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QMS regulation in Japan - 医薬品医療機器総合機構
Revised law went into effect in 25th Nov. 2014. Change of QMS inspection authority (see topic 3) Scope of Certification Standards will be expanded (see topic 3) Manufacturer’s License and Accreditation to Registration (see topic 4) Revision of QMS Ordinance QMS inspection per product family (see topic 4) 2nd Chapter became harmonized to ISO13485 (see topic 5)
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339 - pmda.go.jp
www.pmda.go.jp医薬品・医療機器等安全性情報 No.339 −3− 2016年12月 1 ミルナシプラン塩酸塩，デュロキセチン塩酸塩 及びベンラファキシン塩酸塩製剤の自動車運転等
Report on the Deliberation Results - pmda.go.jp
www.pmda.go.jpReport on the Deliberation Results . December 3, 2014 . Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau . Ministry of Health, Labour and Welfare
Filgrastim, Lenograstim, Nartograstim, Pegfilgrastim
www.pmda.go.jpPharmaceuticals and Medical Devices Agency This English version is intended to be a reference material for the convenience of users. In the event of
Pharmaceuticals and Medical Devices Safety …
www.pmda.go.jpPharmaceuticals and Medical Devices Safety Information No. 347 - 3 - October 2017 Abbreviations ADR Adverse drug reaction Alb Albumin ALP Alkaline phosphatase
The Ministry of Health, Labour and Welfare …
www.pmda.go.jpThe Ministry of Health, Labour and Welfare Ministerial Notification No. 519 Pursuant to Paragraph 1, Article 41 of the Pharmaceutical AŠairs Law (Law No.
2018.3 No. 267 - pmda.go.jp
www.pmda.go.jp1 2018. 3. dsu no. 267 重 要 生薬 510 サンシシ 2 漢方製剤 520 茵蔯蒿湯 3 温清飲 4 黄連解毒湯 3 加味帰脾湯 4
PMDA HP
www.pmda.go.jp後発医薬品品質情報 no.9 4 独立行政法人医薬品医療機器総合機構（pmda）では、本誌情報やジェネリック医薬品品質情報検討会の
PMDAからの医薬品適正使用のお願い - pmda.go.jp
www.pmda.go.jp医薬品医療機器総合機構PMDA. からの医薬品適正使用のお願い http://www.pmda.go.jp/safety/info-services/drugs/0001.html
IMPURITIES GUIDELINE FOR RESIDUAL S Q3C(R5)
www.pmda.go.jpinternational conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ich harmonised tripartite guideline impurities: guideline for …
2.7.2 summary of clinical pharmacology Studies
www.pmda.go.jpCONFIDENTIAL RM2003/00379/00 2.7.2 Summary of Clinical Pharmacology 4 ABBREVIATIONS 3TC lamivudine (EPIVIRƒ) ABC abacavir (ZIAGENƒ)AE Adverse Event AUC0-t,ss Area under the drug concentration-time curve from 0 to time t at steady state AUC∞ Area under the plasma concentration versus time curve from time 0 and …
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