Proposals for consideration "Proposals for careful consideration" by the EC, EMEA, and FDA are, firstly, increased bilateral collaboration on EU- and
U.S.-located inspections, formalization of the exchange of information, and coordination of inspections in third-party countries.
Secondly, they include the use of one bioequivalence study to support a generic registration in the EU and United States.
Finally, tasks such as individual risk management plans, scientific guidelines, and information on pediatric development plans.
Industry fully supports the concept of a mutually recognized inspection report, which would not only honor the fact that Good
Laboratory Practice (GLP), GCP, and GMP guidelines apply in all ICH regions but would also facilitate site changes by the
sponsor, which currently occurs in practice. Having one competent authority from a single region inspecting a manufacturing
or research site would not only reduce resources and time spent by the authorities, it would also save costs incurred by the
sponsor, which is of particular interest for smaller-size companies. Mutual acceptance of bioequivalence studies for generics would help in bringing generic products onto the market faster and
thus improve medical care, especially from a pharmacoeconomic point of view, which is a major focus of today's national health
care systems. Visionary proposals A number of further proposals that might require legislative changes are also under consideration, including minimizing the
EU retesting of medicinal products on importation from outside of the EU, harmonization of time frames for assessment of clinical
trial authorizations (thus having one decision serve both sides of the Atlantic), harmonization of the timelines for submission
of pediatric investigational plans (PIPs), creating one global pharmacopoeia, agreement on pharmacovigilance rules for well-established
products, and harmonization of regulatory terminology. Such topics are unlikely to be resolved during the current harmonization efforts due to the likely need for legislative changes.
For example, although certainly desirable, the creation of one global pharmacopoeia will be a major undertaking and work has
been in progress since the early 1990s. The Pharmacopoeial Discussion Group (PDG) within the European Directorate of the Quality
of Medicines meets twice yearly at various locations around Europe, Japan, and the United States. At each meeting, the PDG
organizes a hearing for representatives of the excipient and pharmaceutical industry (e.g., national associations of manufacturers
of pharmaceutical products), to promote synergy and exchanges of compendial contents and standards. 
Initially Targeted Plans
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The goal is for consensus to be reached by consulting relevant user groups through public surveys and, if necessary, by organizing
conferences with all pharmacopoeial groups and any parties concerned. Harmonized compendial standards are critical if the
goal of registration, market surveillance, and free movement and trade of medicines is to be achieved among as many countries
as possible.
Officially the next steps will be careful public health and legal and practical consideration of the proposals by the EU and
U.S. regulators with a view to release, in the context of the bilateral collaboration, joint prioritized roadmaps for administrative
simplification. In a joint press release dated June 17, 2008, the EMEA, EC, and FDA published a Transatlantic Administrative
Simplification Action Plan, which details the 18 specific projects that will be initially targeted (see Table 2). These transatlantic activities provide both opportunities and challenges for industry. There are real opportunities for industry
to reduce the barriers to transatlantic product development, but there is also a challenge to ensure the simplification solutions
do not become tomorrow's barriers. Furthermore, industry must ensure that its current clinical development plans consider
these regulatory advances. Stuart Mudge, PhD, is general manager & project director, Voisin Consulting Australia Pty Ltd. Christiane Fertig,* PhD, is Project Leader, Voisin Consulting, 3, rue des Longs Prés, 92100 Boulogne-Billancourt, France, email: fertig@voisinconsulting.com
*To whom all correspondence should be addressed.
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