DRUG DISCOVERY & DEVELOPMENT 37
as regulations that require the use of clinical data from native populations. Te time required to navigate regulatory environments can cause delays costing billions of pounds in potential lost sales.
Some of the aforementioned opportunities have come about as a result of changes in the Chinese, Taiwanese, Japanese and South Korean regulatory environments, which now allow for biopharmaceutical companies to incorporate Asian countries into the early stages of drug development programmes and speed up product introduction into these growing markets.
Via ‘ethnobridging’, companies developing drugs in Europe can collect and analyse data from native Asians living in other countries to employ cost-effective, multi-ethnic approaches to clinical trial programmes.
Regulatory changes Although regulatory changes have made ethnobridging more practical, the concept isn’t a new one. In 1998, the International Conference on Harmonisation published guidance on ‘Ethnic Factors in the Acceptability of Foreign Clinical Data’.
Te guidelines recommended regulatory and development strategies on the use of clinical data collected in one region to support drug and biologic registrations in another, a condition being that ethnic factors were addressed using bridging studies.
Te E5 guidelines facilitated drug and biologic registration among ICH regions by recommending a framework for evaluating the result of ethnic factors on a drug’s effectiveness and safety.
Recommended regulatory and development strategies would
allow for sufficient evaluation of the impact of ethnic factors, reduce clinical study duplication and accelerate the drug approval process.
At the time, the difficulties involved in sending clinical data to Japan were noted.
Although pharmaceutical organisations could make use of data generated in the West, they would still need to supply bridging or comparative studies between Japanese and Caucasian trial patients.
Te premise of this was sound; however, collecting data on Caucasian participants in Japan proved near-impossible due to the ethnic makeup of Japan and the pharmaceutical industry’s limited success with initial bridging pharmacokinetic (PK) studies.
As a result of this, the Japanese Ministry of Health and Welfare was engaged to discuss how companies could go about conducting studies outside of Japan with Japanese natives.
By 2005, interest in performing global trials that involved Asian
countries at an early stage had increased considerably. At this time, European, Japanese and US pharmaceutical companies began designing trials, starting in Phase I, which included Asian countries.
Ethnic data In 2007, Japan, Korea and China began to co-operate on clinical development issues. Regulatory authorities in Japan led this effort and started accepting Phase II/III and efficacy data from other Asian countries in lieu of Japan-only data as long as pharmacokinetics were the same between Japanese and Chinese and/or Koreans. Regulatory authorities in China began to request ethnic Chinese data for global trial participation.
Although the Chinese Food and Drug Administration (CFDA) has always required Chinese PK data for product registration in the country, it has not always required Chinese Phase 1 data for global trials participation. Tis has begun to change as regulatory bodies in China follow the Japanese example and ask for Chinese PK data to enjoin global trials.
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Biopharmaceutical companies are now able to incorporate Asian countries into the early stages of their drug development programmes.
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