FHH Reference Standard

Necessity of a new Mission

Subcommittee 2

• The given task almost achieved
• The necessity of a new mission for the next 10 years

A New Mission

• Studies on establishment

of FHH Herbal Reference Standards

Herbal RS

• Chemical Reference Standards / CRS
• Reference Medicinal Plant Materials / RMPM

Why?

• Because FHH RMPM would be most likely needed as international standards for mutual recognition of herbal medicines in the era of RCEP

Roadmap in 2013

Thank you

Jeju island in winter

• June

- Hold a discussion on the isuue in Korea

• July - Oct

- Get feedback for 4 months

• Nov

- Report main points of results

Why Now?

How?

Subcommittee 2

• Hold a meeting on this Issue in 2013

- Necessity, Possibility and Availability Check

• Report the result to Standing Committee in 2013

For What?

• FHH should prepare for the era of the single market such as EU, NAFTA

Why Now?

• The negotiation among RCEP on a free trade agreement was started on Nov 21, 2012

RCEP : Regional Comprehensive Economic Partnership

• RCEP has 16 member countries including Australia, China, Japan, Korea, Singapore, Vietnam etc

Sale Catalogue of KP RMPM

Certificate of KP RMPM

• Origin
• Lot No
• Photos
• Identification Test
• Storage Condition
• Expiration
• Manufacturing Date etc

Total 99 items, powdered

Sales Volume of KP RMPM

RMPM : Reference Medicinal Plant Materials

A New Mission

• Studies on establishment of FHH RMPM

A proposal

Aims of FHH

Role of FHH Subcommittee

1

2

3

• To provide a scientific basis for improvement or development of standards in safety, quality and efficacy of herbal medicines
• To reduce duplication of efforts
• To create economic use of valuable resources
• To address lack of standards in areas of public health importance to regulatory agencies

2003-2004 China

2005-2006 Japan

2007-2008 Korea

2009-2010 Hongcong

2011-2012 Vietnam

• ADR
• Counterfeit

• Nomenclature
• Criteria
• Method Validation

• GAP
• GMP
• Website

FHH Timeline

• The Application of Quality Assurance on GAP and GMP
• The website for information exchange

dididirdp eogks - dirdp eogks Studies on Establishment of

FHH Herbal Reference Standards

Outcomes of FHH Subcommittee 2

Shin-Jung Kang, Director General / Ph.D.

Pharmaceuticals & Medical Devices Research Department

NIFDS

KFDA

Korea Food & Drug Administration

scientific evidences

In setting

KFDA's policies

NIFDS

National Institute

of Food & Drug Safety Evaluation

Necessity of a new Mission

• Subcommittee 2 recognized

the necessity of a new mission

for the next 10 years

Current Status of Worldwide RMPM

• CP 390 RMPM among 615 monographs
• KFDA 99 RMPM among 547 monograph in KP
• USPC 28 RMPM among 116 monographs in DSC
• EDQM 18 RMPM among 212 monographs in EP

CP : Chinese Pharmacopeia

KP : Korean Pharmacopeia

USP : United State Pharmacopeia

EP : European Pharmacopeia

DSC : Dietry Supplement Compendium