Japan's New Regulatory Attitude Evident at DIA EuroMeeting
One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.
What he went on to say was both surprising and refreshing, coming from a representative of PMDA. He said that he had wondered what he would wear if he didn’t get his luggage in time for the session. In the end, even though he had been reunited with his clothing in time, he decided to wear the PMDA T-shirt to foster an informal atmosphere for the session, which he hoped the audience would find acceptable. This last sentiment was met with an enthusiastic round of applause from the hundreds in attendance, many from big pharma.
Clearly the message PMDA wanted to send during its session was that the agency is striving for openness, cooperation and timeliness to promote Japan’s role in global drug development.
Both Uyama and Satoshi Toyoshima, Ph.D., executive director and director, Center for Products Evaluation at PMDA, discussed many objectives and initiatives to accelerate the drug process in Japan, but the initiative that will have the most immediate impact will launch in April. With the new Investigational New Drug Application (IND) Consultation Process, PMDA wants to increase the number of face-to-face meetings with sponsor companies and also meet with them in a more timely manner.
Uyama noted that in 2006 there were 473 sponsor applications for IND consultations with PMDA, with only 295 actually granted. PMDA wants to increase the percentage of consultations granted to those sponsors that apply and has a tentative plan that Uyama shared with the DIA EuroMeeting audience. From April forward, the new IND consultation process should have a predictable schedule of about five months, during which sponsors are able to submit an expression of intention, apply and submit documents to PMDA.
Five weeks prior to the face-to-face meeting, there will be an inquiry and response period between sponsors and PMDA. Four days prior to the face-to-face meeting, PMDA will give its opinion, which will be discussed at the meeting. Draft minutes will be drawn up and then finalized one month after the meeting.
Clearly the message PMDA wanted to send during its session was that the agency is striving for openness, cooperation and timeliness to promote Japan’s role in global drug development. PMDA also wants its entire New Drug Approval Process to take only one year between the primary meeting between the sponsor and PMDA approval.
The question-and-answer period proved especially lively with big pharma asking questions that struck a chord with many there.
One audience member asked whether PMDA had considered having more data summaries provided in English, to which Toyoshima responded that “the current situation is we accept CTD [clinical trial document modules] 3, 4, 5 in English and CTD 1 and 2 in Japanese because they are available to the public. We have a responsibility to the public to explain why a drug is approved. From the Japanese perspective, we try to keep transparency with Japanese public. Module 2 is very important for Japanese reviewers, so it’s in Japanese not in English.”
A representative from AstraZeneca asked: “When will we start to see improvement in approval times?” Uyama answered that it will hire approximately 80 new reviewers by April and another 150 after that. But they need training.”
It clearly will take some time.
A representative from GSK asked the billion-dollar question: “How many Japanese patients are enough in global clinical trials?” The representatives from PMDA were non-committal on that one, saying that it was an issue to be discussed during IND consultations. Later they mentioned that if a global clinical trial included enough Japanese patients, then no bridging studies would be needed. That seemed to be the goal, until I asked the panel if PMDA wanted to get rid of bridging studies altogether.
All things considered, the answer was no.
But, it does seem to be moving in that direction. It is at least an option in one of the three possible scenarios the agency illustrated. It seems that PMDA wants to consider clinical trials, applications and approvals on a case-by-case basis, rather than standardizing some requirements, which will make for a very labor-intensive process in the short term.
One can only hope that PMDA’s desire for openness, with its accompanying increased staff requirements and face-to-face meetings, will be an interim step toward the goal of a real mutual understanding between sponsors and PMDA.