviewer” for the reviewer are obvious role-based names when anonymity is required.
4. Collect feedback
It is equally important to understand what went well and where there is room for improvement. Once each step is completed, ask for the translator and reviewer to provide their assessment about the workflow and on each other’s work.
This will help you identify potential bottlenecks and optimize processes by maintaining what works and adjusting what does not.
Plus, translators and reviewers will benefit from each other’s comments to ensure that everything goes smoothly in future projects.
Ana Sofia is an English to Portuguese medical translator and writer working with Life Sciences companies, Contract Research Organizations, and Medical Communication agencies. She has experience translating and writing content for clinical trials, medical devices, regulatory submissions, education and marketing campaigns, and scientific publications.