Topics The 8th Regulatory Affairs Committee Symposium" held
On February 18, 2020, the 8th Regulatory Affairs Committee Symposium titled "Considering what can be done for more efficient face-to-face advice and review" was held at the Nomura Conference Plaza Nihonbashi (Chuo-ku, Tokyo). In planning the development of a new drug, the position of a company that maximizes the use of limited resources to promote efficiency and the position of the regulatory authority that conducts scientific evaluation and takes appropriate post-marketing measures after an application for approval are different, but we believe that they share the same philosophy of delivering effective and safe drugs to patients as quickly as possible. Therefore, the JPMA Regulatory Affairs Committee has been planning a forum for industry, academia, and government to discuss various issues in the development and review of new drugs together, and this is the 8th such meeting. This year's symposium was open mainly to member companies of the Regulatory Affairs Committee, and approximately 80 people attended. At the symposium, participants actively exchanged opinions with people from the Pharmaceuticals and Medical Devices Agency (PMDA), aiming for higher quality and more efficient face-to-face advice and review in light of recent pharmaceutical trends.
The venue
Introduction
The fourth mid-term goal of the Pharmaceuticals and Medical Devices Agency (PMDA) is to maintain the world's fastest review period for new drugs and to further improve quality. In terms of shortening the review period, PMDA has continued to achieve the target total review period of 80% tile value, which is 9 months for priority review items and 12 months for regular review items. As for the fourth mid-term goal of conducting appropriate consultations in response to domestic and international guidelines, various consultation slots have been newly established, and the operation method is considered to have been established to a certain extent. The Regulatory Affairs Committee's Regulatory Affairs Subcommittee regularly conducts a "Questionnaire Survey on Companies' Current Awareness of Face-to-Face Advice" and a "Questionnaire Survey on the Review Status of New Drugs". The results of the survey showed a high level of satisfaction with the results of face-to-face advisory consultation.
On the other hand, the results of the aforementioned questionnaire revealed new issues regarding the timing of face-to-face advice in Japan and the content of the consultation record, as global development progresses. In addition, many respondents expressed their desire for improvement in the fact that the timing of issuing important inquiries is still concentrated around the time of the expert consultation in the latter stages of the review process. In particular, the short timeframe between the expert consultation and the Pharmaceutical Affairs Committee (PAC) for inquiries about attachments and risk management plans (RMPs) is a major burden for applicants.
In light of recent JPMA trends, the Regulatory Affairs Committee of the JPMA has decided to establish a new committee, "More Efficient Advice and Review Process," with the aim of discussing what issues each side of the review process and the applicant side face and how to improve the process in order to achieve high-quality and more efficient review while maintaining the world's fastest review period. The symposium was organized under the theme of "What can be done to make the process of face-to-face advice and review more efficient?
The symposium was moderated by Yuji Kashitani, Chairperson of the Regulatory Affairs Committee's Subcommittee on Application and Regulatory Affairs, and Masakazu Suzaki, Chairperson of the Regulatory Affairs Committee, gave opening remarks as the organizer of the symposium. The first half of the symposium consisted of informative presentations by the PMDA on the results of its questionnaire on new drug review and new consultation items for FY2020, as well as a report on the results of the JPMA's questionnaire. The group discussions were facilitated by regular and deputy members of the Subcommittee.
Information: Report on PMDA Questionnaire Results, New Consultation Items and Registry Consultation, etc.
Under the title of "Results of PMDA New Drug Review Questionnaire and New Consultation Items for FY 2020," Kenichi Mikami, Director of the PMDA's Review Management Division, gave a presentation on the results of a questionnaire survey conducted in June and July 2019 targeting personnel in the New Drug Review Division and new consultation items to be introduced in FY 2020 (FY 2020). The results of the questionnaire survey showed that the initial interview is the most important part of the initial consultation process.
The results of the questionnaire survey focused on the initial interview, inquiries, review timeline, expert consultation, review reports, examples of the use of electronic application data, and material confirmation. In addition to in-depth content such as the criteria for holding the initial interview, specific guidelines for the review timeline, and selection of expert committee members, there were also comments on good responses from the applicant side and points that need to be improved, In addition, opinions were presented on what was done well by the applicant and what needs to be improved. In addition, the JPMA explained the new consultation items to be introduced in FY2020, including consultation on the utilization of pharmaceutical databases, development pipeline interview, and consultation on innovative manufacturing technologies for pharmaceuticals.
Mr. Kenichi Mikami, Director, Review Management Department, PMDA
Information: Report on the results of the JPMA questionnaire (consultation)
Hironori Takayama, sub-leader of Group 1 of the Regulatory Affairs Committee's Regulatory Affairs Subcommittee, presented the results of the face-to-face advice survey conducted by the Regulatory Affairs Committee in 2019 under the title "Report on JPMA Survey Results (Consultation)," including a comparison with the results of past surveys conducted regularly since 2006. The results of the survey were compared with the results of the past surveys conducted regularly since 2006, and the overall and individual cases of face-to-face advice were introduced. While the level of satisfaction with face-to-face advice remained high, new issues were raised due to the advancement of global development, such as the timing of consultations with regulatory authorities in other regions and whether to include advice based on assumptions and hypotheses in the consultation record.
Information: Report on the Results of the JPMA Questionnaire (Review)
Under the title of "Report on JPMA Questionnaire Results (Examination)," Natsuko Hamada, Sub-Leader of Group 2, Regulatory Affairs Committee, presented the results of the questionnaire survey on the status of approval review of new drugs and new regenerative medicine products conducted by the Regulatory Affairs Committee in 2019 and on the new drug review conducted at the PMDA. He introduced the opinions summarized from the applicant's point of view on the results of the questionnaire. The issues for streamlining the review process, etc. in terms of inquiries, review process, material confirmation, etc. were summarized, and both short-term and long-term proposals for win-win situations between the reviewer and applicant sides were presented.
Regulatory Affairs Committee, JPMA
Section 2, Group 2
Natsuko Hamada, Sub Leader
Group discussion
All the participants of this symposium were divided into six groups, with Mr. Mikami from the Review Management Division, Mr. Daiki Okuda, Section Chief, Mr. Yasuto Ohtsubo, Assistant Examiner, New Drug Examination Division 2, Mr. Tamji Nakanishi, Examiner, New Drug Examination Division 3, Mr. Tsune Koike, Examiner, New Drug Examination Division 4, and Mr. Yoichi Kono, Examiner, New Drug Examination Division 5, from the PMDA. The group discussions were facilitated by the regular and deputy members of the Subcommittee on New Drug Application Regulatory Affairs, and the common issues identified from the results of the consultation and review questionnaire were discussed.
The following four themes were exchanged as common issues identified from the survey results, and each group presented their discussions at the end of the session.
Examination
- 1.Improvement of the review process: Timing of expert consultation
- 2.Goal of the initial meeting: To better understand the review policy and the applicant's claims
Consultation
- 1.Who owns the consultation record: Advice based on assumptions and suppositions
- 2.Timing of PMDA consultation: in comparison with overseas regulatory authorities (US Food and Drug Administration (FDA)/European Medicines Agency (EMA))
First, in the discussion on the improvement of the review process, the applicant side presented the difficulties encountered when inquiries requiring important decisions on efficacy and package inserts are issued after the expert consultation, as well as suggestions for improvement, such as bringing forward the expert consultation and methods to grasp the discussions at the expert consultation earlier. In response, PMDA, while showing a certain understanding of the applicant's opinion, explained the risks of holding the expert consultation early and the cases in which it was difficult to coordinate with the expert committee members. However, the PMDA has been discussing important inquiries at an early stage of the review process, indicating that the applicant and the review team have a common understanding of the issues involved in the review process.
Next, in the discussion on the goal of the initial interview, while many respondents agreed that the initial interview is effective to deepen the understanding of the review policy and the applicant's arguments, others felt that it is not necessary if the review issues are sorted out in the pre-application consultation, and that the PMDA's decision not to conduct the interview is a relief for the applicant because it leads to the prospect of approval. On the other hand, there was an opinion that it is not necessary if the issues for review are sorted out in the pre-application consultation.
In the third discussion on the consultation record, it was explained that PMDA mainly summarizes its views on the consultation items as the record, and that the contents of the discussion on the day, especially advice based on assumptions and suppositions, are not recorded, considering the possibility that they may be affected by changes in the environment in the future. The consultants expressed their opinions on the importance of consultation records, especially in global development, and their request for advice in case of non-acceptance, and it became clear that when using consultation records strategically, it is necessary to fully consider how to assemble consultation items and how to conduct discussions on the day, etc., taking into account the background of the record preparation. It became clear that the way the consultation items are assembled and the way the discussions are conducted on the day of the consultation need to be carefully considered.
Finally, in the discussion on the timing of PMDA consultation, opinions were exchanged on the appropriate timing of consultation with overseas regulatory authorities (FDA/EMA) in international joint studies, including the appropriate order and information sharing, etc. PMDA commented that the order in Japan is often late and there are cases where changes are difficult after consultation with overseas authorities. The PMDA requested that the early consultation is desirable, and that the status of overseas consultations be shared for reference. Furthermore, it was explained that in some cases, information is exchanged with FDA and EMA, indicating consideration for international cooperation.
After the group discussion, the PMDA participants reaffirmed that smooth communication between companies and PMDA plays an important role for more efficient face-to-face advice and review. The participants expressed their opinion that the symposium was very meaningful in understanding each other's position and that they had a lively discussion that can be utilized to realize smooth communication in the future. Furthermore, it was hoped that the symposium would continue to provide an opportunity to exchange opinions in a flat manner in the future, and although this symposium was attended by the examiner class, it was suggested that the participation of the chief class be considered for the next symposium.
Group discussion and exchange of opinions
Concluding Remarks
This was the 8th symposium held by the Regulatory Affairs Committee, and a variety of topics have been discussed. This year's symposium took the form of interactive group discussions with PMDA staff, and many participants and PMDA have commented that the discussions were extremely meaningful. The Regulatory Affairs Committee will continue to contribute to the promotion of new drug development by each company through symposiums such as this one, as long as there are issues to be considered in light of development trends and regulations, and in turn, contribute to providing effective and safe new drugs to patients as quickly as possible.
( Zayko Murata, Regulatory Affairs Committee)