@pipeworx/jp-pmda-approvals

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Tools: 4

Japan’s approved new prescription drugs as the Pharmaceuticals and Medical Devices Agency (PMDA) publishes them: every new-drug and partial-change approval since fiscal year 2018 with brand, applicant, approval date, ingredient and indication, the agency’s English index of review reports, its notices revising drug precautions, and its lists of approved medical devices.

Tools

• jp_pmda_approvals_search(query?, year?, limit?) — searches the agency’s yearly lists of approved new drugs (fiscal years run April to March). Each row has brand name and presentations, applicant and corporate number, approval date, approval type (new product or partial change), review field, the Japanese ingredient name, the indication line and flags such as orphan drug. The lists are Japanese: search with katakana brands, Japanese ingredient names, companies or indication words. year is a fiscal year, recent (default, latest three) or all. Every answer states the fiscal years searched and the latest approval in them.
• jp_pmda_review_reports_search(query, limit?) — searches the agency’s English index of review reports by English brand name or non-proprietary name. Returns the month approved and the links to the English translation and the Japanese original. Only new-active-ingredient drugs the agency chose to translate are indexed.
• jp_pmda_safety_search(query?, date_from?, fiscal_year?, limit?) — searches the agency’s notices that revise the precautions for use of a drug (使用上の注意の改訂指示通知): notice date and number, the generic ingredients concerned (Japanese names), and links to the revision text and the investigation report. The wording of each change is in the linked documents, which are not read. Fiscal years 2018 onward; default the three most recent.
• jp_pmda_device_approvals_search(query?, year?, category?, limit?) — searches the agency’s yearly lists of approved medical devices in four lists (new, improved_clinical, improved_no_clinical, generic): brand, generic device-type name, applicant, approval date and type, approval number where listed, and for new and clinical-data improved devices the clinical field, purpose, clinical basis and review period. Default the two most recent fiscal years across all four lists; the list of remanufactured single-use devices is not read.

Auth

Keyless.

Data sources

• PMDA (医薬品医療機器総合機構), list of approved new drugs (新医薬品の承認品目一覧): read live per call, nothing stored. Fiscal years 2018 onward are readable; older years are published only as legacy spreadsheets or PDF and are reported as unread, never as empty. The current fiscal year is partial.
• PMDA, English index of review reports for new-active-ingredient drugs.
• PMDA, notices of revisions of precautions for drugs (使用上の注意の改訂指示通知): read live per call, one page per fiscal year. Fiscal years 2018 and 2019 carry the posting date rather than the issue date (the answer says which). A year whose page cannot be read is reported as unread.
• PMDA, lists of approved medical devices (新医療機器・改良医療機器・後発医療機器の承認品目一覧): read live per call, one spreadsheet per list per fiscal year, 2018 onward. A year the agency publishes only as a PDF is reported as unread, never as empty.

Traps worth knowing: the lists carry no English names (brand names are katakana, ingredients are Japanese names), so an English query on the list finds only Latin text; the review-report index is the English route. Neither source has a per-product record page, so there is no get-by-id tool. The package-insert and review-report document search on the agency’s site is a script-driven form and is not read. A zero-match answer says which fiscal years were searched; year=all widens it.

Tools

• jp_pmda_approvals_search — Search Japan’s approved new prescription drugs as the Pharmaceuticals and Medical Devices Agency (PMDA, 医薬品医療機器総合機構) lists them by fiscal year (April to March): every new-drug approval and partial-cha
• jp_pmda_review_reports_search — Search the PMDA’s English index of review reports for drugs approved in Japan with a new active ingredient: by English brand name or non-proprietary name (e.g. Keytruda, pembrolizumab). Each entry giv
• jp_pmda_safety_search — Search Japan’s notices that revise the precautions for use of a drug (使用上の注意の改訂指示通知) as the Pharmaceuticals and Medical Devices Agency (PMDA) lists them by fiscal year: for each notice the date, the n
• jp_pmda_device_approvals_search — Search medical devices approved in Japan as the Pharmaceuticals and Medical Devices Agency (PMDA) lists them by fiscal year (April to March) in four lists: new devices (新医療機器), improved devices with c