監視指導・麻薬対策課（Compliance and Narcotics

監視指導・麻薬対策課（Compliance and Narcotics Division）
１．医薬品・医薬部外品ＧＭＰ省令の要求事項への適合状況に関する事項（医薬品製剤証明書に関する事項を除く。）
２．機器・体外診ＱＭＳ省令の要求事項への適合状況に関する事項
３．再生医療等製品ＧＣＴＰ省令の要求事項への適合状況に関する事項
４．治験薬ＧＭＰ通知の要求事項への適合状況に関する事項

ผลลัพธ์ (อังกฤษ) 1:

Monitoring guidance and Narcotics Division (Compliance and Narcotics Division)1. Matters concerning the compliance to the requirements of pharmaceutical and medicinal products GMP Ordinance (except on the pharmaceutical preparation certificate matters. ）2. Devices and in-vitro diagnostic considerations regarding the conformity to the requirements of the QMS Ordinance3. Matters concerning the situation of regenerative medicine products GCTP Ordinance requirements4. Matters concerning the conformity to the requirements of the investigational drug GMP notification

ผลลัพธ์ (อังกฤษ) 2:

Monitoring guidance and counter-narcotics Division (Compliance and Narcotics
Division) 1. (Excluding the matters related to pharmaceutical formulations certificate.) Matters relating to compliance to the drugs and quasi-drugs GMP Ordinance requirements
2. Matters concerning compliance to the equipment and in vitro examination QMS Ordinance requirements
3. Matters concerning compliance to regenerative medicine, product GCTP Ordinance requirements
4. Matters concerning compliance to the investigational drug GMP notification requirements

ผลลัพธ์ (อังกฤษ) 3:

Monitoring and guidance measures and matters related to Narcotics Division of Compliance Ordinance (including software and Narcotics Division drugs, quasi-drugs GMP conformance requirements (excluding the matters concerning the certification (pharmaceutical) 2 of 3 items of equipment to the Ordinance and in vitro diagnosis QMS conform to the situation at the particular requirements for products of the Ordinance to regenerative medicine GCTP conform to the requirements of the particular situation of drug GMP notice to conform to the requirements of the situation