As an international pharmaceutical translation provider, Moravia guides drug companies through the regulatory requirements that define the opportunities for pharmaceutical sales across the European Union and in each of its member states. Our interest is in helping you — Marketing Authorization Holders or MAHs for new drug products — translate your pharmaceutical product (and win business) in the more than 20 official languages of the European Union.
The European Medicines Agency (EMA) and its Committee for Human Medicinal Products (CHMP) form the body charged with the scientific evaluation of applications for European marketing authorization for human medicines. Its Working Group on Quality Review of Documents (QRD) is specifically responsible for linguistic quality -- each Member State has two experts on the QRD who ensure that product presentations meet the centralized, regulatory standards of the EU and the EEA-EFTA states (Iceland, Liechtenstein, and Norway).
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Alongside agency scientists, QRD members create the standard templates, terminology lists, and guidelines that govern the translation of product information and labeling. Their mandate covers 23 official languages (including Icelandic and Norwegian) in text or, where applicable, in Braille for blind or partially impaired persons.
In the regulation of a multilingual pharmaceutical presentation, the Agency’s primary mission is clear: namely, to provide patients and healthcare workers with accurate, clear, legible, and understandable language on a drug product to ensure its appropriate and safe usage.
If the package leaflet is well designed and clearly worded, this maximises the number of people who can use the information, including older children and adolescents, those with poor literacy skills and those with some degree of sight loss.
To achieve this, the Agency focuses on three components: the summary of medicinal product characteristics (SmPCs; located on the outer packaging), labelling (located on the inner containers such as blister packs, bottles, and vials), and the package leaflet.
In what is called the pre-opinion phase, the Agency will first conduct a detailed review of the English language versions of the drug sponsor’s SmPC, labelling, and package leaflet. Because translation quality is determined before translation ever begins, Moravia works with clients on source documents to anticipate the requirements of target language markets and to ensure that they take into account Agency stylistic guidelines, content standards (i.e., headers, statements, and terms), and format and layout considerations.
While technical formatting issues may come as a surprise to those of you who are new MAHs, remember that the Agency is highly concerned with consumer understanding of pharmaceutical products. Font sizes, colors, pictograms, and text positioning all contribute to readability and overall comprehension, regardless of the language.
Agency representatives will respond within 110 days with a review of the Technical PIQ (product information quality) as an annex to the scientific comments. Applicants are expected to correct the English source documents in accordance with the PIQ or answer to which comments were not taken into account and why. The improved English product information is then forwarded to QRD members as well as representatives of patients’ and consumers’ groups for written comment. While a meeting with members and representatives is possible (Day 165), this is only if deemed necessary by the applying party.
The Agency issues its decision (the opinion) on Day 210 after ensuring that the English source documents accurately meet regulatory requirements and are of suitable quality -- no more, no less.
Like in other markets, the pharmaceuticals industry is moving at an accelerated pace, an outcome driven by threats from biotechnology, generics producers, and the loss of brand protections at the “patent cliff.” Getting new drugs to market quickly requires, of course, gaining regulatory approval quickly.
The key advantages of the Agency’s centralized procedure are process efficiencies, terminology consistencies, and reduced costs -- measures that benefit both consumer safety and industry bottom lines. Nevertheless, the speed at which this centralized process operates presents a challenge for companies entering the multinational marketplace. The period between the issuance of the Agency’s opinion and the due date for the submission of the approved product information in all other EU languages (including Icelandic and Norwegian), for example, is a mere 5 days.
An experienced pharmaceutical translations vendor brings unparalleled value in this process. Beyond well-established industry standards for translation quality, these vendors bring knowledge and expertise in the life sciences sector. These include:
Project managers play an especially vital role in this post-opinion phase -- namely by working with clients within the pre-opinion phase (prior to Day 165) 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 PIQ (Days 210-214), and delivery of those product information translations and the required QRD forms (Day 215).
All players, tools, and processes are expected to perform efficiently, but with quality targets unmatched by translation jobs in many other industries. Accuracy, readability, and quality assurance are in focus in the next phase of the process: Days 215 to 229, during which the Member State Review takes place.
Those in-country experts deliver their opinions on the translations to the QRD, the Agency then issues overall feedback and the expected corrections on Day 229, and drug sponsors -- working with their translation providers -- deliver final translations by Day 235.
Until recently, all source documents, revisions, translations, and final documents in all 22 languages were to be submitted in Microsoft-Office-2003-compatible formats and PDFs. However -- in a bid to improve data quality, embrace paper-reduction strategies, and re-use common terms and statement strings -- the Agency has declared that, as of July 2, 2012, all MAHs must submit all information on medicinal products for human use electronically.
Moravia has long held that the promotion of standardized 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 Agency’s decision builds upon already successful implementation of structured data tools in other industries, namely IT and communications.
Helping drug sponsors understand, respond to, and implement these changes within their own terminology and content management systems will be critical to creating an increasingly responsive (and successful) pharmaceutical industry in the EU market.