Harmonization Steps Move Forward in Tokyo

Last week, the steering committee and expert working groups of the International Conference on Harmonization met in Yokohama, Japan, to discuss pending guidelines and other relevant issues. The theme of the meeting was “Facilitating More Rapid Discovery and Development of Innovative Medicines.”

The revision of ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and for Marketing Authorizations was finalized at the meeting, according to an ICH press release. The new M3 guideline promotes more rapid discovery and development of innovative medicines by reducing the reliance on animals required in drug-development studies, says the release.

ICH E16 Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions moved to Step 2 (consensus of the six ICH party sponsors) of the harmonization process. This guideline “provides recommendations on the context, structure, and format of regulatory submissions for genomic biomarker qualification in order to facilitate submission and review of biomarker qualification data among regions,” according to the ICH release. The next step is regulatory consultation (Step 3). According to the ICH release, E16 will harmonize requirements for annual clinical trial reporting to regulators in the three ICH regions (Europe, Japan, and the United States) and will provide an additional level of protection for patients in clinical trials.

Progress was also made on the harmonization of pharmacopoeial texts in the three ICH regions, which, according to the release, “will reduce testing requirements for the industry.” Two annexes to the Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions reached Step 4 (adoption) of the harmonization process. The two annexes are: Annex 5 on "Disintegration Test" and Annex 8 on "Sterility Test." Annex 9 on "Tablet Friability" and Annex 10 on "PAGE" reached Step 2. The US Food and Drug Administration submitted comments on Annexes 6, 7, and 8, which focus on uniformity, dissolution, and sterility, respectively, in February (see back story).

The Q11 expert working group, which is developing a much anticipated guideline on the development and manufacture of drug substances, met during the conference as well. “Work on the topic continued to progress,” according to the release. Read the business plan for this guideline.

The ICH steering committee and expert working groups will meet next in St. Louis, Missouri, Oct. 24-29, 2009.

ICH also held a public symposium in Tokyo on Friday, June 12, covering recent ICH developments, electronic exchange of information, clinical research safety guidelines, the Q4B guideline on “Evaluation and Recommendation of Pharmacopoeial Texts,” and quality implementation, with a special focus on implementing ICH guidelines in Asian countries. (Pharmaceutical Technology will publish more details about the symposium as soon as they are available.)

In related news, FDA published in the Federal Register last week the revised ICH Q8(R1) Pharmaceutical Development guideline. The revision includes an annex that goes into more detail about quality by design and specifically, design space. ICH representatives adopted the revised guideline in November 2008. Once a guideline reaches final approval and is adopted, is up to the individual regional sponsors such as FDA to distribute the information.