USP Update

Anthony Tann, Jennifer DerryJune 20, 2019

Agenda

USP Priorities for South Korea

Chemical Medicines

Biologics

Dietary Supplements/Herbal Medicines

USP Convention 2020

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© 2018 USP

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© 2018 USP

USP – Building Trust for almost 200 years

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© 2018 USP

USP - Global reach to advance quality

Our standards are legally

recognized in over 50 countries

and 160+ utilize our standards

Our collective knowledge of people

around the world

Beyond lab operations

– Regulatory affairs

– Strategic customer development

– Public Health

Build team for stakeholder engagement

for government and industry driven

impact

Independent, not-for-profit organization, self

funded

Strengthening systems to ensure access to

quality medicines Technical assistance to regulatory agencies to perform critical

functions, including dossier evaluation and market

authorization, inspections, post-marketing surveillance, and

testing and quality control of medical products

Supporting manufacturers to increase the

supply of quality medicines End-to-end support for manufacturers to implement strong

quality systems, identify and address corrective actions, file

dossiers for product approval, and prepare for inspections.

USP helps protect patients and supports access to quality medicines

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*Based on current US exchange rate

Source: WHO, World Bank, Euromonitor, IQVIA Market Prognosis Q3 2018; IQVIA analysis

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Emerging Maturing Developed

Asia is a diverse mix of developed, maturing and emerging markets

Developed Markets

Innovation and thought leadership in

quality standards development for

new therapies

– Biotherapeutics

– Advanced therapies

Maturing and Emerging Markets

Capability building and education

– Pre-market development in

system maturing

– Strengthening in product quality

– Post market safety surveillance

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USP – Korea: A Rich History of Bilateral Cooperation since 2012

USP hosted the MFDS officers from Korea in Chemical Medicines, Food Fraud Database; short term Visiting Scientist Program, Herbal Medicines

Scientific collaboration begun with executive exchange resident resulted in two chemical medicine monograph donations from Korean companies and laid the groundwork for further collaboration

Emerging biopharma in Korea opens further opportunities for scientific collaboration with biologicals

– Two members from Korea (one from NIFDS and two from industry) were part of the Biologics Expert Members

Education programs to build regulatory capacity and train manufacturers

Identify standards are needed by both USP and Korea and jointly develop one to three standards

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USP will promote alignment with all stakeholders to develop

quality standards for biological medicines

– Standards to facilitate quality throughout the product

lifecycle, from development and manufacturing all the

way to the patient

– Continue to modernize standards for legacy biological

products

– Performance standards for peptides, therapeutic

proteins, cell and gene therapies etc.

Advancing impact on biologics through a combined

approach with focus on :

– Roundtables, workshops

– Expert panels and committees

– Education

– Collaborations and partnerships in studies / development

Collaboration with USP in safeguarding the quality of biological medicines

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© 2018 USP

Support biologics analytical testing throughout the product lifecycle

Used to ensure and demonstrate methods and process performance

Broadly targeted at product families or classes

USP approach to development of standards

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Strengthen relationship with NIFDS/MFDS

Memorandum of Understanding since 2012

– Standards Development Esomeprazole strontium

On-going: Gemifloxacin

– Collaborative Testing Laboratory

– Advocacy and Awareness Joint scientific symposium

– Training and Capacity Building Participate in expert committees and expert panels

Short and Long term scientific exchange programs

Future Activities

• Increased focus on support to industry – especially in biologics

• Increased collaboration between NIFDS, manufacturer’s associations and USP

USP Priorities for South Korea

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© 2018 USP

Strengthen relationship with other stakeholders

KOBIA and KPBMA

– Newly invited as observers to USP Convention

KDRA (Korean Drug Research Association) and KHSA (Korean Health Supplement

Association)

Industry Members

USP Priorities for South Korea

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© 2018 USP

Conduct 1-2 technical round table discussions with manufacturers to address where

USP can provide support in product development and testing processes

Meet with NIFDS Biologics reviewers once a year to hold technical discussions on

concerns and hurdles on biologics assessments and where USP can provide support

Biologics

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Establish NIFDS as a collaborative testing lab for USP

– Pilot with two countries: Russia and Korea

– ISO 17025 Accreditation requirement

Monograph and reference standard collaboration with industry

– Priority list on usp.org

1. https://www.usp.org/get-involved/partner/modernization-priority-new-monograph-lists

Chemical Medicines

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Conduct 1-2 stakeholder forums for knowledge sharing of work USP conducts in the

dietary supplement and herbal medicines space

Further collaborate with NIFDS and industry association to schedule trainings/courses

on various topics – for example: GMP requirements

Co-develop monographs for herbal medicines to be listed in HMC – Herbal Medicines

Compendium

Monograph and reference standard collaboration with industry

– Priority list on usp.org

– https://www.usp.org/get-involved/partner/modernization-priority-new-monograph-lists

Dietary Supplements/Herbal Medicines

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New Standards

– Contributions from industry may be in forms of monographs and general chapters

Revised Standards

– in order to stay current with changes in industry, you may submit current analytical

procedures and supporting validation data, or

– Submit small amounts of materials to assist in USP standards development

For further guidelines:

– https://www.usp.org/get-involved/donate/submission-guidelines

Collaboration with Industry

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Volunteers Make it Happen at USP

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Volunteers Make it Happen at USP

Examples of Expert Panels

<825> Radiopharmaceuticals

Compounding Chapter

Exchange of Compounded Drug

Preparation Information in Health

IT Systems

Use of Enzymes in the

Dissolution Testing of Gelatin

Capsules

Herbal Medicines Compendium -

East Asia

Olive Oil Authenticity and

Quality

Performance Test for Semisolid

Dosage Forms

Cannabis Insulin Bioassay General Chapter

Herbal Medicines Compendium -

South Asia

<381> Elastomeric Closure for

Injections

New Advancements in Product

Performance Testing

Food Adulteration HQ - Parenteral Nutrition Safety <771> Ophthalmic Preparations

Probiotics HQ - USP Drug Classification Elemental Impurities

Pronunciation Project Honey Expert Panel Glatiramer

HQ - Drug Allergy and Intolerance

Classification

HQ - Health Literacy <660> Containers-Glass Expert

Panel

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USP–NF Online: Changes to Title and Format

One subscription for 20 users

USP will discontinue printing the USP–NF in the current format. The USP 43–NF 38 edition will be the last printed edition available - Nov 2019

USP 43 Supplement online only – May2020

USP 44 will be online only – USP NF 2021

© 2017 USP

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© 2017 USP

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