BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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www.biopharminternational.com September 2019 BioPharm International eBook 45 Resources EUROPE The following are some notable guide- lines and resources from the European Medicines Agency (EMA)*: EMA Website • Pharmacovigilance Information • Guideline Search • Biosimilar Market Authorization • R e s e a r c h a n d D e v e l o p m e n t Information • M a r k e t i n g A u t h o r i z a t i o n Information • Post-Authorization Information EMA Key and New Guidelines • Guideline on the Environmental R isk A s s e s sment of Med ic i na l Products for Human Use • Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells • Guideline on Similar Biologica l Med icina l Products Conta ining Recombinant Granulocyte-Colony Stimulating Factor (Rg-CSF) • Questions and Answers on Bovine S p o n g i fo r m E n c e p h a l o p a t h i e s (BSE) and Vaccines • Gu ide l i ne on Q u a l it y A s p e c t s I n c l u d e d i n t h e P r o d u c t I n f o r m a t i o n f o r Va c c i n e s f o r Human Use • R e f l e c t i o n P a p e r o n t h e Qua lif ication of Non-Genotoxic Impurities • Guideline on the Quality of Water for Pharmaceutical Use • Concept Paper on the Revision of the Guideline on the Evaluation of Anticancer Medicinal Products in Man • G u i d e l i n e o n t h e R e p o r t i n g o f P h y s i o l o g i c a l l y B a s e d P h a r m a c o k i n e t i c ( P B P K ) Modelling and Simulation • Gu idel ine on Ac t ive Substa nce Master File Procedure Final • G u i d e l i n e o n G o o d Pharmacovigilance Practices (GVP) Product- or Popu lation-Specif ic C on s i d e r a t ion s I V: Pa e d i a t r ic Population • Ref lection Paper on the Use of Extrapolation in the Development of Medicines for Paediatrics WORLDWIDE T h e f o l l o w i n g a r e s o m e n o t a - b l e r e s o u r c e s f r o m t h e Wo r l d H e a l t h O r g a n i z a t i o n ( W H O ) and the International Council for Harmonization (ICH)*: WHO WHO Resources • WHO Regulation Information • WHO Biologics Information • WHO Drug Safety ICH Resources • ICH Guidelines • ICH Ref lection Papers • ICH Training ICH Guidelines • Q1A(R2) Stability Testing Of New Drug Substances And Products • V a l i d a t i o n O f A n a l y t i c a l Procedures: Text And Methodology Q2(R1) • Impurities In New Drug Substances Q3A(R2) • Impurities In New Drug Products Q3B(R2) • Impurities: Guideline For Residual Solvents Q3C(R7) • Guideline For Elemental Impurities Q3D(R1) • V i r a l S a f e t y E v a l u a t i o n O f Biotechnolog y Products Derived From Cel l Lines Of Human Or Animal Origin Q5A(R1) • Q u a l i t y O f B i o t e c h n o l o g i c a l P r o d u c t s : A n a l y s i s O f T h e Expression Construct In Cells Used For Production Of R-DNA Derived Protein Products Q5B • Q u a l i t y O f B i o t e c h n o l o g i c a l Produc t s: St abi l it y Te st i ng O f B i o t e c h n o l o g i c a l / B i o l o g i c a l Products Q5C • Derivation And Characterisation O f C e l l S u b s t r a t e s U s e d Fo r Production Of Biotechnological / Biological Products Q5D • C o m p a r a b i l i t y O f B i o t e c h n o l o g i c a l / B i o l o g i c a l Products Subject To Changes In Their Manufacturing Process Q5E • Spec i f icat ions: Test Procedu res And Acceptance Criteria For New Drug Substances And New Drug Produc ts: Chem ica l Substa nces Q6A • Spec i f icat ions: Test Procedu res A n d A c c e p t a n c e Cr it e r i a Fo r B i o t e c h n o l o g i c a l / B i o l o g i c a l Products Q6B • Q 7 G o o d M a n u f a c t u r i n g P r a c t ic e G u i d a n c e fo r A c t i v e P h a r m a c e u t i c a l I n g r e d i e n t s Questions and Answers Guidance for Industry • P h a r m a c e u t i c a l D e v e l o p m e n t Q8(R2) • Quality Risk Management Q9 • Pha r maceut ica l Qua l it y Sy stem Q10 • Q 1 1 D e v e l o p m e n t a n d Manufacture of Drug Substances-- Questions and Answers (Chemical Ent it ie s a nd Biotec h nolog ic a l / Biological Entities) • Te c h n i c a l A n d R e g u l a t o r y Considerations For Pharmaceutical Produc t Li fec yc le Ma nagement Q12 *Information and links current as of September 15, 2019. PATHEON ...........................................................35 THERMO FISHER .................................................5 USP ................................................................. 17 WUXI BIOLOGICS US ....................................... 2 Ad Index COMPANY PAGE

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