Transcript Slide 1

6th Annual Science and Standards Symposium
January 16, 2013
Istanbul
USP Compendial Updates
Angela G. Long, M.S.
Senior Vice President, Global Alliances and Organizational
Affairs/Executive Secretariat
Topics
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USP Mission and Overview
 USP Council of Experts
 USP’s Core Compendia and Reference Materials
 Compendial Updates
 USP in the World
 How to Get Involved with USP
USP’s Mission
To improve the health of people
around the world through public standards
and related programs that help ensure
the quality, safety, and benefit of
medicines and foods.
USP – An Overview
 Since
1820, nonprofit, private, independent, and selffunded
 Headquartered
in Rockville, Maryland; 700+ employees;
facilities in India, China, Switzerland, Brazil, and Ethiopia
 Expert
volunteers are scientific decision-makers
 Internationally recognized and globally focused
USP’s Statements on Standards
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Modern public standards should exist for all medicines
and foods
 Public standards play a key role in ensuring quality,
safety and benefit by allowing independent testing
 USP standards are science-based and data-driven
 USP is not involved in market access or regulatory
approval decisions
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USP RS may have multiple compendial uses, and are
made available to the public without restriction
USP works in many ways to promote harmonization
USP partners with pharmacopeias and regulatory
authorities throughout the world to support their work
and increase availability of public standards
USP and NF are Official Compendia
USP is cited in law…
 1848: Drug Import Act
 1906:
1906 Pure Food and Drugs Act
 1938:
Food, Drug and Cosmetic Act
– Definition of a drug
– Adulteration
– Misbranding
– Drug product name
 1994:
 2003:
Dietary Supplement Health Education Act
Medicare Modernization Act
(Model Guidelines for Medicare Formularies)
2010–2015 USP Council of Experts
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2010-2015 Council of Experts - Demographics
• 861 expert volunteers serving on 24 Expert Committees and
65 Expert Panels
• 366 Expert Committee members
* This number does not include Expert
• 372 Expert Panel members*
Committee members also serving on
• 123 Government Liaisons
Expert Panels.
– 111 FDA Liaisons
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CDER: 76
CFSAN: 13
CBER: 12
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CVM: 6
ORA: 3
CDRH: 1
3 Chinese Pharmacopoeial Commission Representatives
1 European Food Safety Authority Representative
2 Health Canada Representatives
1 Indian Pharmacopoeial Commission Representative
1 NIST Representative
3 Brazil (ANVISA, Brazilian Pharmacopoeia, INCQS)
1 CCAYAC/COFEPRIS (Mexico)
2010-2015 Council of Experts - Demographics
• 738 Expert Committee and Expert Panel members
– 216 (29%) international experts from 34 countries:
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Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
Costa Rica
Denmark
France
Germany
India
Israel
Italy
Japan
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Jordan
Mexico
Netherlands
Peru
Portugal
South Africa
Saudi Arabia
Scotland
South Korea
Spain
Sweden
Switzerland
Taiwan
Ukraine
United Kingdom
Uruguay
Venezuela
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Core USP Compendia
1.
The United States Pharmacopeia
2.
National Formulary (USP–NF)
3.
Food Chemicals Codex (FCC)
4.
USP Dietary Supplements
Compendium (DSC)
5.
USP Medicines Compendium (MC)
6.
USP on Compounding
7.
Coming soon: Herbal Medicines
Compendium (HMC)
 Other
Resources
– Pharmacopeial Forum (PF)
– FCC Forum (FCCF)
– USP Dictionary
– Chromatographic Columns
USP Reference Standards
 Trusted
for pharmaceutical quality control worldwide
 Over 2,900 Reference Standards now available
 Support FDA-enforceable standards and tests in
the USP–NF
 Highly pure, with purity values provided for quantitative standards
 Stocked and ready to ship same day
(2-day delivery within U.S.)
USP–NF Translations
Spanish Translation
Russian Translation
In the works…Chinese Translation
USP Medicines Compendium: www.usp-mc.org
Unique Aspects of the Medicines Compendium
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Web-based, online only; open access to documentary
standards, including general chapters
Performance Based Monographs with USP-developed
Reference Procedures
Use of Certified Reference Materials for assays; Reference
Standards for Impurities
Public availability of the validation data
Monographs for some medicines that have never before had
public monographs
MC Expert Committees meet in USP global regions
MC Expert Committee adopts USP-NF general chapters
including some general chapters that are planned or proposed
in USP-NF but not yet official, e.g., <232> and <233> for
elemental impurities
Simplified, easy to access
Compendial Updates
 Elemental Impurities (General Chapters <232> and <233>)
postponement
 Other USP Key Issues
 Proposed Changes to General Notices
 USP Response to the Compounding Crisis in the US—
methylprednisolone acetate
 Monograph Naming Policy
 Publications Enhancements
• Searchable Errata
• Future: Publications 2.0
Elemental Impurities Postponement
http://www.usp.org/usp-nf/official-text/revision-bulletins/elemental-impuritieslimits-and-elemental-impurities-procedures
Watch for Updates on the Key Issues Page
http://www.usp.org/usp-nf/key-issues/elemental-impurities
USP’s Key Issues
http://www.usp.org/usp-nf/key-issues
Proposed Revisions to General Notices
http://www.usp.org/usp-nf/notices/proposed-revisions-general-notices-andrequirements-published-comment-pharmacopeial-forum-391-jan-feb-2013
USP’s Response to the Compounding Crisis
http://www.usp.org/usp-healthcare-professionals/compounding
Monograph Naming Policy, May 1, 2013
http://www.usp.org/usp-nf/development-process/compendialnomenclature/monograph-naming-policy
Monograph Naming Policy, Official May 2013
 Drug product monograph titles will include only the
active moiety
 Strength also will be expressed in terms of the
active moiety
 The names and strengths of both the active moiety
and specific salt form (where applicable) are
provided elsewhere on the label
 Included in General Chapter <1121> Nomenclature
Finalized 2007; Official May 1, 2013
Improvement: Searchable Errata
http://www.usp.org/usp-nf/official-text/errata
Pubs 1.0 Delivery
U
S
P
1. Multiple delivery platforms, but optimized for print.
2. Forum is independent. Feedback through private email
to liaison.
3. All customers and staff see the same thing.
Pubs 2.0 Delivery
USP Food Chemicals
Codex
U
S
P
xm
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1. Delivery optimized for each of multiple platforms.
2. Forum is integrated. Feedback can be private or public.
3. Different customers may see different content,
dependent on subscriptions or personalization.
PF Publications
 Currently
– A PF issue is published every 60 days and has a 90-day public review and
comment period
– Current publication schedule results in overlapping comment periods (i.e., the first
30 days and last 30 days overlap with other issues of PF)
– For USP staff, there are overlapping deadlines with no room for adjustments
 Proposed
Change
– Change from six to four PF issues per year, each with its own 90-day comment
period: Feb, May, Aug and Nov
– Implement in 2014 at the earliest
 Benefits
– Eliminates overlap allowing each PF to have its own uninterrupted comment period
– Eases internal processes
Official USP-NF Publications
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Current
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USP-NF Book and two Supplements are published each year based on six PF issues
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Takes 16 to 18 months for a PF proposal to reach the official date of the original target publication
(assuming no deferral)
Proposed Change
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Online USP-NF becomes the primary publication and consider options for print publication(s)
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Change from six to four PF issues each year and ballot Expert Committees after each PF
therefore four official updates per year
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Incorporate Accelerated Revisions into the four official publication
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Implement in 2014 at the earliest (change to PF schedule); details are evolving regarding the
changes to the official publication schedule
Benefits
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Shorten time from initial PF proposal to official date estimate is about 13 months, assuming no
deferral
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Will eliminate looking for new official text in multiple places; needs of print customers to be
considered
USP World Regions
USP Global Sites
New USP-India Site
Inauguration September 2, 2011
China Expansion—Fall 2013
Building Today
Architect’s Rendering
Opportunities to Get Involved with USP
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Comment on proposed revisions through the online
Pharmacopeial Forum
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Participate in Expert Committees, Expert Panels
– Calls for Candidates for Expert Panels ongoing
– Call for Candidates for the 2015-2020 Council of Experts coming
Fall 2013
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USP-sponsored Regional Laboratory Networks
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Visiting Scientist Program
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Global Fellowship Award Program
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International Training Program
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Science Meetings
Visiting Scientist Program
Promotes the scientific exchange
Hosts scientists from other countries at USP
to strengthen the alignment of the
participants’ technical competence and
experience with USP’s technical needs and
objectives.
The program typically a three-month visit to
USP’s headquarters in Rockville, Maryland
or to one of USP’s international sites, where
participants work hand-in-hand with USP
scientific and technical staff on projects of
mutual interest.
Participants are selected via a competitive
nomination process.
For more information, please
contact Nilsa Esters at:
[email protected]
Global Fellowship Awards Program
Provides support to students whose research directly addresses specific USP
scientific or research needs.
Awards three $50,000 Fellowships to students who have been accepted for fulltime study in a Ph.D. or Pharm.D. program or medical or dental school, or have
been awarded a postdoctoral research (non-faculty) appointment.
The program allows for subsequent yearly- funding for up to three years.
USP Research Fellows are selected through a review process to ensure the
alignment of the proposed research with specific areas of USP research needs.
Fellows work closely with USP scientific and technical staff throughout the
academic year and present their research results to USP standards-setting bodies.
For more information, please
contact Helen Kharab at:
[email protected]
International Training Program
Promotes the exchange of
scientific expertise between global
organizations committed to the
quality of medicines and foods.
Strengthens, expands, and
enhances existing compendial and
regulatory knowledge base.
Participants receive training with
USP scientific and technical staff on
compendial topics. Curriculum
includes classroom study
supplemented by laboratory
learning.
International Training Program
Two-week program at USP headquarters in the United States.
Priority is given to USP global collaborators established through
agreements and activities as part of USP’s strategic efforts in regions
and countries. Participation is open to national and regional OMCL’s,
pharmacopoeias, and other government agencies.
For more information, please contact Linda Stelling at [email protected].