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
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