As discussed in part one, the pharmaceutical industry faces some tough regulations which must be met in a tight timeframe before they can launch a new product within the EU. Here we explore the documentation process when applying for drug registrations.

Manufacturers cannot apply for  drug registration without submitting the relevant translated and properly localised versions of the required documents (see part one) to the European or national regulatory authorities. To achieve approval it is crucial that the manufacturer and the chosen translation agency focus 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.

The most important and comprehensive document that must adhere to this process is the Summary of Product Characteristics (SmPC), which details the purpose and characteristics of a given drug. The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms and known adverse reactions.

Translation process

Prior to the SmPC being created it is necessary that quality assurance is carried out at source, in what is called the pre-opinion phase. The translation partner 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, a reputable translation provider should work with their clients on source documents to anticipate the requirements of target language markets and to ensure that they take into account stylistic guidelines, content standards (i.e., headers, statements, and terms), and format and layout considerations.

The SmPC is produced for the approval and development of medicines and is the basis of information for healthcare professionals, such as doctors, nurses and pharmacists, and explains how to use and prescribe the medicinal product safely and effectively. SmPCs are written and updated by the Regulatory Affairs Departments of pharmaceutical companies and are based on their research and product knowledge.

The SmPC is checked and approved by the local or European Union medicine licensing authorities. This document is then used as the basis for the Patient Information Leaflet (PIL). It is inserted into the drug pack, and includes information about how to use the medicine safely and correctly. The PIL has essentially the same information as the SmPC, but must be written in such a way that it can be easily understood by non-professionals.

SmPCs and PILs issued by pharmaceutical companies have to meet the requirements of the drug regulatory authorities in the country/countries where the drug will be sold. For European Community countries, on top of the requirements of the country’s own drug regulatory authority, this also means meeting the requirements of the European Medicines Agency (EMA).

It is also common for there to be updates to products in the course of the first year of release, due to new developments or legislation. Should this be the case then the pharmaceutical company must adhere to the same process as when applying for initial approval. This will result in the need for further translation requirements.

It also goes without saying that in this industry, incompetent translations and mistranslations can lead to disastrous consequences. To eliminate any possible risk, Regulatory Affairs Departments of pharmaceutical companies need to work together with professional language translation providers, preferably on a long-term basis.

In part 3 we explore the different components that come together to result in a successful registration and look to the future of the pharma industry.