The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, steering committee and expert working groups met in Yokohama in June (6th to 11th) and a number of highlights are outlined  below. What the ICH agree will shape the regulations to come.

Non-Clinical Safety

A significant milestone was achieved in Yokohama with the finalization of the revision of the M3 Guideline “Non-clinical Safety Studies for the Conduct of Human Clinical Trials and for Marketing Authorizations”. The new M3 Guideline promotes more rapid discovery and development of innovative medicines, by reducing the reliance on animals required in drug development studies. These efforts continue ICH’s commitment to the 3Rs (Reduction, Refinement and Replacement) of animal testing.

Clinical Safety and Efficacy

The ICH Guideline E16 “Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions” reached Step 2. The 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. Public comments on the ICH Guideline E2F “Developmental Safety Update Reports” have been taken into account and made good progress toward Step 4. The guideline will harmonize the requirements for annual clinical trial reporting to the regulators in the three regions and will provide an additional level of protection for patients in clinical trials.

Quality of Pharmaceuticals

Progress was made on the harmonization of pharmacopoeia texts in the three regions, which will reduce testing requirements for the industry. Two annexes to the Q4B Guideline (Annex 5 on “Disintegration Test” and Annex 8 on “Sterility Test”) reached Step 4 and another two (Annex 9 on “Tablet Friability” and Annex 10 on “PAGE”) reached Step 2. The Quality Implementation Working Group delivered a set of Q&As to answer questions arising from the Q8, Q9, and Q10 Guidelines. Also of note, was a meeting of the Q11 Expert Working Group “Development and Manufacture of Drug Substances,” covering both chemical and biological substances with wider participation from some non-ICH countries. Work on the topic continued to progress.

The next ICH meeting will be held in St. Louis, MO, USA from October 24-29, 2009.

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If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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