Success Story - To Japanese Market with CoreMed

Company A, a non-Japanese company, had no presence in Japan when they started working with CoreMed. CoreMed served as their local regulatory affairs team and worked together towards the approval. Company A is now Marketing Approval Holder (MAH) in Japan and expanding their organization.

Gap Analysis
Clinical development was on going including Japan, but nothing was prepared for the J-NDA at that time. So, CoreMed conducted gap analysis for the J-NDA firstly based on their overseas CTD and advised what to do for Japan.

Pre-NDA meeting with PMDA
One of the most important things was a pre-NDA meeting with the PMDA. CoreMed organized the meeting with the PMDA on behalf of Company A and obtained agreement with the PMDA regarding the Clinical Data Package.

J-NDA (CTD) preparation
CoreMed prepared CTD modules 1 thought 5. Japan has specific requirements and writing style although ICH CTD guidelines have been implemented in Japan. We provided Company A with such information and collaborated to rewrite Modules for Japan. We had regular TCs and Face-to-Face meetings as needed.

In parallel, CoreMed submitted an application for Japanese Accepted Name (JAN) which must be granted before the J-NDA for new molecular entity. Furthermore, we advised regarding Foreign Manufacturer Accreditation (FMA) which is also mandatory for the J-NDA.

In addition to the CTD, other documents are required for the J-NDA, such as documents required for Compliance Inspection, GMP inspection. CoreMed helped them prepare these documents.

Orphan Drug Designation (ODD)
CoreMed supported Company A to obtain ODD.

Marketing Business License
In order to be the Applicant of the J-NDA, Company A had to establish a Japanese legal entity with Marketing Business License. CoreMed advised requirements to be the Applicant (MAH).

Pre-submission meeting with the PMDA
Before the J-NDA submission, CoreMed accompanied with the Japanese subsidiary of Company A to meet the PMDA to discuss the timeline and other administrative matters regarding the J-NDA review process.

Review Process
CoreMed helped Company A respond to PMDA inquiries. We translated PMDA inquiries into English immediately after receiving them, and advised and discussed how to respond to the inquiries with Company A (via e-mail, TC). Then, we prepared responses (English and Japanese) including translation of responses. Sometimes, CoreMed discussed with the PMDA on behalf of Company A. We worked very hard together with Company A to meet the PMDA expectation and timeline.

Approval
The product was approved as scheduled. It was a great teamwork. Now, the Japan subsidiary of Company A has been well established and expanding their organization in Japan.

Business Alliances

  • Japan | eCTD | Digital Media Systems, Co. Ltd.
  • EU | Global Regulatory Consulting | Dr. Regenolod GmbH
  • SFL Regulatory Affairs & Scientific Communication Ltd.
  • Headquarters
    Tsunenari Bldg., 2-1-21, Kitahama, Chuo-ku, Osaka 541-0041, Japan
    (TEL)+81-(0)6-6221-1352
    (FAX) +81-(0)6-6221-1357

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  • Tokyo office
    KN Nihonbashi Bldg., 4-8-17, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023, Japan
    (TEL) +81-(0)3-5205-2757
    (FAX) +81-(0)3-5205-2758

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