Emerging markets: Acceptability of data generated from foreign clinical trials and ethnic factors in drug development
23rd-24th November 2009, Geneva, Switzerland
The majority of medicines are not currently developed for exclusive use in one country, and there is a continuing debate on how best to use clinical data that are obtained from global studies so as to avoid duplicative testing, delayed availability, and increased cost of development.
As the regulation of medicine should be based on scientific pinciples, it is these that should be at the forefront of any discussion on acceptability of foreign data. When considering foreign clinical data, regulators will be checking to see that
- the data are relevant to their country’s environment from a clinical perspective
- studies have been conducted to appropriate standards
- the evidence package is sufficient to meet the regulators’ criteria for a registration of a new medicine
- and that there are no issues of differing response relating to the ethnicity between the population studied and the local population.
There are a number of countries that require local clinical trials for registration as a pre- requisite for marketing the drug in the country, such as China and India, as well as countries that require bridging studies, such as Japan, South Korea and Taiwan. The International Council on the Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E5 guideline was intended to establish a framework through which agencies could assess whether efficacy or safety data from other countries could be used to make regulatory evaluations in their own jurisdictions. It has now been over 10 years since the ich E5 guideline (Ethnic factors in the acceptability of foreign clinical data) was signed off under the auspices of ich and the guideline is still interpreted differently by different countries.
Many countries are actively investigating the relevance of ethnic factors to the way medicines are used by their constituents. Currently Japan is being proactive in looking to encourage companies to include Japan in global trials. There is also an initiative to evaluate clinically relevant differences between Asian populations, with China, Japan and South Korea in discussion about undertaking studies to identify if there are any clinically relevant differences in data generated from patients in their respective countries. In Taiwan and South Korea, the agencies have identified which products require bridging studies and for which ones a company can obtain a bridging waiver. In the future, there are concerns that individual countries might increase their requests for additional data to be generated in their country or region. As more companies undertake trials outside of Europe and USA, these regulatory authorities are becoming more conscious that companies may be submitting dossiers that will predominantly include data from clinical studies conducted outside the ICH countries. Matching the regional sensitivities with the limitations of global clinical programmes will be a challenge to be overcome.
This workshop was held to move forward the discussion on this topic, not just to evaluate 10 years of the E5 guideline, but to understand the current perspectives of agencies and companies on the use of foreign data and to look to the future and identify the framework that agencies should be using when interpreting foreign clinical data.