The Sixth International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH6) was held in Osaka, Japan, on November 12-15, 2003. The theme of the conference was New Horizons and Future Challenges. This report provides a program overview and discusses selected sessions and presentations that are more relevant to pharmacoepidemiology and pharmacovigilance.

The conference began with three satellite sessions, followed by the opening plenary session, common technical document (CTD) breakout sessions, topic breakout sessions, and the closing plenary session.

Satellite Session I — Partnerships in Harmonization — organized by the ICH Global Cooperation Group, provided a forum for discussing the collaborative efforts on the harmonization initiatives in the non-ICH regions, such as Southern African Development Community (SADC), Pan American Network of Drug Regulatory Harmonization (PANDRH), Association of Southeast Asian Nations (ASEAN), and Asia-Pacific Economic Cooperation (APEC). The presentations focused on the ICH guidelines regarding Ethnic Factors, Good Clinical Practice, Stability, and CTD. Satellite Session II — MedDRA (Medical Dictionary for Regulatory Activities) User's Group — highlighted current activities at the MedDRA Maintenance and Support Services Organization and the MedDRA Japanese Maintenance Organization, as well as updates regarding regulatory requirements from the US Food and Drug Administration (FDA), European Medicines Evaluation Agency (EMEA), and the Ministry of Health, Labor, and Welfare (MHLW) of Japan.

In Satellite Session III — Gene Therapy — current issues, such as adenoviral and other reference materials, inadvertent germline integration, and insertional mutagenesis/oncogenesis was discussed.

In the opening plenary session New Horizon for the Pharmaceutical Sector, two presentations were particularly relevant to pharmacoepidemiology. Mr. Osamu Nagayama, Chugai Pharmaceutical, pointed to bioethics, regulatory standards for new technologies, public understanding and acceptance, and global availability of high-tech medicines as key issues in the new era of drug discovery. Dr. Murray Lumpkin, FDA, emphasized public health relevancy and integrity of drug regulatory systems, referring specifically to the issues of product access in unregulated environments, counterfeits, and bioequivalence of generic drugs.

The three ICH guidelines relevant to pharmacovigilance, which had been newly released or under development, were the focus of the breakout session titled Pharmacovigilance and Regulatory Communication. Min Chen, FDA, discussed the addendum to Guideline E2C (Periodic Safety Update Reports, or PSURs). Chen identified two challenges: synchronization of national and international birth dates, and reconciliation of PSURs with license renewal requirements in the EU and Japan. Chen also mentioned the importance of indication-specific patient exposure estimates in addressing safety concerns of off-label use. Dr. Teiki Iwaoka, Sankyo, spoke about Guideline E2D (Post-approval Safety Data Management); the essence of the guideline would be a) definitions and terminology, b) sources of case-level safety reports, c) standards for expedited reporting, and d) Good Case Management Practice. Dr. Yusuke Tanigawara, Keio University, discussed Guideline E2E (Pharmacovigilance Planning), which aims at harmonization and consistency of post-marketing pharmacovigilance activities. A pharmacovigilance plan prepared according to the guideline could be submitted at the time of new license application; communication with regulators before approval would be essential.

In the session on Guideline E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data), Dr. Robert O'Neill, FDA, stated that the guideline had not intended to require bridging studies every time; he referred the audience to the Questions and Answers document for clarification. Dr. Masuhiro Kato, AstraZeneca, Japan, discussed the industry view of the guideline, quoting differences in medical practice across countries and in biological drug response among ethnic groups as perceived barriers to the acceptance of foreign clinical data.

In the closing plenary session, eight speakers representing industry and regulatory agencies presented their view of future challenges in the face of new approaches for the development and assessment of innovative therapies. Multiple speakers expected an increasing role of pharmacogenetics/pharmacogenomics. Dr. Lara Hashimoto, Hofmann-La Roche, expressed concern regarding the submission of genomic data to regulators in the absence of coordination among the FDA, EMEA, and MHLW. Dr. Hashimoto also pointed out the complexity of developing a therapeutic and related diagnostic in parallel. On the non-genetic front, Dr. Lumpkin of FDA shared his view that risk management should be more than managing adverse events.

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