Dr Vesna Koblar, Slovenia

Harmonization of registration requirements leads to reduced replication of drug trials and shorter registration procedures, while maintaining the quality, safety, and efficacy of pharmaceutical products. The ICH initiative was started in 17 high-income countries, but it also has an impact on non-ICH countries, which account for 85% of the world’s population. Application of measures for public health protection in these areas is related partly to their affordability.

Although ICH was not initially intended as a worldwide cooperative effort, global standardization is an inevitable consequence of ICH. For this reason, a steering committee was established by the ICH Global Cooperation Group to make information available to non-ICH countries, seek their comments on and acceptance of ICH guidelines, and thereby expand the ICH idea.

Although the common ambition of ICH and non-ICH countries is the same, there are differences between the two groups, notably in the role of essential (generic) drugs, in the concept of satisfactory levels of quality, safety, and efficacy, and in what is affordable. Public health is the first concern in non-ICH countries, where the level of technical standards has to be justified by public health needs, not by the state-of-the-art technology.

The concerns of non-ICH countries include the need for harmonized standards of quality, safety, and efficacy, and appropriate regulatory requirements, rather than global application of ICH standards, which might be too high for local industry, leading to withdrawal of products with consequent negative effects on public health. In some countries, withdrawals could have a greater public health impact than acceptance of a drug that does not meet ICH standards. On the other hand, accepting a lower standard may lead to differences in regulatory approach, double standards for quality, safety and efficacy, and double standards for public health protection.

The solution may be harmonized regulatory standards that are applicable to developed and developing countries, perhaps with WHO collaboration. The alternative is to have a double regulatory standard, one for the rich, one for the less rich.

In conclusion, if the harmonized ICH regulatory requirements are to have a positive impact on non-ICH members, they should establish the same standards of quality, safety, and efficacy, improve drug availability, avoid repetition of trials, save resources and improve public health protection. They should promote the introduction of standards of quality, safety, and efficacy based on public health need rather than state-of-the-art technology. The approach should be reviewed by a coordinator for its global applicability, with a view to protection of public health.