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Challenges, trends and Strategies in TCM Development. May 17 th 2011 | Beijing, China. Unique Potential for Innovation in China. Traditional Chinese Medicine. Translational Medicine. Jing’an, Shanghai, March 2011. TCM is One of Fastest Growing Therapy Areas.

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Unique potential for innovation in china
Unique Potential for Innovation in China

Traditional Chinese Medicine

Translational Medicine

Jing’an, Shanghai, March 2011

Tcm is one of fastest growing therapy areas
TCM is One of Fastest Growing Therapy Areas

Kanpo Medicine: System of herbal medicine practiced in Japan by both herbalists and practitioners of modern medicine. Kampo originated in China and is based on Chinese herbal medicine

What is modernised tcm
What is Modernised TCM?




  • Good Agriculture Practice (GAP) certificate:

  • Ensures TCM herbs and raw ingredients are clean and fit for human consumption and that they contain the effective ingredients

  • TCM medicine manufacturers usually do not need this certificate, but suppliers may be chosen according to whether or not they have this certificate

  • >99 GAP bases in 22 provinces covering 49 different herbs.

  • Good Supply Practice (GSP) certificate:

  • Introduced in 2001, it is necessary if a company seeks to develop an internal distribution and supply network

  • Foreign companies generally are not able to attain this certificate, but domestic subsidiaries can.

  • Good Laboratory Practice (GLP) certificate:

  • Beginning in 2007, all non-clinical drug research must be carried out in a GLP certified facility

  • Good Clinical Practice (GCP) certificate:

  • Since 1999, GCP certifications are necessary to perform clinical trials on a drug to determine its quality and efficacy

  • Good Manufacturing Practice (GMP) certificate:

  • The requirement for all drug manufacturers to have this certificate came into effect at the beginning of 2004

  • All TCM makers must have this certificate or they are subject to suspension.

  • Good Extraction Practice (GEP) certificate:

  • This covers the first step of the TCM manufacturing process, which ensures quality and use of TCM products


Protect innovation patent law regulations
Protect Innovation: Patent Law & Regulations

No of TCM Patents

Before 1st amendment to Chinese Patent Law in 1993, there was no patent protection for pharma product or food

  • Chinese Patent Law recognises composition of matter, method & use claims

  • Can be easy to design around (e.g. change composition mix, change extraction method)

  • Difficult to enforce (e.g. difficult to prove infringer used same method)

Sfda regulations revised in 2007
SFDA Regulations Revised in 2007


Since 2007

New TCM drug approvals:

2009: 72

2010: 10

A new era of evidence based tcms
A New Era of Evidence Based TCMs

Development attrition risk likely lower than NCE :

Many promising new chemical drugs have failed to deliver efficacy

Efficacy for TCMs based on many years of (anecdotal) clinical experience,

Many years of non-controlled clinical use = low risk of unexpected safety issues


Clear regulatory pathway for TCM in China and major markets(SFDA Guidance 2007,FDA Guidance 2004, EU Directive 2004)

New requirements for evidence represent significant barrier for most TCM companies

Competitors who choose to develop same/similar TCMs must produce data to support their claims to the same standard as the innovatorSimilar to biosimilars, represents major barrier to entry

Government: 2007 Party Congress support increased role for TCM in healthcare

Encouraged private sectors investment, TCM heritage protection

TCM innovation/modernization

More TCM use for Primary care, Essential Drug List, National Reimbursement Drug List

Global market is an aspiration

Tcm botanicals a global opportunity
TCM/Botanicals: A Global Opportunity

US & EU have regulatory guidelines for botanical drugs

US: FDA Guidance for Industry: Botanical Drug Products, June 2004

EU: Directive 2004/24/EC, amending Directive 2001/83/EC, April 30, 2004

Guideline On Declaration Of Herbal Substances And Herbal Preparations In Herbal Medicinal Products/Traditional Herbal Medicinal Products (EMA/HMPC/CHMP/CVMP/287539/2005 Rev 1), March 11, 2010

List of Questions and Answers (Q&A) Received During the HMPC Assessors Training on Quality Issues Emerging for Herbal Medicinal Products (EMEA/531300/2008, November 6, 2008

Guideline on Selection of Test Materials for Genotoxicity Testing for Traditional Herbal Medicinal Products/Herbal Medicinal Products (EMEA/HMPC/67644/2009) November 12, 2009

Reflection Paper on Markers used for Quantitative and Qualitative Analysis of Herbal Medicinal Products and Traditional Herbal Medicinal Products (EMEA/HMPC/253629/2007) July 15, 2008

Guideline on the Quality of Combination Herbal Medicinal Products/Traditional Herbal Medicinal Products (EMEA/HMPC/CHMP/CVMP/214869/2006) June 23, 2008

Guideline on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products (CPMP/QWP/2819/00 Rev 1, EMEA/CVMP/814/00 Rev 1), March 30, 2006

Guideline on specifications: Test Procedures And Acceptance Criteria For Herbal Substances, Herbal Preparations And Herbal Medicinal Products/Traditional Herbal Medicinal Products (CPMP/QWP/2820/00, EMEA/CVMP/815/00) March 30, 2006

Early experience

Veregen is the only botanical approved in US (MediGene AG, 2006)

Green tea extract for condyloma acuminata

Hutchinson Pharma’s HMPL-004 for IBD completed Phase II in US

Tasly’s Danshen Dripping pill has completed Ph II

1 st may 2011 a watershed for tcm in eu
1st May 2011: A Watershed for TCM in EU

Tcm drug development challenges
TCM: Drug Development Challenges

Right Patient

Right Drug

Right Dose

Western or Chinese concepts of disease?

Traditional combinations or select herbs based on pharmacology


Maximum tolerated dose?

Dose ranging?

Placebo control?


Double blind?

Active control?