{"image_url":"https://cdn-ak.f.st-hatena.com/images/fotolife/K/KleineSchwarzeKatze/20260630/20260630141449.png","blog_url":"https://kleineschwarzekatze.hatenablog.com/","published":"2026-07-01 10:54:16","html":"<iframe src=\"https://hatenablog-parts.com/embed?url=https%3A%2F%2Fkleineschwarzekatze.hatenablog.com%2Fentry%2F2026%2F07%2F01%2F105416\" title=\"2.4 EU/EMA\u306e\u6700\u7d42\u6c7a\u5b9a\u306f\u3044\u3064\u304b\uff1aCHMP opinion\u5f8c\u306e\u6d41\u308c(\u6c7a\u307e\u308a\u6b21\u7b2c\u66f4\u65b0\u4e88\u5b9a) - \u9ed1\u732b\u7684\u6c34\u6676\u7403~\u4ffa\u306e\u6c34\u6676\u7389\" class=\"embed-card embed-blogcard\" scrolling=\"no\" frameborder=\"0\" style=\"display: block; width: 100%; height: 190px; max-width: 500px; margin: 10px 0px;\"></iframe>","height":"190","width":"100%","provider_name":"Hatena Blog","version":"1.0","type":"rich","author_url":"https://blog.hatena.ne.jp/KleineSchwarzeKatze/","categories":[],"url":"https://kleineschwarzekatze.hatenablog.com/entry/2026/07/01/105416","author_name":"KleineSchwarzeKatze","blog_title":"\u9ed1\u732b\u7684\u6c34\u6676\u7403~\u4ffa\u306e\u6c34\u6676\u7389","title":"2.4 EU/EMA\u306e\u6700\u7d42\u6c7a\u5b9a\u306f\u3044\u3064\u304b\uff1aCHMP opinion\u5f8c\u306e\u6d41\u308c(\u6c7a\u307e\u308a\u6b21\u7b2c\u66f4\u65b0\u4e88\u5b9a)","provider_url":"https://hatena.blog","description":"CHMP opinion\u5f8c\u3001EC final decision\u3078 EU\u3067\u306f\u3001CHMP opinion \u304c\u51fa\u305f\u5f8c\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u304c\u6700\u7d42\u7684\u306a\u6cd5\u7684\u62d8\u675f\u529b\u306e\u3042\u308b\u6c7a\u5b9a\u3092\u51fa\u3059\u4e88\u5b9a\u3002EMA\u306e\u4e00\u822c\u8aac\u660e\u3067\u306f\u3001CHMP opinion \u3092\u53d7\u3051\u3066\u6b27\u5dde\u59d4\u54e1\u4f1a\u304c\u901a\u5e38 67\u65e5\u4ee5\u5185\u306b\u8ca9\u58f2\u627f\u8a8d\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u3092\u51fa\u3059\u6d41\u308c\u3067\u3042\u308b\u3002 \u305f\u3060\u3057\u3001Article 20 referral \u3067\u306f\u3001\u518d\u5be9\u67fb\u3001\u8ffd\u52a0\u30c7\u30fc\u30bf\u3001\u624b\u7d9a\u304d\u4e0a\u306e\u8abf\u6574\u306a\u3069\u3067\u5909\u52d5\u3057\u5f97\u308b\u3002EMA\u306eArticle 20 non-pharmacovigilance\u624b\u7d9a\u304d\u306eQ&A\u3067\u3082\u3001CHMP\u306f\u8ffd\u52a0\u30c7\u30fc\u30bf\u3001oral explanation\u3001\u5c02\u9580\u5bb6\u4f1a\u5408\u306a\u3069\u306e\u305f\u3081\u306b\u671f\u9650\u3092\u5ef6\u9577\u3057\u5f97\u308b\u3002 CHMP op\u2026"}