The Impact of Implementation of ICH Guidelines in Non-ICH Countries - Regulatory Support Series No. 009
(2002; 34 pages) View the PDF document
Table of Contents
View the documentExecutive Summary
View the document1. Introduction
View the document2. WHO'S role in developing global standards for pharmaceutical products
View the document3. The International Conference on Harmonisation (ICH)
View the document4. Expanded ICH initiatives
Open this folder and view contents5. Implications of the ICH process and globalization of ICH guidelines
Close this folder6. Implication of the use of ICH guidelines by non-ICH drug regulatory authorities
View the document6.1 Efficacy and safety
View the document6.2 Quality
View the document7. WHO guidelines for generic drugs
View the document8. Challenges for WHO
View the document9. Recommendations to WHO
View the documentAnnex I - List of Participants

6.2 Quality

In the field of drug quality ICH has produced 15 guidelines describing technical requirements related to the process of registration of new chemical entities and products obtained by biotechnology. Again, the scientific level of each guideline is high and reflects state-of-the-art technology.

Guidelines related to drug quality may also be of use to non-ICH countries to create awareness of the subject and for reference purposes for national drug regulatory authorities when producing national legislation. They may also be used for training purposes, especially to trigger discussion on approaches to setting quality standards.

However, ICH has relied increasingly on advanced pharmaceutical technology in its standard setting, on the assumption that this technology will lead to greater safety of new drugs, while the ICH guidelines relating to drug quality have introduced a general tightening of specifications for pharmaceutical starting materials. For example, ICH guideline Q3A ("Impurities in new drug substances") includes the requirement that each organic impurity (whether identified or unidentified) present in a substance in the amount of 0.1% or more (in some cases 0.05% or more) should be considered as a qualified impurity (i.e. its safety should be established). This raises the question of the basis for the selection of the borderline figure, as the additional safety benefits from these rigorous standards have not been demonstrated but the costs incurred by manufacturers in meeting the requirements are significant.

Setting such norms may have considerable repercussions on current manufacturing practices, as only pharmaceutical companies with substantial resources can achieve the necessary standards. This is a concern if the guidelines are intended for global application. Smaller pharmaceutical companies, generic companies and many larger companies responsible for essential drug production in developing countries may be effectively squeezed out of drug manufacturing if ICH guidelines start to be interpreted as the only global standard. For example, the ICH guidelines Q3A ("Impurities in new drug substances") and Q3C ("Impurities: guideline for the residual solvents") were developed for new products but their application has been extended by the European authorities to cover all products registered in the European Union.

Another type of difficulty has arisen with ICH guideline Q7A, on "Good Manufacturing Practice guide for active pharmaceutical ingredients". The guideline introduces and expands the requirements for manufacturers of pharmaceutical active starting materials, and so creates increased rigidity in the starting material supply system, with consequent effects on starting material prices and availability. The applicability of this guideline for non-ICH countries has been questioned.

Although formally the Pharmacopoeial Discussion Group (which consists of representatives of the three pharmacopoeias of the ICH countries) acts outside the ICH system, in practice its activities are closely linked to ICH's activities. Of special importance is the acceptance of the requirements included in ICH guidelines Q3A and Q3C (see above), which are gradually being introduced into pharmacopoeia monographs published in the ICH countries.


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