Staying Ahead of the Curve in an Increasingly Complex...
Transcript of Staying Ahead of the Curve in an Increasingly Complex...
Staying Ahead of the Curve in an Increasingly Complex Regulatory World as seen from Novo Nordisk A/S, a global pharmaceutical manufacturer
Søren Thuesen Pedersen, Novo Nordisk A/S
The External Requirement Process
Capture of new requirements
Pre-analysisCapture of
industry practice trends
Capture of regulator
expectations
AnalysisPlanning (of
implementation)Implementation &
Report
Influence
Formal HandoverTo Process
Organisation
25 Focus Groups Line of Business (Process Groups)
Process landscape
EudraLex Vol 4 EU - GMP
GMP Directive for MP(Directive 2017/1572, 15. Sept 2017)
Treaty of the EU and
European Community(2007/C 306/01)
Chapter 1-9ICH Q7
includes GDP for APIs(ICH Q9 principles added)
GMP for ExcipientsICH Q9, ICH Q10, SMF, Batch
certificate, API conf.
GDP for MP & API guidelines;Inspections: Compilation of
commutiy procedures
MP: Medicianl Product
red: medicinal product,
blue: API; brown: GDP
green: in consutat ion
Sec
onda
ry L
aw (‘
leve
l 1’)
Reg
ulat
ory
stat
utes
Community code Medicinal products for human use
(Directive 2001/83/EC)
Prim
ary
Law
Authorization: Art 40
GMP: Art 47
Saftey features: Art 54a(2)
GDP: Art 84
Art 168(4)(a)Art. 114
& 168(4c)
GDPAPI Excipients
Art 63(4) Inspections
Safety feature
Falsified Medicines Dir (Directive 2011/62/EC)
New EC gui (ex Annex 13; 24.11.15)
amending
Art. 95 &
152(4)(b)
Sec
onda
ry L
aw (‘
leve
l 2’)
Manufacturing of Med.Dev ISO13485, EC Mark (Directive 93/68/EEC),
‘Blue Guide’ ECnotice 2016/C 272/01
Medical Device Regulation (Regulation 2017/745, 05. April 2017)
(9) authorisation; (17) GMP; (21) IMP-GMP
Advanced Therapy MP(Regulation EC 1394/2007)
Art 5. GMP for ATMP
Specific APIs or therapies, specific conditions, supporting GMP processes, procedural gui, enablers
Part II
GMP Active Substances as starting material (incl. GDP)
Part I
GMP Medicinal Product(i.e. drug products)
Part III
GMP related
documents
Other Documents
Related to GMP(incl. e.g. Inspections, Certificat ion)
Stephan Rönninger, Amgen, 22.12.2017
Chapter 1-9
Regulation on safety features (Delegated regulation 2016/161, 02 Oct 15)
* Guidance exists; see ’Others’
(comp. of comm.procedures)
GMP for IMPs GMP for Active Substances (Regulation No 1252/2014)
Art 63(1) GMP IMP
Clinical Trials RegulationRegulation 536/2014
Pharmacovigilance(Regulation 520/2012)
amending
Art 93
also: Food law (Reg
EC No 178/2002) and
Cosmetics (Reg EC
No 1223/2009)
Authorisation of MP(Regulation 726/2004)
GMP Regulation for IMP(Delegated regulations 2017/1569, 23 May 17)
In vitro diagnostic MD reg
(Regulation 2017/746, 05. April 2017)
EC guidelines:GMP for IMPs
Annexes 1-13-17, 19, 21, 18 (ex ICH Q7), 20 (ex ICH Q9)
Existing gui
GMP for ATMPs (gui C(2017) 7694)
Part IV
GMP for ATMPs
documents
Example EU-GMPs: Legal System
New Requirements
• There are 48 pharmacopoeias
• 20 sets of GMP regulation
• EU-GMP; EudraLex
• 21CFR11
• ISO
• OECD
• EAEU
Regulator expectations
• Novo Nordisk 60 inspections/year and
• 90 internal audits
Industry Practice Trends
• 250 + External representation seats
What are Compliance Signals?
Into OneQualityManagement System
GMP Compliance Signals (2013-2019)
358
245
520469
424
522500
25
92 106 125
57 73 73
190
66 79 75
2013 2014 2015 2016 2017 2018 2019(Estimate)
Created Influenced Handed over
FDA Quality Metrics
Continuous Manufacturing
EU Medical Device Regulation
MRA EU - Japan (biologics)
EAEU
Chinese Pharmacopeia 2020
ICH Q12
EU Annex 1
Novo Nordisk Monographs
Brexit
Quality Focus Areas2018-2019
We will always advocate for harmonization of regulatory requirements
Monitor Active
• All external representation by Novo Nordisk is registered in TAR, the Trade Association Representation
• Create Synergy
• Training
External Representation
My Take Home messages:
• Gives a good overview and confidence !• Somewhat laborious. • Senior Mgt. buy-in is critical
Questions?