This post was co-authored by Meenakshi Rao, Senior Director, Head of Regulatory Strategy, Strategic Drug Development, Quintiles Asia-Pacific.
We’re seeing more and more multinational companies ramping up their drug development in Asia by implementing strategies to optimize “resource-benefit-risk”; however they need to separate myths from reality. In our interactions with Western MNCs, we see a pattern of misconceptions. In this blog we’d like to identify those and provide a realistic view of the current state of regulatory systems in Asia (for a more in-depth look please see our article in Regulatory Focus magazine).
In learning about development in Asia, you can avoid making potentially costly mistakes by keeping these things in mind: avoid extrapolating from the practices of major countries; accepting dictates from influential lobbies as truths; and “over expecting” what major institutions can accomplish.
Myths vs. Reality
Myth: “Data exclusivity” means the same to the US and EU as it does to other countries, so if one country implements data exclusivity, generics cannot enter that market during that period.
- Reality: Data exclusivity means different things to people in different countries. The World Trade Organization’s “Trade-Related Aspects of Intellectual Property Rights” (TRIPS) Agreement of 1993 put in place protections on the use of use of undisclosed innovator-company data by generics makers. Influential lobbies from US and EU have extended the definition of data exclusivity to mean protection of any data (includes disclosed as well as undisclosed data) against unfair commercial use. However, not every TRIPs member country accepts this extended definition of drug exclusivity.
Myth: The “Tripartite Cooperation on Clinical Research” arising from the China/Japan/Korea collaboration is finalized and guidelines are in place, so clinical trials activities can be pursued to take advantage of the mutual harmonization currently in place.
- Reality: The China/Japan/Korea “Tripartite Cooperation on Clinical Research,” initiated in 2007 has been on the “back-burner” since October 2011 and not much has been accomplished in terms of harmonized, actionable plans. Although, one company has claimed success in leveraging the Tripartite Cooperation to implement an accelerated development strategy—until official Tripartite consensus and guidelines are in place—pharmaceutical companies will have to continue to navigate and implement drug development and regulatory strategies appropriate to the nature of the drug and according to the needs of each country.
Myth: Currently, there are no notable intra-Asian regulatory collaboration activities other than Asia-Pacific Economic Cooperation (APEC) initiatives (and follow-on Tripartite Working Group of China, Korea and Japan, currently on the backburner), and the Association of Southeast Asia Nations (ASEAN) harmonization activities on pharmaceutical products.
- Reality: Besides the Tripartite Agreement and the ASEAN harmonization, there are other intra-Asian regulatory collaborations, such as the “Comprehensive Economic Cooperation Agreement” between India and Singapore, and the “Cross-Straits Economic Cooperation Framework Agreement” between Taiwan and mainland China. Taigexyn® (nemonoxacin) was submitted—with obvious great expectations—to the CFDA under the “Cross-Straits Economic Cooperation Framework Agreement”.
Myth: To be successful in Asia, it would be best to copy what successful innovators (or approved “follow-on” products) have done in terms of formulating patient numbers and clinical trial design.
- Reality: Although patient numbers are often recommended by authorities through various guidelines, clinical trial design also depends on multiple factors which will impact each manufacturer (e.g., of a biosimilar) differently. With so many variable factors to consider, it would be a mistake to simply follow the clinical program of an already registered biosimilar.
Myth: Ethnic sensitivity, in terms of drug response, needs to be shown in all markets, especially given the racial or genetic diversity in Asia. As a consequence, localized clinical trials are mandatory for most countries in Asia.
- Reality: Ethnic sensitivity, i.e. differences in a person’s response to a drug—in terms of both efficacy and safety—based on ethnicity, is an important parameter to consider for drug development in Asia. This concern has led to the creation of the ICH E5 Guidelines on “Ethnic Factors in the Acceptability of Foreign Clinical Data.” Although some countries require “local” clinical data to address the question of ethnic sensitivity, there may be room for flexibility afforded by local guidelines.
Myth: The therapeutic class of drug is a major factor in determining the regulatory pathway of a drug developed in Asia.
- Reality: Regulatory pathways are distinct from and not largely dependent on therapeutic classes in Asia. By and large, the therapeutic class of drug is not the main factor for determining regulatory pathways in Asia. However, there are exceptions based on each country’s medical needs.
Myth: If we include ethnic Chinese patients or subjects from territories outside China, this could fulfill the requirements for drug development in China.
- Reality: Unless there are special circumstances or permission granted, CFDA will only accept Asian data from territories outside China as supportive data. The data in and of itself, even if consisting purely of overseas ethnic Chinese, will be insufficient for fulfilling local requirements. However, the reader is well advised to monitor the fast-changing regulatory environment in China.