eCTD Adoption Among Major Reforms Underway in China Pharmaceutical Market

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The economic growth and modernization that transformed China in the last generation is unprecedented. Starting in 1979, the country average nearly double-digit GDP growth until a slowdown took hold in recent years.

China’s rise in the biopharma industry has been equally dramatic. In 2014, China supplanted Japan as the second largest market in the world, trailing only the United States. By 2020, the market is projected to double again.

If history is any indication, the China Food and Drug Administration’s (CFDA) adoption of eCTD will also outpace anything previously seen at other regional health agencies.

Moving to eCTD submissions is just one of many initiatives currently underway in China as part of an effort to reform regulation of the pharmaceutical industry.

Economic growth is seen as the catalyst for these major reforms.

In a speech at the National People’s Congress Standing Committee, Bi Jingquan, head of the CFDA, explained how the nation’s rapid economic rise exposed flaws in the regulatory process and why reforms are needed. The shortcomings are affecting the development of new therapies as well as the quality of generic drugs on the market.

The two central tenets of proposed reforms are incentivizing research and improving quality standards of generic drugs.

Incentivizing Research

A current and longstanding rule states that only manufacturers can apply for drug approvals in China. This practice may unintentionally stifle research organizations by forcing them to either invest heavily in establishing a manufacturing facility or transfer their discoveries to existing manufacturers.

Quality Standards

Current standards allow for lesser quality generic drugs to be sold in China as compared to products in other markets. Under the proposed reforms, generic drugs will meet international standards for quality and efficacy, thus ensuring generic drugs available for sale in China are consistent with the characteristics of their reference products. A document outlining proposed changes is currently open for comment. This is the latest initiative tied to the approval process for drugs in China.

The rapid growth of the market coupled with reforms has impacted the approval timeline as requirements are being added, increasing the time for reviews. The industry has noticed an ongoing trend of longer approval cycles.

“It takes much longer now to get products approved,” Johnson & Johnson’s Chief Scientific Officer Paul Stoffels said in an interview last January at the World Economic Forum in Davos, Switzerland. Historically, drugs developed through international clinical trials took about two years for approval in China. That timeline may double according to the industry group R&D-Based Pharmaceutical Association Committee (RDPAC).

The CFDA also pointed out that the backlog of drug applications awaiting approval has increased. In response, additional international standards are being adopted, such as the CTD format.

If all goes well, implementing a sophisticated system for reviewing eCTDs and dramatically increasing the number of review personnel at the CFDA will pave the way to a modern, efficient pathway for application review and a shrinking backlog of applications.


Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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