About OMICS Group - PowerPoint Presentation

Slide1

About OMICS Group

OMICS Group International is an amalgamation of 

Open Access publications

 and worldwide international science conferences and events. Established in the year 2007 with the sole aim of making the information on Sciences and technology ‘Open Access’, OMICS Group publishes 400 online open access 

scholarly journals

 in all aspects of Science, Engineering, Management and Technology journals. OMICS Group has been instrumental in taking the knowledge on Science & technology to the doorsteps of ordinary men and women. Research Scholars, Students, Libraries, Educational Institutions, Research centers and the industry are main stakeholders that benefitted greatly from this knowledge dissemination. OMICS Group also organizes 300 

International conferences

 annually across the globe, where knowledge transfer takes place through debates, round table discussions, poster presentations, workshops, symposia and exhibitions

.Slide2

About OMICS Group Conferences

OMICS Group International is a pioneer and leading science event organizer, which publishes around 400 open access journals and conducts over 300 Medical, Clinical, Engineering, Life Sciences,

Phrama

 scientific conferences all over the globe annually with the support of more than 1000 scientific associations and 30,000 editorial board members and 3.5 million followers to its credit.

OMICS Group has organized 500 conferences, workshops and national symposiums across the major cities including San Francisco, Las Vegas, San Antonio, Omaha, Orlando, Raleigh, Santa Clara, Chicago, Philadelphia, Baltimore, United Kingdom, Valencia, Dubai, Beijing, Hyderabad,

Bengaluru

and Mumbai.Slide3

3Translating

Pharmacognosy

Knowledge into Healthcare: Research on Quality and Standards

10:55-11:15

Title: Current research on standards of medicinal plant products: Decoction pieces, granules and proprietary products as

phytomedicines

Kelvin Chan,

The University of Sydney & Western Sydney, Australia

11:15-11:35

Title: Notorious

Aristolochic

acids in traditional herbal medicines: Successful identification and validation using DNA barcodes, Real-Time PCR with

TaqMan

technology and UHPLC-HR-MS

Wei Sun,

China Academy of Chinese Medical Sciences, China

11:35-11:55

Title: Progress of R&D of Chinese

materia

medica

to keep up with advances in technology

De-an

Guo

,

Chinese Academy of Sciences, China

11:55-12:15

Title: Authentication and quality control of TCM herbs and herbal preparations

Yuan-

Shiun

Chang,

China Medical University, Taiwan

 Slide4

4

Current research on standards of medicinal plant products: decoction pieces, granules and proprietary products as

phyto

-medicines

Kelvin Chan

Joint Chair Professor in TCM

Faculty of Pharmacy, USyd

The National Institute of Complementary Medicine, UWSSlide5

5Topics to be touched on

The current public views on herbal products

Pharmacopoeia standards of Chinese materia medica: Role of methodology development

The current global regulations for Chinese herbal products as

phyto

-medicines

The future actionsSlide6

Frequently Asked Questions/Concerns about Herbal Medicinal Material and Proprietary Herbal Medicinal Products

What are the active ingredients prescribed

herbal medicines?

Do

herbal

products have to pass through the same strict

legislative procedures

as pharmaceuticals?

What is known about the quality, safety and efficacy of the

herbal products

?

What are the latest research directions towards QC/QA of herbal drugs?Slide7

7

WHO Report on Traditional MedicineSlide8

8

Differences between Orthodox Drugs and

Chinese Medicinal

Materials

(CMM)

**

refer to chemically defined established drugs. ** refer to either single herb or combination of several herbs in one prescription.

From:

Chan & Cheung,

Interactions

between Chinese Herbal Medicinal Products and Orthodox Drugs

, Taylor & Francis Group, September 11, 2000 by CRC PressSlide9

9

Process in quality assurance of herbal medicines

Typical procedure for quality standardisation of herbal medicines Slide10

Total Quality Management of

Chinese

Medicines

Industry

*GACP is now adopted as Good Agricultural & Collection Practice

*Slide11

Strategies for Achieving Quality Medicinal Herbal Products

Establishment of

Good

Agricultural & Collection Practice

for

of medicinal plants

Good Sourcing Practice for supply of materials

Good Laboratory Practice for chemical/biological analyses

Establishing reliable pattern recognition procedures for fingerprinting relationship of source materials

GMP of ready-made products with approved fingerprinting

GCTP of ready-made products Slide12
Slide13

Min County, Gansu: Transferring Danggui Young Seedlings in Green House to Open Fields

甘肃岷县：将当归幼苗转至绿色大棚以开辟土地Slide14

Danggui’s GAP Test Farms

当归良好农业规范试验田

Min County, Gansu Province

甘肃省岷县Slide15
Slide16
Slide17

GAP production bases of TCM herbs adopted by national certification before 2010 in China

Zhang

et al (2010), GAP Production of TCM herbs in China.

Planta

Medica

, 76: 1948-1955

GAP refers to: Good Agricultural PracticeSlide18

Some

Current G

AP Bases

of Chinese Materia Medica in China

[Zhang et al (2010), GAP Production of TCM

h

erbs in China.

Planta

Medica

, 76: 1948-1955

]

Site

of bases Cultivated medicinal Plants

Anhui province

Paeonia

suffruticosa

Chongqing

Pinellia

ternata

Gansu province

Angelica

sinensis

Guangxi

province

Momordica

grosvenorii

GuiZhou

province

Dendrobium

candidum

;

Eucommia

ulmoides

;

Hebei

province

Angelica

dahurica

;

Scutellaria

baicalensis

Heilongjiang

province

Panax

ginseng

Henan province

Panax

ginseng

Hubei province

Kehmannia

gluiinosa

Hunan province

Lespedeza

cyrtobotrya

Inner Mongolia

Eucommia

umloides

Jiangsu province

Glycyrrhiza

uralensis

Jilin province

Chrysanthemum

morifolium

Liaoning

province

Panax

ginseng;

Panax

quinquefolium

Ningxia

province

Panax

ginseng

Shandong

province

Lycium

chinensis

Shanghai

Lonicera

japonica

Shanxi province

Crocus

sativus

Sichuan

province

Salvia

miltiorrhiza

Tibet province

Crocus

sativus

;

Ligusticum

chuanxiong

Yunnan

province

Rhodiola

roseaDracaena

draco

;

Panax

notoginsengSlide19

Role of European Directorate for Quality Medicines & Healthcare (

EDQM)

Slide20

20

The EP Commission in Strasbourg 2005

*

‘Monographs on Herbal Drugs used in

Traditional Chinese Medicine should be developed

to give

a modern quality standard according to

European Pharmacopoeia principles and

to facilitate and encourage use

by practitioners for safe,

authorised products’

*

Slide from Prof Franz-©2009 EDQM, Council of Europe, All rights reservedSlide21

21

Commission of European Pharmacopoeia

(2008):

Set up Working Party of TCM at Strasbourg, EDQM

Président/Chairman Prof. Dr. Gerhard Franz

Other Experts:

A Prof. Dr. Rudolf BAUER

A Dr. Erich Andreas STOEGER

B Dr. Pierre DUEZ

CH Dr. Albert BLARER

CH Dr. Thomas LEHMANN

CH Dr. Eike REICH

D Dr. Uwe Michael GASSER

D Dr. Bernhard Klier

E Ms. Gloria GARCIA LORENTE

F Prof. Isabelle FOURASTE

F Mr. Robert SOUSSAIN

UK Prof. Dr. Kelvin CHAN --

AU Observer (since Mar 2010)

I Prof. Francesco VINCIERI

NL Dr. Mei WANG

TR Prof. Kemal Husnü Can BASERSlide22

Multi-disciplinary methods for the quality standardisation of CMM

Pharmacognosy: GAP and sample preparation

Capillary Electrophoresis

Carbohydrate analysis

Chemometrics

Authentication:

TLC

DNA

finger printing

UPLC/

HPLC

LC-MS

Biological

Clinical

Studies

Slide23

Strategic priorities

Optimisation

of manufacturing and analysis methods to achieve herbal product standardisation and predictable

bioactivity.

Contribute

to R&D product development methodologies in

TCM.

Progress

TCM bioinformatics / data

management.

Assisting

the development of Chinese herb cultivation in Australia (encompassing Good Supply Practice/Good Agriculture Practice

issues).

Developing

the national and international profile of NSW and Australia in

TCM.

Further

development of strategic TCM research priorities (to articulate with NICM TCM priorities

).Slide24

Salvia Miltiorrhiza Radix & Rhizoma (

Danshen

)

Panax

N

otoginseng

Radix &

Rhizoma

(

Sanqi

)

Angelica

S

inensis

Radix (

Danggui

)

Pueraria

Lobata Radix (Gegen

)Zingiber officinale

Rhizoma

(Ginger)

Granule

comparison with raw

materials

StandardisationSlide25

AnalysisUsing TLC and UPLC, quantifying several reference compounds.

Antioxidant activity

Chemometrics

GranulesSlide26

General results between decoction pieces & granules

CMM decoction pieces were in their own group.

CMM decoction pieces had consistent yields.

Antioxidant activity favoured CMM decoction pieces .

Quantification of more markers allowed greater comparison of products.

Did industry follow traditional decoction?

Pharmacopoeia needs

to define standards for

herbal granulesSlide27

27

Difference in registration of herbal products

China: TCMs treated and registered as a medicine, health-supplement

Europe: Traditional Herbal Medicinal Product

Registration Scheme is good for European traditional remedies (NB 30/15 year rule) but is a barrier to entry for TCMs and other non-EU traditional remedies

USA: stringent rules, need to claim efficacy for disease

Canada: ease of access via Natural Health Products route

Australia: risk strategy approach (different levels)Slide28

Dantonic

®

[

Danshen

Diwan

:

Radix

Salviae

miltiorrhizae

,

Radix

notoginseng

and

Borneolum

Syntheticum

] developed as a formulation for

treating chronic stable angina pectoris

in early 1990sApproved as a Class 4 drug by the SFDA in 1993CMC information (formulation development, specification, manufacturing process, stability test, etc)pre-clinical data (pharmacological studies and acute and sub-acute toxicity studies

clinical evidence (157 patients, positive control studies, Fu Fang Danshen Pian).

Used by more than 25 million people in chronic, 3-5 month administration, with substantial benefits and bioactivity superior to existing pharmaceuticals in one or more aspects in terms of safety, efficacy and cost-effectiveness

In 1996,

Dantonic

®

entered the first foreign market – Vietnam

The currently active IND (70,359) from the FDA received in June 2006 for the treatment and management of chronic stable angina

Phase II, randomized, placebo controlled studies in the USA and Australia conducted 2008-2009

In July 2010, the EOPII meeting with the US FDA was held, and the phase III studies are under active planning in the USA, EU, Australia and Asia

Case study:

Dantonic

®

Worldwide Markets (1

)Slide29

Country/Region

Legal status

Approval time

USA

Dietary supplement

Sep 2000

The United Arab Emirates

Prescription drug

Jun 2001

South Korea

OTC

Jan 2002

Cuba

Drug*

Jul 2002

Singapore

TPM**

Oct 2002

Mongolia

Drug*

Oct 2002

Nambia

CAM**

Aug 2003

Kazakhstan

Prescription drug

Jan 2004

Ivory coast

Functional product***

Mar 2005

Dantonic

®

Worldwide Markets (2)

*

Drug:

there is no clear classification between prescription drugs and OTC in some developing countries

**

TPM:

Traditional Patent Medicine;

CAM:

Complementary and Alterative Medicine;

TM:

Traditional Medicine;

TCM:

Traditional Chinese Medicine;

***

Functional product:

Similar to dietary supplement or food supplement;Slide30

Dantonic®

Worldwide Markets (3)

South Africa

CAM**

Sep 2005

Vietnam

Prescription drug

Oct 2005

Russia

Prescription drug

Dec 2005

Nigeria

CAM**

Dec 2006

India

Functional product***

Mar 2007

Thailand

TM**

Feb 2008

Hong Kong

TCM**

Mar 2008

Canada

OTC

Jul 2008

Philippines

OTC

Jul 2009

Uganda

Functional product***

Aug 2009Slide31

31Di’ao

Xinxuekang

Capsule - the 1

st

authorised THM from outside the EU

Approved by Dutch Medicines Evaluation Board (MEB) on

14 March 2012

The application was evaluated very carefully on the basis of:

pharmaceutical

qualitysafety

and

the justification of traditional use, i.e. 30/15 year rule

(

Dioscorea

nipponica

rhizome)

The marketing authorisation holder is obliged to implement a

pharmacovigilance

system

The manufacturing site of

Di’ao

in Chengdu, China wasinspected on GMP by the Dutch Pharmaceutical Inspection.Slide32

Email Addresses for Regulatory Agencies in various regions Australia ---

http:/www.tga.gov.au/cm/cm.htm#argcm

Canada--http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html

China---http://www.sfda.org.cn/

Hong Kong Chinese Medicine Division--http://www.cmchk.org.hk/cm/english/idx_ord.htm

The European Agency for the Evaluation of Medicinal Products— http:www.emea.eu.int/

USA-- -FDA---http://www.fda.gov/cder/guidance/index.htmSlide33

Pharmacopoeia of various countries or regions that have monographic standards for

CMM

Chan

K, Leung KS, Zhao SS. Harmonization of monographic standards

is needed

to ensure the quality of Chinese medicinal materials.

BMC-Chin Med 2009

; 4: 18

Pharmacopoeia

and

monograph

Authority Status

WHO Monographs on Selected Medicinal Plants

WHO

unofficial

Chinese Pharmacopoeia

SFDA

China official

AU Regulatory Guidelines for

Complementary

Medicines TGA

Australia official

European Pharmacopoeia

EDQM officialHong Kong Chinese Materia Medica Standards DHHKSAR, China

official

Japanese Pharmacopoeia PA

Japan

official

Thai Herbal Pharmacopoeia

TFDA

official

British Pharmacopoeia BPC,

UK

official

American Herbal

Pharmacopoeia

(AHP)

prívate

unofficialSlide34

34

Take home messages

Open mindedness

collaboration/cooperation/networking

Ensure good practices in

GACP, GSP, GLP, GMP & GCTP

Linking technologies,

chemometrics

& bioinformatics with regulatory requirements

Evidence-based assessment of

efficacy

&

safety

Global harmonisation of

regulatory control/

pharmaco

-vigilance system

To achieve these we need:

Updating monographic standards of CMM with R & D data

Local, national and global networking on all issues is a MUST

Recognition of industrial specifications for GCTP- proven brand-named products.

Train local human resources in coping with demand—role of university & educational institutes

Do the

utmost to establish a state of harmony between "tradition" and "modern" in the provision of global healthcareSlide35

Thank

you for your

attentionSlide36

Lets Meet again at Pharmacognosy-2015

3

rd

International Conference and Exhibition on Pharmacognosy, Phytochemistry and Natural Products

October 26-28, 2015 Hyderabad, India

Theme:

Advanced trends for the future of Herbal Drugs and Products

Website:

http://pharmacognosy-phytochemistry-natural-products.pharmaceuticalconferences.com/