More Talks Needed With China and Japan For Cooperation In Sharing Clinical Data - Korea FDA Official

SEOUL - Although drug regulatory officials from South Korea, Japan and China met in Beijing for two days from Dec. 17 in their second tri-party meeting, they failed to report "noticeable progress" in their pursuit of an integrated clinical trial data-sharing program and mutual acceptance of their rules and guidelines, according to Korea FDA.

"To tackle different data from clinical trials and other studies, which are currently produced separately by the three countries, we talked and tried to agree on the development of an integrated data service, but we failed to do that - in part - because of China's unclear position to ICH," Yoo Tae-Moo, director of Drug Approval and Review Management Division of Korea FDA told PharmAsia News.

"Unlike Korea and Japan, China did not have a clear position regarding ICH, thus we failed to make some progress during the meeting in Beijing although we shared the view that the three countries should study together the possibility of racial differences of the three countries in clinical studies," said Yoo, noting that approval to commence trials in China was a long and complicated process.

The International Conference on Harmonization is a joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of drugs.

Although Korea, China and Japan are seeking ways to integrate sharing clinical trial data and mutual acceptance of data, the talks did not trigger any negative impact toward Korea's position toward attracting more clinical trials in the country, Yoo said.

"South Korea's infrastructure for clinical trials is quite unchallenged because it is well armed with high-quality and well-trained researchers," said Yoo, adding that the country's competitive edge witnessed in the state-of-the-art trial facilities in local hospitals is being benchmarked even by Japan.

Three-Country Talks Unlikely To Hamper Korea's Edge In Clinical Trials

South Korea stepped up a drive to host more clinical trials five years ago by selecting 12 large general hospitals across the country as clinical trial centers. Hospitals attached to prestigious academic centers, including Seoul National University and Yonsei University, have invested KRW 4 billion ($2.87 million) per year in clinical trials centers. The Korean government is matching those funds and is giving each hospital KRW 4 billion annually for five years (Also see "As Korea Steps Up Drive To Attract Global Clinical Trials, American CRO Opens Outpost In Seoul" - Scrip, 27 Jul, 2009.).

South Korea continues to draw more Phase I and Phase II clinical trials, and has already established a foothold in Phase III and post-approval trials, according to the Korea National Enterprise for Clinical Trials.

"Until 2006, Phase III were the main clinical trials we had done, but we began to undertake [more] Phase I and Phase II trials beginning in 2007 as our clinical trial level and standards became recognized," KoNECT President Shin Sang-goo told PharmAsia News (Also see "South Korea Beefs Up Infrastructure To Lead Asia In Early-Stage Clinical Trials" - Scrip, 12 Feb, 2009.).

Proposed by Japan in 2008, the annual meeting of China, Japan and Korea was hosted by China's State FDA in December and drew more than 20 representatives from SFDA, Japan's Pharmaceutical and Medical Device Agency and Korea FDA (Also see "Japanese Regulators, With Drug Makers Support, Moves Toward East Asian Clinical Data Sharing And Acceptance" - Scrip, 11 Jan, 2010.)

The meeting continued discussions from the first round held in Tokyo, which addressed the ethical differences among patients in the three nations where members agreed to continue research efforts (Also see "East Asian Regulators Collaborate To Reduce Drug Lags (Part 1 of 2)" - Scrip, 17 Apr, 2008.).

Due to genetic and disease similarities, multi-regional clinical trials conducted in Asian countries including Japan are increasing. According to meeting presenter Seiji Miyazawa, director of International Affairs at Japan Pharmaceutical Manufacturers Association, the number of multi-regional clinical trials conducted in the region increased six-fold in three years, from two in 2006 to 12 as of November 2009.

Of the 400 clinical trials South Korea drawn in 2008, 216 were multi-regional clinical trials, KFDA's Yoo added.

The third round of clinical trial talks will be held in South Korea this year.

- Peter Chang ([email protected])