Title: Achievements since Thailand meeting 2001 Introduction to the Conference Program
1Achievements since Thailand meeting
2001Introduction to the Conference Program
IFPMA Asia regulatory Conference Beijing 5-7
April 2004
Chair IFPMA Asia Regulatory Committee Co-Chair
ICH-GCG
2Bangkok meeting in 2001 a success
- Most of the Asian countries represented at the
highest level -
- Good interaction between the participants
- A important step for new initiatives
- At Regional and Country level
- Within Industry
- Influence on the ICH process
3Since Bangkok
- Regular meetings at regional level
- ASEAN ACCSQ/PPWG
- Sept 2001 Bali, Sept 2002 Siem Reap, July 2003
- Myanmar
- APEC conferences on E5
- implementation
- Taipei May 2001, Tokyo September 2002, Taipei
- November 2003
4Intense regulatory activitiy at country level
- A few examples
- Korea new regulatory legislations January-April
2002 - China regulation on registration and clinical
trials 2002 - Vietnam, Cambodia new regulations 2002
5Industry Committees
- IFPMA Asia Regulatory Committee officialized
- EFPIA IRAG creation (International Regulatory
Affairs Group) after ABPI TRAG - PhRMA IRAC
- Regular interaction between working groups
liaison members, teleconferences
6Main difficulties identified by industry
- Local specific requirements (real added value for
public health?) - Lack of consistency with some ICH GLs outcomes
- Risks of duplication
7Main topics in discussion
- Validation and API GMP issues
- Zone III and IV stability GL
- Local clinical trials and bridging studies (E5)
- CTD
- Free sales certificates and Educational Programs
8Progress has been made, but sometimes too limited
- Pragmatic attitude i.e. implementation of E5 GL,
but different from a country to another - Direct contacts between authorities and industry
representatives, invitation to participate in
regulators meetings - Workshops on technical issues i.e. validation
ASEAN region (2003) - Training activities i.e. drug development and
review process in Thailand (2003)
9An opportunity the new ICH GCG (I)
- Initially (since 1999) interaction with ICH
process, based on exchange of information and
participation in meeting - Partnerships in Harmonisation Symposium
organised with and for non-ICH regions/ countries
at ICH6 (Osaka November 2003) - Participation of non ICH experts in GCG
preparatory meetings - Program drafted and speakers identified jointly
10An opportunity the new ICH GCG (II)
- Decisions made by ICH SC (Nov 2003)
- To propose regions having harmonisation
activities to designate a permanent
representative in the GCG (APEC, ASEAN, GCC,
PANDRH, SADC) - To organize better interaction with regions
- GCG agenda
- Addressing questions and comments on ICH
- GL, particularly at step 3 and at
implementation - stage
- Proposing to ICH SC topics and harmonisation
actions
11The new GCG how in practice
- Official letter sent by GCG chairs to regions
identified (December 2003) - Designation of participants to GCG on the way
- Objective preparing the next ICH GCG agenda and
participating in the meeting June 2004 Washington
DC
12Beijing 4th IFPMA Asia Regulatory Conference
- Program built in order to address the main topics
in discussion - Interaction between regulators (countries/regions)
and industry/companies - Trying to define pragmatic solutions to issues
identified
134th Asia Regulatory Conference
- Plenary sessions on main issues
- CTD and e-CTD, GCP and Clinical Trials, Ethnic
Factors and Acceptability of Foreign Clinical
Data, Good Regulatory Practices, Quality in
Pharmaceuticals, Pharmacovigilance - Parallel workshops on specific important issues
in regions or countries - Asean CTR/CTD, Clinical Trial in China,
implementation of E5 in Asia, Good Regulatory
Practices - Time for discussion in each session
14Conclusion
- Many events since the 2001 Bangkok meeting
(progress and difficulties) - More and more regional harmonisation, but also
some local decisions which might complicate
and/or delay the patients early access to new
drugs - Partnership a key word, positive complementary
activities between regulators and industry - An opportunity the new GCG
- The 4th IFPMA Asia Regulatory Conference has been
built to match these needs