This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are propos...
EMA’s new draft guideline entitled “Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container” from April 2016 contains clear provisions with regard to the acceptance of alternative sterilisation processes by the European authorisation authorities. Those...
treatment during growth with pesticides etc., and drying and storage conditions should be included. It should be confirmed that an adequate quality assurance system for the collection and/or cultivation, harvest and primary processing according to the ‘Guideline on good agricultural ...
ema制剂成品生产指南-2017(中英文)完整版.doc,EMA 制剂成品生产指南-2017 4 JJuly 2017 EMA/CHMP/QWP/245074/2015 Committee for Human Medicinal Products (CHMP) Guideline on manufacture of the finished dosage form 制剂成品生产指南 This guideline replaces the “N
This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are propos...
This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are propos...
FinishedDosageForm”8 (CPMP/QWP/486/95)9 Commentsshouldbeprovidedusingthistemplate.Thecompletedcommentsformshouldbesent toQWP@ema.europa.eu 10 KeywordsManufacture,drugproduct Guidelineonmanufactureofthefinisheddosageform EMA/CHMP/QWP/245074/2015Page2/13 Guidelineonmanufactureofthefinisheddosageform11 Table...
Commentsshouldbeprovidedusingthistemplate.Thecompletedcommentsformshouldbesentto EWPSecretariat@ema.europa.eu 11 KeywordsInteraction,guideline,metabolism,inhibition,induction,transport,absorption, food,distribution,herbal,SmPC,SPC 12 2/38 GuidelineontheInvestigationofDrugInteractions13 14 15 16 17 18 19 20 ...
CommentsshouldbeprovidedusingthisEUSurveyform.Foranytechnicalissues,pleasecontact theEUSurveySupport. 11 KeywordsGuideline,syntheticpeptide,solidphasesynthesis,liquidphasesynthesis, fragmentcondensation,comparability,aminoacids,solidsupportresin, linker,conjugation,deprotection,coupling,capping,cleavage,pooling ...
EMA工艺验证指南EMACHMPCVMPQWPBWP702782012Rev1 27 February 2014Committee for Medicinal Products for Human Use CHMPCommittee for