ICH S9, which is designed to expedite the development of treatments for patients with advanced cancers while maintaining safety regulations, reached step 4 of the harmonization process, meaning that there is scientific consensus.
The International Conference on Harmonization (ICH) also discussed guideline ICH S6, which covers “Revision of preclinical safety evaluation of biotechnology-derived pharmaceuticals.”
The guideline, which outlines a reduced duration and number of studies involving animals and could have a major impact on the use of animals in safety testing of biotech drug products, progress to stage 2 of the harmonisation process.
The ICH also reiterated that it is still committed to the “3Rs” approach of reducing, refining and replacing, the use of animals in pharmaceutical research and development.
The ICH also reported that: “There was major progress in the harmonization of pharmacopoeial texts in the three regions which will reduce testing requirements in the three regions [Europe, the US and Japan].”
Elsewhere, three annexes to ICH Q4B, covering tablet friability, dissolution and polyacrylaminde gel electrophoresis reached step 4 of the harmonisation process, while two further annexes on capillary electrophoresis and analytical sieving moved to stage 2.
Q8, 9 and 10 training
Progress was also made on the ICH’s efforts to develop a training programme for workshops on ICH Pharmaceutical Development (Q8), Quality Risk management (Q9) and Pharmaceutical Quality System (Q10).
These were developed by the International Conference on Harmonisation (ICH) in an attempt to create a risk and science-based approach to quality and encourage continuous improvement.
The ICH said: “As these concepts and principles are rather new in the pharmaceutical area, it is important that, due primarily to departure from the traditional approaches to quality guidance, proper implementation of these concepts is provided by bringing clarity, further explanation and removing ambiguities and uncertainties.”
The workshop sessions, held Brussels, Belgium next June and in Washington DC and Tokyo, Japan the following October and November, will include case studies to illustrate the four phases of a drug product’s life cycle to which the guidelines apply.
The Q&A document issued by the ICH earlier this year can be found here.