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European Pharmaceutical Contractor

Multi-Language Labelling

As the pharmaceutical industry becomes more global, managing the complexity of different languages and regulations is a crucial consideration when contemplating the copy and artwork used on product packaging.

Research conducted at the Second Annual Pharma Packaging and Labelling Compliance Conference in Rome earlier in 2012 showed that one of the major packaging issues faced by pharmaceutical companies is ensuring compliance with different regulations in different countries. The research showed that 47 per cent of respondents cited this as an issue. This is compounded by the need to use text in different languages, which 56 per cent of respondents felt was the most critical element in the packaging and labelling process.

Some companies translate labelling and packaging into as many as 23 different languages in Europe but, as the focus turns to Asia and other emerging markets, this inherently complex process reaches another level. The Asian pharmaceutical sector is projected to have a total market value of $69.1 billion (€55.27 billion) by 2016 (1). Of the BRIC emerging markets, Brazil, Russia and India are expected to add between $5 and $15 billion (€4 billion to €12 billion) per country in annual sales to the global pharmaceutical market by 2013 (2). However, no matter how great the scope for growth and opportunities, success is far from assured. Every new market has its own language, governance and regulations, so the complexity of shipping goods internationally is compounded when emerging market countries are involved.

Unique Challenges

When it comes to packaging requirements, companies are presented with a variety of unique challenges such as multi-language labelling. The packaging efforts of pharmaceutical companies looking to tap into these markets will need to be shaped by factors which, while not new, have a far more pronounced importance compared to developed markets.

When managing the globalisation process of packaging and labelling, the approach needs to accommodate many local languages, writing systems and conventions. Companies need to embrace the complexities of the nuances of dialect and locale. With around 6,800 spoken languages and 34 writing systems, equating to approximately 79 written languages, managing the complexity of these is a sizeable challenge. Companies may have been getting by with an Anglo-centric view so far, but as markets become increasingly competitive, they need to focus on the local needs of each customer.

To counteract the risk of getting it wrong, the content, translation and localisation of corporate and product documentation needs to be managed with globalisation in mind. Companies must be active in complying with the growing language and legislation requirements associated with emerging markets, making it easier to attract and keep global customers. Standardisation, the basis for many labelling production efficiencies, is no longer the answer to success.

Optimising Market Opportunities

Failing to manage the myriad of languages within any given market is simply not an option; labelling and translation issues alone can dramatically delay product launches. When you consider that certain countries, such as China and South Korea, have issued their own sets of regulations relating to their languages, the proof-reading process takes on greater importance.

Real Potential for Brand Damage

Defects and errors in pack copy and artwork are two primary reasons for product recalls, and drug label translation errors can pose a very serious threat. The potential effects of revenue and market-share losses, as well as any negative publicity that threatens reputations, can be catastrophic to any brand.

Recent product recalls have seen product safety, quality, and environmental standards in emerging markets rise up the boardroom agenda. Companies are increasingly recognising the need to adhere to more rigorous standards that can cope with the differing requirements of each region. A proactive approach to balance the very different language variants of all the countries within which you distribute is essential, along with robust processes that will help companies ensure safety and quality across far-flung supply markets.

The Needs of a Diversified Client Base

As packaging is a fundamental component of regulatory compliance, inconsistencies in labelling product content is an issue. Aside from the language barriers, global packaging also needs to be tailored to the unique legal requirements of each local market. A maze of very differing legal, compliance and regulatory factors is further complicated by the systematic inefficiencies and frequent regulatory changes inherent within these markets. Companies must anticipate and manage the related risks with great caution in order to reap the benefits that emerging markets provide.

The ability and flexibility to accommodate rapid changes in multi-language packaging and labelling artwork is paramount. If not managed and navigated adequately, growth can be seriously inhibited. When things change, the packaging artwork itself often changes. Reworking a project can incur many additional expenses and plenty of extra work and lost time. Since packaging and artwork changes engage almost every functional discipline inside the company, the profit margins may quickly dissipate. Against this background, artwork management has become a high-stake game, and success is based on a company’s agility in responding to market change.

In order to minimise the risks and be able to respond to this growing complexity, many pharmaceutical companies will have to make some fundamental changes to their operational structures. Uniform processes for the creation, approval and management of labelling content across a pharmaceutical fi rm are sorely lacking. It is no longer enough to manage different languages in document format. The expansion into new markets, speed of change required, and the increasing regulatory burden mean that document management systems no longer have the aptitude to manage the different languages required.

Structured Content is the Way Forward

By breaking down documents into their constituent parts and working at a structured content level, changes can be managed much more quickly, easily and efficiently. A structured content management system drives out duplication and provides companies with the ability to focus on the needs of local markets and regulations, responding to changes faster. By combining structured content with automated artwork generation, companies can make further significant efficiency gains, with robust archive and audit trails making it easier to prove compliance.

For companies prepared to innovate and apply new structured content and artwork management systems that address both language and regulatory requirements, there is light at the end of the tunnel. In the research conducted at the Second Annual Pharma Packaging and Labelling Compliance Conference, 68 per cent of respondents said that an automated artwork management system would provide a quick and easy way to manage change requests for different markets, with 59 per cent saying it would improve quality and efficiency.

The Future

As well as improving efficiency and accuracy in the regulatory process, the issue of multi-language information and effective phrase and translation management provides a very real opportunity to change the way the labelling process is viewed.

The challenge of addressing emerging markets actually offers a compelling opportunity to reduce risk by ensuring greater content consistency across a broad range of products. Only with technology can the ultimate benefits of re-using content and reduced complexity be established. Payback comes from streamlined processes, quicker approval and processing times and a faster route to market. However, the benefits do not have to end there. There is the potential for further efficiencies in the form of automated artwork generation, which further streamlines the packaging and labelling process. In the same research conducted in Rome, 67 per cent of respondents said that they thought automated artwork generation was a reachable goal.

The sooner pharmaceutical companies seize this opportunity, the sooner they will be able to minimise their risks and increase their dexterity in response to market and legislative changes.

  1. 1. Manufacturing Chemist, February 2012 2. Visit:

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Neil Gleghorn has spent his entire career working in the printing design and related software industry, and has first-hand experience of the complex collaborations involved as diverse teams work together to create accurate artwork. 20 years ago Neil founded The Box Room – now one of the UK’s most successful design origination companies and the pre-cursor to Kallik, which he established as a spin-off company in 2001. Using his experience, he devised a highly dynamic solution for use in very competitive and heavily regulated industries over the last 11 years by matching the company’s technology with a diverse range of clients who need it.
Neil Gleghorn
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