This is the 3rd and final part in a series of blogs looking at the pharmaceuticals industry and the stringent regulations around translation of accompanying literature. In part 3 we look at the various components that need to be considered and a look at the future of the pharma industry.
It is essential that translation providers have a dedicated team of project managers when completing a translation for use in the pharmaceutical industry. They play an especially vital role in this post-opinion phase (see part 2), namely by working with clients within the pre-opinion phase on preliminary translations of the English source, version controls that account for differences in dosage forms and product strengths, corrections to all 23 languages based on the “product information quality” (PIQ) and delivery of those product information translations and the required Quality Review of Documents (QRD) forms.
Getting everyone involved
All people, departments and processes are expected to perform efficiently on any translation project, but the difference here is the exceptionally high and mandatory quality targets. These targets are unmatched in any other industry due to the nature of the pharmaceutical sector.
The next stage involves native experts delivering their opinions on the translations to the QRD. The European Medicines Agency (EMA) then issues overall feedback along with the expected corrections. The drug manufacturers in conjunction with their translation partners must then deliver their final translations.
As there are a number of critical steps and some complex procedures, the partner translation provider must also be able to demonstrate a track record in pharmaceutical translations, which provides an unparalleled value to the process. In addition to this, Language Service Providers (LSPs) offer specific value-adds relevant to the life science sector.
These may include:
in-house, native-speaking teams certified in clinical translation for each Member State
a core team of medically qualified linguists
independent medical consultants who provide in-country reviews for linguistic and technical accuracy
back translators who are native English speakers, highly proficient in the target language, and knowledgeable in life sciences
linguists with the ability to use Translation Memory technologies to ensure consistency across all translations
desktop publishing professionals skilled in meeting the requirements of mock-ups and specimens for the QRD.
Until July 2012, all source documents, revisions, translations, and final documents in all 23 languages were to be submitted in Microsoft Office 2003 compatible formats and PDFs. However, in a bid to improve the quality of data, build upon the paper reduction strategies, and ensure that common statements and phrases are re-used, the EMA has introduced a mandatory regulation. This states that all Marketing authorisation holders (MAH) supplying information on medicinal products intended for human use must submit it electronically.
The promotion of standardised guidelines for content authoring, management, and publication is in the best interests of translation providers, pharmaceutical companies, and regulatory agencies worldwide. Besides simplifying submission and review processes for the pharmaceuticals industry, the EMA’s decision builds upon already successful implementation of structured data tools in other industries, namely IT and communications.
It is apparent that there will be an on-going demand for translation in the pharmaceutical industry, and whilst globalisation provides new opportunities, it also presents challenges for translation companies.
Helping drug manufacturers understand, respond to, and implement these changes within their own terminology and content management systems will be critical to creating an increasingly successful pharmaceutical industry in the EU market.
Language barriers should not prevent people from having access to and accurately understanding information about medicines – are you ready for the challenge?
