Are the ICH New Principles of Governance Agreed at Fukuoka a Power Grab by the Regulators?

The change (detailed below) initially looks like a power grab by the regulators and I am sure many will paint it in this light. However, I see it as a correction to the power balance at the ICH, the ICH has come under criticism for being industry lead and controlled, the guidance produced having a detrimental effect of global trade. In addition as the guidance is produced by the ICH and filters down through the member regulatory systems into law, and in non ICH member states who perceive it as a gold standard, tough standards become very hard for small local manufactures to meet. These smaller manufactures often provide generic drugs for local markets in less developed countries. So are squeezed out of their own markets and most definitely kept out of ours.

In effect the industry influence at the top of this funnel was seen as detrimental and protectionist, I believe the WHO have commented on this in the past, they are a non voting observer of ICH procedures, this re-balancing of ICH will be central to tackling this probably valid criticism.

Also as industry partly pays for ICH and votes on its policies thought industry associations they must have accepted the change or it would not happen.

The Details

The six official ICH parties have agreed on new principles of governance which better define the roles of regulator and industry parties within ICH. This action will highlight ICH’s longstanding premise that the regulators have the ultimate responsibility in ensuring the protection of public health, in addition to their competence to issue regulatory Guidelines.

ICH will continue to be consensus driven, and strive to remain at the cutting-edge of scientific and technical developments in the pharmaceutical area. This will require the continued close cooperation between regulatory and pharmaceutical industry experts that has been instrumental in providing the best scientific and technical input in the development of ICH products, but with some changes. In the future, EWGs will be chaired by a representative of the regulators who will be responsible for ensuring regulatory oversight as well as integrity of the entire process. In addition, the current four step ICH procedure for work products will be reviewed to provide a clear distinction between the collation of scientific and technical information into a “technical document” by the experts, and the development of this document into a regulatory ICH Guideline by the regulators.

In circumstances when regulators and industry may not have the same interests or priorities with respect to a particular harmonisation activity the new principles allow ICH to proceed with a proposed topic for harmonisation provided it is supported by the three ICH regulatory parties, irrespective of whether or not this topic is supported by the industry parties.

The current Step 3 procedures of public consultation within the three regulatory parties, as well as through ICH, Observers and WHO contact points, will be maintained. Transparency will be further increased through the publication of Nigerian Music¬†information about the ICH process on the ICH website, including publication of “technical documents.” These principles will be incorporated into revised Rules of Procedures which are due to be adopted at the next meeting of the ICH Steering Committee.

Damien Bove –

Damien has worked in the pharmaceutical industry for over 15 years, first as a pharmaceutical technician and than an academic research manager at SmithKline Beecham before completing his university education. Damien graduated from the University of Bradford School of Pharmacy in 2000, he also has a masters in the Frontiers of Medical Science, and has since pursued his carrier in the development of novel drug/biological product development.

His work has seen him frequently present projects to the MHRA, EMEA and FDA, and prepare development programmes aimed at attracting investors. Damien has enjoyed significant success in helping companies raise finance, with a almost 100% success record in the companies he advises going on to raise the necessary finance to more their projects forwards.



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