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Country Specific Regulations – Global / International Trial


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:

CountryRegulatory AuthorityTime to review & approve a clinical trial application (Wks)Time to review/approve a New Chemical Entity (NCE) (Mos.)Local Trial Required for Approval?Local Post-Market Safety Studies Required?
AustraliaTherapeutic Goods Administration (TGA)18 [ethics = 12-16 + regulatory = 2]13-15NoYes
ChinaChina Food and Drug Administration (CFDA)64 [regulatory =  40-56 + ethics = 4-8]21-25YesYes
IndiaDrug Controller General of India (DCGI)24-32 [parallel; regulatory = 16-18, ethics = 6-10]12YesYes
JapanMinistry of Health, Labor and Welfare (MHLW)4.3+[regulatory = 4.3+ethics]12YesYes
New ZealandNew Zealand Medicines and Medical Devices Safety Authority (Medsafe)4-6 [parallel; regulatory = 4-6, ethics = 4-6]11NoNo
South KoreaMinistry of Food and Drug Safety (MFDS)8 [parallel; regulatory = 8, ethics = 6-8]10-12YesYes
Note: Dossier type is ICH for all countries listed above.

Author

Post author

Ernie Sakchalathorn

Polachai Ernie Sakchalathorn is the founder of ClinicalResearchAssociateCRA.com and has been in clinical research since 2007. While he is no longer affiliated with the website or benefits financially from site operations, he still remains a professional in the clinical research space and currently serves as a Clinical Affairs Manager at a medical device company.

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