This international drug manufacturing company turned to ELC Group’s team of translation experts to generate high quality product information documentation that met the exacting requirements of a Scandinavian regulatory agency and would enable the company to achieve marketing approval in a key European national market.
When completing marketing submissions for a new generic product in Finland, this pharmaceutical company encountered a significant commercial challenge. With just five days to go before the expiry of its submission deadline, the company received the news that FIMEA – the regulatory agency for Finland – had rejected all of its patient information and medicine labelling as not fit for purpose.
With the clock ticking, the company urgently needed to generate and submit new text for the summary of product characteristics (SPC), patient information labelling (PIL), and labelling that met FIMEA’s stringent requirements and conformed to European Medicines Agency (EMA) guidelines.
ELC Group solution
ELC Group’s expert submissions team assessed the FIMEA feedback in readiness for generating text appropriate for the Finnish market. With just days to get the documentation submission completed and approved, the pressure was on to ensure the delivery of high quality customer and product information texts that met all local market regulatory requirements.
ELC Group brought together a team of pharmaceutical linguistic experts to ensure the documentation it generated would meet the technical and quality requirements of the Finnish assessors. As a regulatory affairs company ELC Group has over a decade of expertise in the medical, legal and marketing translation expectations of EMA assessors.
Uniquely, the ELC Group has a dedicated linguistic team of medical translators/medical writers who comprehend the precise local requirements of every European market and are skilled at ensuring consistency of forms between all medicine related documents – in other words, utilizing the same terms and phrases already approved by the EMA.
- An initial translation was undertaken first by a specialist pharmatranslator with a deep understanding of the local regulatory agency’s requirements.
- Proofing and editing was completed by a second pharma-trained local translation specialist; a native speaker of the target language, this specialist was able to check all mandatory phrases were included and that documentation scored highly in regard to ‘readability’ for all local audiences (health professionals, pharmacists, and patients).
- All texts were then reviewed by a third group to ensure different linguistic aspects of the texts (terminology, phraseology, formatting and so forth) were consistent between all documents. The PIL was once again checked for consistency with the SPC, and given a readability assessment to ensure it could be easily understood by non-professionals. QRD template and Blue box requirements were checked, using ELC Group’s Pharma Translation Memory software capability, to rapidly generate required text for all documents.
- A final ‘sanity and proof of concept’ check was completed before submission was completed to FIMEA on time, and approvals were gained. The entire process was completed in under five days.
- ELC Group’s team of translators deal with EMA assessors on a daily basis. Uniquely, they combine linguistic knowledge with specialist medical knowledge and a deep understanding of regulator expectations.
- Currently there are 24 official languages in the European Union, and many other additional languages exist at a regional and national level. These include languages of the Baltic countries (Lithuanian, Estonian and Latvian) and Scandinavia (Denmark, Norway, Sweden and Finland), as well as the Slavic languages (Czech, Polish, Slovak, Bulgarian, Croatian, and Slovenian). Managing 24 target EU languages can be a hugely complex task that is best handled by specialists who understand the unique regulatory and local language variations of target European geographies and markets.
- Utilizing an expert medical translation team to coordinate and manage country-specific and culturally appropriate translations can eliminate significant time and cost when marketing medicines into European markets.
- ELC Group is able to draw on its linguistic capabilities and regulatory knowledge to ensure that accurate submissions can be completed to deadline, ensuring marketing approvals are achieved in a cost-effective and timely manner.
- Unlike machine translation or general translation agencies, ELC Group delivers specialist multilingual medical translation capabilities that ensure consistent and accurate translations which are appropriate for medicinal product information. This information is meticulously checked against regulatory guidelines to minimise costly submission/documentation production errors while ensuring first-time acceptance and approval by national agencies.