As more and more clinical trials become globalized, regulatory pathways in different region and countries represent both opportunities and limitations in the continuation of this trend. One important point to bring up in global trial discussion is that outside of the European Union (EU), there is no harmonization of regulatory requirements among each country. Thus, country specific regulatory requirements are the rules governing clinical trial conducts and final product approvals.
Commercial Opportunities
Developing countries represent significant opportunities due to the large size of population (potential buyers of the product) in different regions of the world. In addition, the size of the market in some regions is growing rapidly. For example, Asian pharmaceutical market is already substantial, second only to that of North America. China, alone, is growing rapidly due to its vast population.
Non-Commercial Opportunities
In addition to commercial potential, developing countries also present non-commercial opportunities such as access to:
- New patient / disease populations
- New clinical trial sites
- Key opinion leaders (KOLs)
- New regions with potentially lower clinical trial cost
Consideration for Global Trial Site Selection
When considering global / international clinical trial site(s), manufacturers must consider the factors below:
- Which countries should (and should not) be included in global development plans
- When these countries should be involved, as each country requires different timelines for clinical trial approvals, completion, and regulatory and reimbursement decisions
- How the manufacturer should be involved in the end market use of the product in these countries. Examples include how the end product will be distribute, the cost of the product, and the unmet need in different countries
Country Specific Regulation
Efficiency and review process among countries are different, which lead to significant variation on regulatory pathways from country to country. Below are some examples of time for review and approval for a clinical trial application for some countries:
Country | Regulatory Authority | Time to review and approve a clinical trial application (Weeks) | Time to review/approve a New Chemical Entity (NCE) (Months) | Dossier Type | Local Trial Required for Approval | Local Post-Marketing Safety Studies Required |
Australia | Therapeutic Goods Administration (TGA) | 18 [ethics = 12-16 + regulatory = 2] | 13-15 | ICH | No | Yes |
China | China Food and Drug Administration (CFDA) | 64 [regulatory = 40-56 + ethics = 4-8] | 21-25 | ICH | Yes | Yes |
India | Drug Controller General of India (DCGI) | 24-32 [parallel; regulatory = 16-18, ethics = 6-10] | 12 | ICH | Yes | Yes |
Japan | Ministry of Health, Labor and Welfare (MHLW) | 4.3+[regulatory = 4.3+ethics] | 12 | ICH | Yes | Yes |
New Zealand | New Zealand Medicines and Medical Devices Safety Authority (Medsafe) | 4-6 [parallel; regulatory = 4-6, ethics = 4-6] | 11 | ICH | No | No |
South Korea | Ministry of Food and Drug Safety (MFDS) | 8 [parallel; regulatory = 8, ethics = 6-8] | 10-12 | ICH | Yes | Yes |
Source: Scheeren J, Woolley KL, Dang T, Opportunities and Challenges of Global Drug Development in Asia: Are you ready?, Regulatoryfocus.org, December 2013
Related pages
- European Medicines Agency (EMA)
- Food and Drug Administration (FDA)
- Historical Events behind Current Regulations
- ICH’s GCP Guideline
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