Challenges in the Clinical Development Requirements for the Marketing Authorization of New Medicines in Southeast Asia

Abstract

A rapid growth of investment into clinical research and new drug development has manifested itself by an exponential increase of new products coming onto the worldwide market. The emerging pharmaceutical and biotech markets in Southeast Asia are believed to be extremely promising from a commercial point of view in the next decade. The unique position of the Asian market and the diversity in clinical research initiatives are linked with diverse regulatory requirements for clinical development and registration of new medicines. Some of these differences have an impact on timelines for marketing authorizations in South Korea, China, Thailand, Japan, Singapore, and other countries. One of the approaches to streamlining regulatory strategy in different countries is the initiation of multicountry international clinical trials trying to address requirements and allowing registration in several regional countries simultaneously. Increasing cooperation between South Asian countries in relation to regulatory requirements and clinical development will facilitate the registration of innovative medicines in this rapidly developing region of the world and enable improved cohesiveness between countries in a drug safety framework.

Key feasibility considerations when conducting vaccine clinical trials in Asia–Pacific countries

“…The biological market in the People's Republic of China is estimated to be growing at least 30% annually, while Japan represents approximately 7.3% of the worldwide pharmaceutical market. 9 Since Asia consists of both developed and developing countries, it has a large patient population with diseases of both the developed and developing world. This is in addition to the potential for cost savings and fewer competing trials as compared to North America and Europe.…”

“…8,10 The epidemiological profile of the Asian population is also unique due to its relatively high natural exposure to infections and naive immunological background. 9 This makes Asian countries an especially attractive place to study new vaccines with rapid recruitment of trial subjects.…”

The Importance of Ethnicity Definitions and Pharmacogenomics in Ethnobridging

“…Differences in patientephysician relationships between Western and Asian culture have also been highlighted, in which the Japanese/ Asian culture has been viewed as being more hierarchical and paternalistic [84]. The doctor is held in great respect to the point that patients sometimes do not report adverse effects so as to not be offensive to the doctor [85]. However, it should also be noted that recent findings in Japan show that the Japanese patients now prefer the mutual "Western"-style relationship, which may also be considered ideal in other Asian cultures [84].…”

“…For import drugs with a Certificate of Pharmaceutical Product (CPP) issued by the exporting country with a patent certificate and established Good Manufacturing Practice (GMP) status [102], foreign clinical data would then be assessed for completeness, in line with GMP requirements as well as the Chinese regulatory requirements and ethnic sensitivity assessment. Subsequently, a pharmacokinetic study and a clinical trial of 100 Chinese subjects (per arm) will be required [85,102]. Alternatively, the foreign applicant could submit a clinical trials application, in accordance with Article 44 of the Drug Registration Regulation [101], which states that the drug should already be registered in a foreign country or in Phase II development (however, this does not apply to applications for new vaccines, which are not registered in any country).…”

The New Political Economy of Pharmaceuticals

“…Government regulation of the pharmaceutical sector encompasses licensing, regular inspection of manufacturing premises and registration of drug products for the purpose of ensuring drug quality and safety (Kudrin, 2009). More broadly, government policies and regulations shape the business environment for local pharmaceutical production.…”