Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, the ICH has benefited regulatory authorities.
Pharmaceutical Technology talks to FDA’s Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, the ICH has benefited regulatory authorities.
In late October, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri (USA). As already reported by Pharmaceutical Technology, a major success of the meeting was the adoption of several annexes to the Q4B guideline on pharmacopeial texts.
ICH, which will celebrate its 20th anniversary in 2010, has come quite a long way since it was founded. Established in 1990 as a venue for pharmaceutical regulators and industry experts around the world to discuss how to harmonize the safety, quality and efficacy of medicinal products, the conference has adopted and begun to implement more than 60 guidelines and guideline annexes. The key to ICH's success is implementation, says Justina A. Molzon. "ICH owes its success as a harmonization initiative to a very dedicated Secretariat and the efforts of its expert working groups to generate science-based consensus guidelines," she says.
Molzon, a captain in the US public health service commissioned corps, is the associate director for international programmes at the FDA's Center for Drug Evaluation and Research. She represents the FDA in the ICH's Global Cooperation Group (GCG) and in the independent Regulators’ Forum.
Molzon compared ICH with two other global harmonization bodies, the World Health Organization and the Pan American Network on Drug Regulatory Harmonization (PANDRH), as part of a recently published book by Springer, Pharmaceutical Stability Testing to Support Global Markets. Although ICH represents what Molzon calls the "corporate" version of the three bodies, its advantage is that it now has "a common regulatory language in the common technical document (CTD) and input that other countries can use." The conference can truly focus on implementation rather than talking around the table, she adds.
In addition, ICH guidelines carry a lot of weight because regulatory bodies in the US, EU and Japan place approved (Step 5) guidelines in their own regulatory publications such as the Federal Register. In fact, in the EU and Japan, ICH guidelines are mandatory. With the FDA and the US specifically, it's beneficial to industry that Step-5 ICH documents are published as guidelines rather than as regulations. "This allows industry to provide feedback and suggestions and to incorporate changes should better science be found," explains Molzon. "If we were to [incorporate these documents] in the regulations, we couldn’t change them. We are at a point where ICH can focus on discussing implementation and dissemination of well-established scientific guidances with interested countries that were not originally involved in the ICH process thereby sharing perceived benefits with regulatory colleagues."
Beyond the six-party system, the founding parties and steering-committee members of ICH include: the EU, the European Federation of Pharmaceutical Industries and Associations, Japan’s Ministry of Health, Labour and welfare; the Japan Pharmaceutical Manfuacturers Association, the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA). But with the pharmaceutical industry expanding across the entire globe, the conference established in 1999 a Global Cooperation Group (GCG) as a subcommittee to share ICH information and guidelines with countries and groups that are not official parties to the ICH organization.
GCG members are able to attend ICH meetings at the steering-committee and working-group level. Members include the Asia-Pacific Economic Cooperation, the Association of Southeast Asian Nations, the Gulf Cooperation Countries, PANDRH and the Southern African Development Community.
The GCG is essentially a "clearinghouse for training," says Molzon. For example, the group recently put together a training program in Beijing on good manufacturing practices and quality implementation (ICH Q8, Q9, and Q10). “We make sure that things are done multilaterally so that everyone has a role to play,” she adds.
Despite the existence of the GCG, ICH regulators decided more was needed to take harmonization to the next level. So in June 2008, a Regulators Forum was established. Although the forum is not technically part of ICH, its meetings are held in conjunction with ICH meetings and the same groups that participate in the GCG also participate in the Regulators Forum. In addition, individual countries are represented in the forum, including Australia, Brazil, China, Chinese Tapei, India, Korea, Russia, and Singapore.
"Regulators only can talk about how they are implementing things, discussing what they do, how they trained their staff, and so forth," says Molzon about the forum. Currently, forum participants are focusing on how they conduct reviews within their own regulatory bodies. Ever since ICH adopted the CTD and now the electronic CTD for filings in 2000, it makes sense that regulators review the information in a similar way as well, explains Molzon.
Looking ahead, both the GCG and Regulators Forum would like to bring in additional countries to extend the reach of harmonization. If a country is interested in implementing ICH guidelines and requests to be involved, they can be, says Molzon.