The United Kingdom has always played an important role in the European pharmaceutical industry.

Recent statistics have shown that in 2013 the total UK revenues for this industry were around £15.43bn.

Over the past 18 months though, it appears as though there has been a slight dip in revenue, but according to a recent report by Marketline, there will be a significant drive between now and 2018 which will result in revenues reaching the region of £16.64bn. This climb in revenue will cement the UK’s standing as the fourth largest pharmaceutical industry in Europe behind Germany, France and Italy.  However impressive as this growth is, the UK is some way behind the USA pharmaceutical industry.  They are at the top of the global pharmaceutical tree and the Marketline prediction is for the USA to hit $345bn in 2014.

Translation needs

In recent years there has been a trend towards global consolidation within the pharmaceutical industry. This has meant that more and more acquisitions and mergers amongst various companies are taking place. This shift towards global operations of the industry has been accompanied by a significant increase in the demand for high-quality pharmaceutical translations.

This in turn has led to increasing demand for, and pressure on, specialist medical translation companies that assist in worldwide marketing authorisation approvals in the main the US Food and Drugs administration (FDA),  European Medicines Agency (EMA)  and Pharmaceutical and Medical Devices Agency (PMDA) regulated markets.

Globalisation in the pharmaceutical industry provides new opportunities, as well as significant challenges for translation companies. An international pharmaceutical translation provider must be able to guide drug companies through the regulatory requirements that define the opportunities for pharmaceutical sales across the European Union and in each of its member states.

The EMA and its Committee for Human Medicinal Products (CHMP) form the body charged with the scientific evaluation of applications for European marketing authorisation 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 centralised, regulatory standards of the EU and the EEA-EFTA states (Iceland, Liechtenstein, and Norway).

EU language requirements

Pharmaceutical companies manufacturing within the boundaries of the European Union need to make the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labelling texts available in up to the 23 official languages of the European Union. Furthermore, when more than one language is used, all the above mentioned texts must be available in each individual language and the content of all language versions must be identical.

It is also crucial to point out that EMA sets a strict time frame of 20 business days for translated versions of all documents to be submitted. Within 5 working days after the marketing authorisation is given by the CPMP (the EMA committee responsible for assessing marketing authorisations), initial translations must be provided. By the 20th day, the final revised versions of the translations must be provided to the EMA in their final publishing format.