Here's to a Year of Compromise - Pharmaceutical Technology

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Here's to a Year of Compromise
The benefits of harmonization may be on industry's wish list, but buying into change is another story.


Pharmaceutical Technology
Volume 36, Issue 1, pp. 12


Angie Drakulich
It is in the New Year that we often set goals to improve ourselves, whether it's trying to get fit, move up the career ladder, spend more time helping others in need, or any other number of personal quests. But individuals aren't the only ones who make long-term goals—so do governments, organizations, and for our purposes, this industry. Harmonization of drug development and manufacturing approaches comes to mind.

I'm a big supporter and follower of harmonization initiatives, but I get the feeling that not everyone in industry is as gung-ho about the idea. At several industry meetings during the past year, I've asked people what they think of harmonization and whether they believe certain aspects of pharma manufacturing will ever be harmonized (e.g., elemental impurity limits).

I've asked conference participants, for example, about why it's necessary for each nation or region to have its own pharmacopeial guide and for an international pharmacopeial guide to exist. And, for drug-applicants working to bring a product to the global market, is there a way to avoid filling out the same information on 20 different forms? Inspections are another area lacking harmonization. We all know how many audit or inspection teams companies must accommodate in a given year.

Most of the answers I've gotten are along the lines of, " I don't know," or "They would never agree to compromise on that," or, "There's too much national pride for one country to change its standards to match another's."

I get that compromise is difficult. In fact, before coming to Pharmaceutical Technology, I spent several years working for a nonprofit focused on the work of the United Nations. So I understand how much effort is required to engage productive dialogue and garner compromise among a diverse and global audience. I also get that the bio/pharmaceutical industry is highly protective of its information and practices—it is a competitive, patent-based, trillion-dollar industry after all. But I also think that some of the key elements of harmonization are getting lost in translation.

Industry seems to want globally standardized approaches to their processes and quality systems as well as minimal routes for filing marketing applications and other required documents. Reaching these goals would make life easier for all parties involved. Having an agreed-upon, worldwide approach to quality and supply-management, for example, could literally solve many of the drug-product contamination and adulteration issues that have plagued the industry in recent years. And yet, many companies and national regulatory or standard-setting bodies seem unwilling to give up their current practices or accept that another company, organization, or nation for that matter, may have a better way of doing things.

Perhaps my vision of global harmonization is too lofty or na´ve. But there is reason to hope. The International Conference on Harmonization was established in 1990 with the aim of increasing "international harmonization of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner." In its 20-plus years, ICH has managed to gain consensus across North America, the European Union, and Japan, on 16 Efficacy guidelines, 10 Quality guidelines, nine Safety guidelines, and has several multidisciplinary guidelines in the pipeline. The members of ICH's Global Cooperation Group extend the reach of these guidelines to eight additional countries, including the leading markets in Asia.

Other global standard-setting bodies, such as the International Pharmaceutical Excipients Council and the International Society for Pharmaceutical Engineering, are working to shape global industry practice. And new industry groups working to share best practices throughout the world seem to be popping up every month (e.g., the Rx–360 and IQ consortiums).

I hope you will take time to learn more about global harmonization efforts and talk with your colleagues about how your organization might become involved, whether that means providing feedback, working to implement harmonized guidelines, or sharing them with your global partners. In the meantime, Pharmaceutical Technology will do its best to keep you apprised of happenings tied to harmonization and what it means for your day-to-day operations—and that's just one of many resolutions we intend to keep this year.

Angie Drakulich is editorial director of Pharmaceutical Technology. Send your thoughts and story ideas to
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