🛡️ Japan PMDA New Drug Approval Watch

Japanese new-drug approvals as PMDA records them: approval date, brand name, marketing-authorisation holder with its corporate number, active ingredient, approval kind (new approval vs partial change) and the approved indication. Read from PMDA's own fiscal-year approval workbook, so a delta means a drug was approved — not that a document was regenerated.

Output is one drug_approval_record row per result; billing is pay-per-event, the value event being one drug approval delta (a $0.02 start fee per run, then $0.20 per drug approval delta plus one $0.10 source check per run that reads the source). Source: www.pmda.go.jp.

📊 Sample Output

Real rows from run VyThPS4umQCQ7yj9j on build 0.1.13 (2026-09-17), the same input as the Quick start below — every value is as the source published it (emails masked, long text shortened):

approval_date	brand_name	holder	corporate_number	ingredient	indication
2026-05-11	ミムリット皮下注用	第一三共㈱	1010001095640	弱毒生麻しんウイルス（ＡＩＫ－Ｃ株）、弱毒生ムンプスウイルス（ＲＩＴ４３８５株）、弱毒生風しんウイルス（高橋株）	麻しん、おたふくかぜ及び風しんの予防を効能・効果とする新有効成分含有医薬品及び新医療用配合剤
2026-05-18	ゼップバウンド皮下注2.5 mgアテオス	日本イーライリリー㈱	3140001012176	チルゼパチド	肥満症 ただし、高血圧、脂質異常症又は耐糖能障害（2型糖尿病、耐糖能異常等）のいずれかを有し、食事療法・運動療法を行っても十分な効果が得られ
2026-05-18	ソーティクツ錠6 mg	ブリストル・マイヤーズスクイブ㈱	9011101044273	デュークラバシチニブ	既存治療で効果不十分な下記疾患 ○乾癬性関節炎 を効能・効果とする新効能医薬品
2026-05-18	ジャスケイド錠9 mg	日本ベーリンガーインゲルハイム㈱	1010701019774	ネランドミラスト	特発性肺線維症 進行性肺線維症 を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】
2026-05-18	ファセンラ皮下注30 ｍｇシリンジ	アストラゼネカ㈱	9120001073652	ベンラリズマブ（遺伝子組換え）	好酸球増多症候群を効能・効果とする新効能・新用量医薬品 【希少疾病用医薬品】
2026-05-18	エムネクスパイク筋注シリンジ12歳以上用	モデルナ・ジャパン㈱	4010401159678	SARS-CoV-2のスパイクタンパク質のN－末端部位及び受容体結合部位をコードするmRNA	SARS-CoV-2による感染症の予防を効能・効果とする新有効成分含有医薬品
2026-05-18	アレセンサカプセル150 mg	中外製薬㈱	5011501002900	アレクチニブ塩酸塩	ALK 融合遺伝子陽性の進行・再発の固形癌を効能・効果とする新効能・新用量医薬品
2026-05-18	アレックスビー筋注用	グラクソ・スミスクライン㈱	2011001026329	RSウイルスPreF3抗原	RSウイルスによる感染症の予防を効能・効果とする新用量医薬品

The run finished with the status message: NORMAL: emitted 10 item(s)

✅ What you get

Each row is flat JSON with these fields (from the dataset schema and the sample run; a field the source does not publish for a given row is null):

• record_key (string/null) — e.g. pmda:2026:2026-05-11:ミムリット皮下注用
• fiscal_year — e.g. 2026
• approval_date — e.g. 2026-05-11
• review_division — e.g. ワクチン
• sequence_no — e.g. 1
• brand_name — e.g. ミムリット皮下注用
• holder — e.g. 第一三共㈱
• corporate_number — e.g. 1010001095640
• approval_kind — e.g. 承 認
• ingredient — e.g. 弱毒生麻しんウイルス（ＡＩＫ－Ｃ株）、弱毒生ムンプスウイルス（ＲＩＴ４３８５株）、弱毒生風しんウイルス（高橋株）
• indication — e.g. 麻しん、おたふくかぜ及び風しんの予防を効能・効果とする新有効成分含有医薬品及び新医療用配合剤
• sheet — e.g. 承認品目5月分
• record_type (string) — e.g. drug_approval_record
• delta_type (string/null) — null in every sample row

Every run also writes a RUN_RECEIPT record to its key-value store with the source checks it made and the counts it charged — diagnostics never land in the paid dataset.

⚙️ Sample inputs

1. Quick start — the Store example (this is what the sample above came from)

{
  "fiscal_year": "2026",
  "brand_contains": [],
  "max_items": 10,
  "watch_mode": false,
  "baseline_id": "default"
}

The sample run charged exactly: 1 × $0.02 apify-actor-start + 1 × $0.10 source-check + 0 × $0.20 drug-approval-delta = $0.12 on the Free tier — snapshot preview rows are delivered unbilled; only the source check and the start fee were charged.

2. A smaller, narrowed run

{
  "fiscal_year": "2026",
  "brand_contains": [],
  "max_items": 5,
  "watch_mode": false,
  "baseline_id": "default"
}

Caps the run at 5 rows; same billing shape as the sample run above. fiscal_year narrows what the source is asked for.

3. Watch mode on a schedule

{
  "fiscal_year": "2026",
  "brand_contains": [],
  "max_items": 10,
  "watch_mode": true,
  "baseline_id": "default"
}

The first run seeds a private baseline and emits zero deltas; every later run emits one row per change, billed at $0.20 each plus the $0.10 source check; billed deltas are capped at 500 per run.

🧾 JSON sample record

One real record from run VyThPS4umQCQ7yj9j, exactly as it lands in the dataset (emails masked, long text shortened):

{
  "record_key": "pmda:2026:2026-05-11:ミムリット皮下注用",
  "fiscal_year": "2026",
  "approval_date": "2026-05-11",
  "review_division": "ワクチン",
  "sequence_no": "1",
  "brand_name": "ミムリット皮下注用",
  "holder": "第一三共㈱",
  "corporate_number": "1010001095640",
  "approval_kind": "承 認",
  "ingredient": "弱毒生麻しんウイルス（ＡＩＫ－Ｃ株）、弱毒生ムンプスウイルス（ＲＩＴ４３８５株）、弱毒生風しんウイルス（高橋株）",
  "indication": "麻しん、おたふくかぜ及び風しんの予防を効能・効果とする新有効成分含有医薬品及び新医療用配合剤",
  "sheet": "承認品目5月分",
  "record_type": "drug_approval_record",
  "schema_version": "1.0",
  "output_mode": "preview",
  "preview_cap": 25,
  "preview_truncated": 0
}

🔧 How it works

Transport. Plain HTTPS from the Apify platform, no proxy. Every request carries an identified contact User-Agent.

Charging. Each drug approval delta is charged at the moment it is pushed (drug-approval-delta); a row that fails to charge is not delivered, so the dataset count always equals the charged count. One source-check is charged per run that actually read the source.

Source

PMDA fiscal-year new-drug approval list, 承認品目一覧（新医薬品）(public, logged-out)

• https://www.pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0010.html

Public, logged-out only — no API key, login, cookie or CAPTCHA.

Snapshot mode is a PREVIEW

watch_mode: false returns at most 25 records, hard-capped in code regardless of any input, labeled output_mode: "preview". This actor sells change detection, not bulk record export.

Watch semantics

The first watch run stores a private baseline and emits zero deltas. Later runs emit NEW / CHANGED / REMOVED keyed on the source-native id with before / after and changed_fields. Billed deltas are capped at 500 per run; the overflow is reported as a named PARTIAL withholding, is never billed, and is re-detected on the next run.

Terminal states

NORMAL · SUCCEEDED-0: GENUINE_EMPTY · SUCCEEDED-0 (no change) · PARTIAL · BLOCKED. A zero with no evidence FAILS loud rather than exiting 0 quietly.

Approvals arrive in batches, not on a daily drip

PMDA approves new drugs in rounds and republishes its fiscal-year workbook in batches, so this feed is lumpy by construction. Measured on 2026-07-27: 38 approvals across a 39-day span in the FY2026 workbook, about 6.8 a week — but 0 in the trailing 30 days, newest approval dated 2026-06-19.

That is the source behaving normally, not this Actor failing. Expect long quiet stretches and then several deltas in a single run. Read a SUCCEEDED-0 (no change) as "the workbook has not been republished since the last read", not as "no drugs were approved" — and budget against the batch rather than against a daily average.

What is not done. No login, no cookie or CAPTCHA bypass, no private or personal-account data, no browser automation.

⏰ Set it on a schedule

A single run is a snapshot. The value is the feed: open the actor in Apify Console → Schedules → Create new, add this actor with input 3 above (watch_mode: true), and pick a cadence:

• Daily — 0 7 * * * (07:00 UTC): catch changes within a day.
• Weekly — 0 7 * * 1: a Monday digest.

The baseline persists in a named key-value store between runs, so every scheduled run compares against the last one; use a different baseline_id for independent watches. Schedules can also POST results to a webhook (Console → Integrations).

💰 Pricing example

Event	Free	Bronze	Silver	Gold
Actor Start (apify-actor-start)	$0.02	$0.02	$0.02	$0.02
Source check (source-check)	$0.10	$0.09	$0.08	$0.07
Drug Approval Delta (drug-approval-delta)	$0.20	$0.18	$0.16	$0.13

Worked at the live Free-tier price (watch mode, one delta per change):

• 8 drug approval deltas: $0.02 start + $0.10 source check + 8 × $0.20 = $1.72
• 25 drug approval deltas: $0.02 start + $0.10 source check + 25 × $0.20 = $5.12
• 400 drug approval deltas: $0.02 start + $0.10 source check + 400 × $0.20 = $80.12

A run that delivers zero rows charges the $0.02 start fee plus the $0.10 source check (the source was read and reported empty). A BLOCKED run (source refused) fails loud and charges no value event. The start fee is charged once per GB of run memory; the default run memory is 1024 MB.

Yield on the sample run: NORMAL: emitted 10 item(s). max_items is a hard ceiling on what is delivered and billed, never a target. Snapshot output is capped at 25 records regardless of the cap you set; watch mode is the full feed.

⚖️ Legal & ToS

This actor reads public, logged-out pages and feeds published by www.pmda.go.jp. It collects only what the source publishes to any visitor, identifies itself with a contact User-Agent, and does not access accounts, private data or anything behind authentication. Use the output in line with the source's terms and your local law; the intended use is B2B research and monitoring.

❓ FAQ

Q: Do I need an API key or a login?
A: No. The source (www.pmda.go.jp) is read logged-out; the input schema has no key field and the actor carries no secrets.

Q: Why did my run return 0 rows?
A: Read the run's status message. GENUINE_EMPTY means the source was read and had nothing in scope for your input (in watch mode the first run always seeds the baseline and returns zero deltas); BLOCKED means the source refused and the run failed without billing a value event — retry later or narrow the input. A zero-row run bills the start fee plus one source check.

Q: How many rows can one run return?
A: Up to max_items (default 400); snapshot previews stop at 25. Raise the cap for a bigger run; you pay per delivered row.

Q: What does watch mode remember between runs?
A: A private baseline of source-native record ids in a named key-value store (baseline_id names it, so several independent watches can coexist). Each later run diffs the live source against it and emits only changes.

Q: How fresh is the data?
A: Every run reads the source live at run time; nothing is cached between runs except the watch baseline. Put it on a schedule for a continuous feed.

Q: What formats can I export?
A: The dataset downloads as JSON, CSV, Excel, XML or RSS from the run's Dataset tab or the Apify API, and any run can push to a webhook or integration.

Q: How is this different from the other product safety and approvals watches actors?
A: Same output shape and billing model; this one covers www.pmda.go.jp. The siblings under Related Actors cover the other sources or slices — run several on one schedule for a combined feed.

🆘 Troubleshooting

• Run FAILED with BLOCKED → the source refused the request or changed its page shape → nothing was billed beyond the start fee; retry after a while, and if it persists open an Issue with the run id.
• Status says CAPPED → your cap (max_items) was reached → raise it for a bigger run.
• Input validation error on start → a field is outside the schema's allowed values → start from the Quick start block and change one field at a time.
• Run TIMED-OUT → a very wide request on a slow day → raise the run timeout in Run options or narrow the input; what was delivered before the timeout is still in the dataset.
• First watch run shows no deltas → expected: it seeds the baseline; changes appear from the second run.

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