Mr. DING JIANHUA

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Partnership with APEC -LSIF -One regional
example of regulatory harmonization and
challenges faced in implementation of ICH
guidelines

• Mr. DING JIANHUA
• DEPARTMENT OF DRUG REGISTRATION
• STATE FOOD AND DRUG ADMINISTRATION
• 5th IFPMA ASIAN Regulatory Conference
• Kuala Lumpur, Malaysia, March. 2008,

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GCG Mission

• To promote a mutual understanding of regional
  initiatives in order to facilitate harmonization
  processes related to ICH guidelines regionally
  and globally and to strengthen the capacity of
  drug regulatory authorities and industry to
  utilize them

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What is RHI?

• RHI stands for Regional Harmonization
  Initiatives.
• A region of member countries to achieve regional
  harmonization objectives at selected technical
  guidelines and related areas, by economic and
  politic supports.
• RHI is defined and invited by ICH SC

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Who is RHI?

• AEPC-LSIF(Life Science and Innovation Forum)-
  Asia-Pacific Economic Cooperation
• ASEAN( PPWG-Observer)-Association of the
  Southeast Asian Nations
• GCC- Gulf Cooperation Countries
• PANDRH- Pan American Network for Regulatory
  Harmonization
• SADC- Southern African Development Community

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APEC LSIF Representatives

• First representative to ICH GCG
• Mr. Jianhua Ding, the Director of Division of
  Pharmaceuticals, Department of Drug Registration,
  SFDA, appointed by APEC SOM, in June 2006
• Second representative to ICH GCG
• Dr. Dong Sup Kim, the Director of Drug
  Evaluation Department, KFDA, in May 2007

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What RHI do in ICH meeting?

• RHI inner pre-meeting to address issues to GCG
• Participate in GCG discussion and suggest to
  certain topics
• Listen to each ICH SC, EWG, IWG discussions open
  to RHI, during the time of regular meeting in
  drafting/reversion
• Make suggestions for some topics asked by chair
  person

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What RHI gained from ICH?

• Good understanding of the guidelines from the
  start of drafting and discussion period
• Good interpretation of the guidelines for home
  language-RHI know the story behind
• Good communications established with ICH experts
• Good training activities by allocating qualified
  experts

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What we do between RHI?

• Information sharing in a broad way of experiences
  for related regulatory issues
• Exchange ideas and experience in
  adoption/adaptation ICH guidelines
• Open training and capacity building opportunities
  to each other

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What we contribute to ICH?

• Make collective suggestions to ICH GCG regarding
  better implementation, especially for non-ICH
  region
• Share ICH adoption/adaptation experiences in
  non-ICH region to ICH GCG to make future decision
  of strategy building.
• Realization the real needs of non-ICH region in
  implementation and training

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APEC activities

• ICH Q8/Q9/Q10 workshop Sep 2008, Seoul. 200
  participants, successfully achieved the goal of
  understanding, communicating, and implementing
• APEC workshop on clinical trial assessment
  (Bangkok, March, Aug. 2008)
• APEC workshop on GCP inspection(Bangkok June,
  Nov. 2008)

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APEC hot harmonization topics

• Regulatory Symposium
• Bridging study
• Stability under special climate zone
• Clinical trials
• Inspections in GMP/GCP
• Quality in Q8/Q9/Q10
• Clinical data sharing among Korean, Japanese and
  Chinese

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The prospective for future

• ICH guidelines is to be more adopted/adapted by
  non-ICH region respectively.
• ICH need to be more open to non-ICH region
  expertise to gain international inputs for better
  guideline establishing.
• ICH GCG will need to go to the non-ICH regions
  for more implementation activities, such as
  workshops organized in APEC

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THANK YOU for your attention