Work in progress There is still a substantial amount of "work in progress to be intensified." One example is the existing implementation plan
for the U.S.–EU confidentiality arrangements, including the exchange of information on Good Clinical Practice (GCP) and Good
Manufacturing Practice (GMP) inspections, pediatric development plans, and parallel scientific advice (under the existing
pilot program), as well as staff exchanges and training between EU authorities and the FDA. The purpose of the confidentiality arrangements is to allow FDA and EU authorities to share expertise, perspectives, and ideas
for alternative approaches to regulation. The consequences for industry are considerable: The EU competent authorities and
FDA will communicate more often and more intimately. The information exchange covers both regular and ad hoc exchanges, whereby
regular exchanges can include information on preauthorization and postauthorization applications, as well as inspections and
guidance documents, and it applies to all products that fall within the remit of the two agencies. For example, the exchange
of inspection results is proposed to take place on a quarterly basis, comprising a list of inspections (GMP, GCP, and pharmacovigilance)
performed the previous quarter and inspections likely to be performed during the next quarter. Ad hoc exchanges between the agencies, which by definition are not subject to planning, will be classified into three categories:
urgent, expedited, and standard. Examples include provision of scientific advice, encountered difficulties during evaluation
of applications for marketing authorization not covered by regular planned exchanges, product-related pharmacovigilance issues
prior to public release, advance notice of significant regulatory sanctions of mutual interest, and urgent issues of general
public health concern. A central effort of the confidentiality arrangements is the pilot program of parallel scientific advice that will ultimately
be aimed at faster access to new medicines, especially those derived from new technology and intended for advanced therapy
approaches. The goal is a so-called "joint scientific advice" procedure drawing on an infrastructure put in place for the
EMEA, FDA, and pharmaceutical companies to facilitate the exchange of views on scientific issues during the development phase
of new drugs. Two initiatives are foreseen to ensure a smooth implementation: establishment of a coordination committee and a yearly evaluation
of the implementation progress. The committee will consist of a representative from the EC, EMEA, and FDA and their main role
will be handling organizational and operational aspects of the implementation. During the yearly evaluation, experiences gained
will be discussed and proposals for further improvement will be identified. Evaluation is planned to continue into 2009. Over the past few years, there have been several attempts by industry to seek parallel scientific advice from the FDA and
EMEA, and it should be noted that the current procedure requires the sponsor, not the authority, to organize the joint meeting.
Although the EMEA does assign a coordinator, the procedure is not standardized and can be slow, which is especially cumbersome
for smaller sponsors with reduced resources. Also, it should be kept in mind that the FDA considers parallel scientific advice
only for drug products at the pre-IND and end of Phase II stages, rather than at the beginning of clinical development or
for nonpivotal studies. It is advisable to check with the relevant agency beforehand if an advice request relating to an early
stage of drug development is indeed eligible for the procedure. 
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Another example of "work in progress to be intensified" is the harmonization at the ICH level on topics such as clinical trial
annual safety reports and the development of an international standard for pharmacovigilance case reports. Exchange of information
on pharmacovigilance topics (either product or nonproduct related issues) through teleconferences is another objective. Harmonization
efforts so far have included clinical trial annual safety reports per product rather than per trial, which allows a clearer
identification of safety issues and better evaluation of the risk–benefit ratio of a given product. Efforts are currently
being made to reinforce the use of the EudraVigilance database as a common repository for all suspected unexpected serious
adverse events (SUSARs) from clinical trials and postmarketing in order to become an even more efficient tool for identification
and generation of safety signals.
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