HIS/EMP | WHO norms and standards – promoting quality and innovation for health products WHO NORMS AND STANDARDS – PROMOTING Quality & innovation for health products Technologies Standards and Norms Team Essential Medicines and Health Products Department
50
Embed
WHO norms and standards · ZIKA VIRUS WHO | “Public Health Emergency of International Concern” (01.02.16) o Call for Zika virus research and development o Diagnostics, Vaccines,
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHO NORMS AND STANDARDS – PROMOTING Quality & innovation for health products
Technologies Standards and Norms Team
Essential Medicines and Health Products Department
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHO’S NORMATIVE WORK ON DIAGNOSTICS, MEDICINES AND VACCINES
Dr David Wood
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
IT'S THE CORE OF WHO'S CORE BUSINESS
The Constitution requires WHO “to develop, establish and promote international standards with respect to biological and pharmaceutical
products”.
This has been done for more than 60 years now
The norms and standards are established by Expert Committees
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHAT IS A WHO EXPERT COMMITTEE?
o Official Advisory Body to Director-General of WHO
o Established by World Health Assembly or Executive Board
– WHO Expert Committee on Specifications for Pharmaceutical PreparationsSecretary: Dr Sabine Kopp
– WHO Expert Group on International Non-proprietary Names
Secretary: Dr Raffaella Balocco
– WHO Expert Committee on Biological Standardization
Secretary: Dr David Wood
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
LINK WITH WHO GOVERNING BODIESWHO Expert Committee reports are presented to the Executive Board
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHO GLOBAL STANDARDS AND NORMS – ROBUST, DURABLE and RESPONSIVE TO PUBLIC
HEALTH NEEDS
Global written standards Global measurement standardsTools for product development,
licensing and lot release
INNsA single name for a
substance for use globally
Tools for appropriate regulation
of quality, safety and efficacy
sofosbuvirnow in Essential
Medicines List to
treat
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
REFERENCE REAGENTSWHO MEASUREMENT STANDARDS
Dr Micha Nübling
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
ZIKA VIRUS
WHO | “Public Health Emergency of International Concern” (01.02.16)
o Call for Zika virus research and development
o , Vaccines, TherapeuticsDiagnostics
Zika virus outbreak
o in parts of the Americas
o since end 2014
o 0.5 - 1.5 mio infected
o potential association withmicrocephaly in newborns
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
Diagnostics development and evaluation need reference materials
o design of Zika in vitro diagnostics (IVDs)
o calibration, validation
o comparison of different IVDs
WHO Teleconference (01.02.16)
o coordinate global harmonisation efforts for Zika IVDs
o availability of materials
o assignment of tasks to WHO Collaborating Centers
ZIKA VIRUS
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHO COLLABORATING CENTERSblood products, in vitro diagnostics
NIBSC, UKNIBSC, UK
FDA CBER, USFDA CBER, US
PEI, DEPEI, DE
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
ZIKA VIRUSInternational Reference Reagents in preparation
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHO MEASUREMENT STANDARDSfor blood products and IVDs
Ebola NAT standard
o Recombinant virus particles
• parts of the Ebola RNA packaged in HIV-1 structural proteins
• 2 different preparations: cover whole Ebola genome
• introduction of stop codons
• non-infectious
o Collaborative study
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
HARMONISATION OF EBOLA NATSby WHO International Reference Reagent
BEFORE AFTER
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
HARMONISATION OF ANTIEDV ASSAYS
Ebola Antibody standard
o Convalescent plasma from survivor
o Collaborative Study reactive in assays of different design
ELISAs
• Glycoprotein
• Nucleoprotein
• whole virus
Neutralisation assays
• Wt virus (BSL4)
• Pseudotype
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHO MEASUREMENT STANDARDSfor blood products and IVDs
ECBS 2015
o Ebola NAT and Antibody standards established as measurement standards
o In total 12 measurement standards established
o 16 new projects on measurement standards endorsed
WHO Measurement Standards
o worldwide recognized tools in biological standardization
o among WHO priority tasks in PHEICs (Zika, Ebola)
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
THE LAST MILE FOR VACCINE DELIVERY – A NEW
STANDARD TO VALIDATE STABILITY
Dr Ivana Knezevic
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHAT IS THE PROBLEM ?
o Almost all vaccines used in immunization programs today are
licensed for storage and distribution within a supply chain of
2°C to 8°C
Problem reported by IVB/ EPI:
� Extremely difficult in countries with limited cold chain and ice pack
� Increasing cost and/or logistical constraints of vaccine delivery
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHERE VACCINE STABILITY MIGHT BE AFFECTED?
VACCINE
STORAGE AT MANUFACTURER’S SITE
EXCURSIONS
RECONSTITUTION
STORAGE AT CLINIC
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHY DO WE NEED A NEW STANDARD?
o Many vaccines are stable beyond 2 – 8°C for some time but they cannot be used as such without a proper licensing
o Label changes to support decision making for use of a vaccine following exposure:
• to specific temperature
• for a short period of time
� New standard is needed to guide regulators and manufacturers to assure vaccine stability throughout the life cycle of the product including the last mile towards each child or adult
HIS/EMP | WHO norms and standards – promoting quality and
innovation for health products
WHEN AND HOW IS A NEW STANDARD DEVELOPED?
o 2010 – 2015: novel approaches for assessing stability of vaccines intended
for use in extended controlled temperature chain (ECTC) led to many
technical questions
o Consultation process with regulators, industry and other experts:
• different opinions and views - great enthusiasm or resistance
• from initial misunderstandings, consensus developed with stakeholders
on definitions, guiding principles, and technical requirements