{"data":[{"id":"4fd7c9b3-b7fe-439c-86eb-6dbe318727a8","company_name":"臨薬協","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"行政指導","action_date":"2024-09-01","announcement_date":"2026-05-04","violation_summary":"医療機器の規制に関する提案や、添付文書の電子化、UDIの義務化、国際整合、規制調和、働き方改革とITシステムの活用についての提案を行っていること。","violation_summary_en":"The Ministry of Health, Labour and Welfare issued administrative guidance to the Japan Pharmaceutical Manufacturers Association on September 1, 2024, regarding proposals related to medical device regulations, including electronic labeling, UDI mandatory requirements, international regulatory harmonization, and reforms in working practices and IT system utilization.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_13968.html","url":"https://regbase.jp/enforcement/yakkiho-lin-yao-xie-20240901"},{"id":"5ce63840-8021-4e8d-81db-a3b68a643fe6","company_name":"臨床薬理協会（臨薬協）","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"行政指導","action_date":"2024-09-01","announcement_date":"2026-04-27","violation_summary":"治験の不具合報告対象の範囲の見直しや、国際整合、リファレンスカントリー化、GCP調査の国際共同治験、規制の国際整合、働き方改革とITシステムの活用に関する取組を進めている。","violation_summary_en":"Reviewing the scope of adverse event reporting in clinical trials, promoting international harmonization, establishing reference countries, conducting international joint GCP inspections, harmonizing regulations internationally, and advancing initiatives related to work style reform and the utilization of IT systems.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_13968.html","url":"https://regbase.jp/enforcement/yakkiho-lin-chuang-yao-li-xie-huilin-yao-xie-20240901"},{"id":"27c18343-7347-45ae-bfe8-cef50f29d1bf","company_name":"臨薬協、AMDD、EBC","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["勧告"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"勧告","action_date":null,"announcement_date":"2026-05-04","violation_summary":"体外診の分類見直しと規制の国際整合推進。","violation_summary_en":"The Ministry of Health, Labour and Welfare issued a recommendation to the Japan Association of In Vitro Diagnostics (臨薬協), the Association of Medical Device Manufacturers (AMDD), and EBC regarding the reclassification and international harmonization of regulations for in vitro diagnostics.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_65484.html","url":"https://regbase.jp/enforcement/yakkiho-lin-yao-xieamddebc-unknown"}],"meta":{"query":"臨薬協","corporate_number":null,"law":null,"authority":null,"action_type":null,"count":3,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":2,"reset_at":"2026-08-05T19:07:53.089Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":266,"reset_at":"2026-08-06T19:06:53.089Z"}}}