Pharmaceutical Research by 93l430Nn

VIEWS: 0 PAGES: 17

									 TOWARDS ICH
HARMONISATION
          History of the ICH
Rapid increase in laws, regulations and guidelines for
reporting & evaluating data on safety, quality & efficacy
Different regulatory systems based on same fundamentals
Harmonisation pioneered by EC – 1980’s as EC moved
towards development of a single market
Same time bilateral discussions between EU, US & Japan
on possibilities of harmonisation
At ICDRA conference in Paris in 1989, specific plans of
action
ICH was formed in April 1990 in Brussels
The ICH “process” was 1st drawn up at a Steering
Committee meeting in Washington, March 1992 and
amended in Tokyo, September 1992
           ICH principles
Development of scientific consensus through
discussions between regulatory and industry
experts
Wide consultation of the draft consensus
documents through normal regulatory channels
before a harmonised text is adopted
Commitment by regulatory parties to implement
ICH harmonised texts
                    ICH structure
Joint initiative involving regulators & industry as
equal partners
Founder Members:
European Commission (EU); European Federation of Pharmaceutical
Industries & Associations (EFPIA); Ministry of Health, Labour & Welfare,
Japan (MHLW); Japan Pharmaceutical Manufacturers Association (JPMA);
US Food and Drug Administration (FDA); Pharmaceutical Research &
Manufacturers of America (PhRMA)
Observers:
WHO; European Free Trade Area (EFTA), Health Canada; IFPMA
Administration:
ICH is administered by the Steering Committee (6 co-sponsors have 2 seats)
supported by the ICH Secretariat; The observers nominate non-voting
participants to attend ICH Steering Committee meetings
ICH commitment and process
Topics selected for harmonisation would be
divided into Safety, Efficacy and Quality to reflect
the 3 criteria which are the basis for approving
new medicines
Expert Working Groups (EWGs) set up to discuss
scientific & technical aspects of each
harmonisation topic
11 Topics selected for 1st ICH conference
Over 50 ICH guidelines finalised
EWG’s meet in same week as SC, report progress
to SC
           ICH Process
Initiation of ICH harmonisation action
Full ICH process for major harmonisation
topics
Abbreviated process for maintenance of
ICH agreements
Initiation of ICH harmonisation
              action
Proposals for harmonisation action
New types of medicines; Lack of harmonisation in current technical
requirements; Transition to technically improved testing procedures;
Review & maintenance of existing ICH guideline

Preparation of a concept paper
(i) Type of harmonisation action proposed, e.g. tripartite harmonised
guideline/recommendation or amendment/update of existing guideline;
(ii) Statement of the perceived problem (iii) Issues to be resolved (iv)
Background to the proposal (v) Type of expert working group

Selection of Procedure
    Full ICH process for major
       harmonisation topics
Topic selection
Steering committee action
(i) Confirm the Objectives and Expected Outcome of the harmonised action (ii)
confirm composition of EWG (iii) set timetable and action plan for EWG (iv)
revise concept paper to reflect decisions made
Expert Working Groups
Each of the 6 ICH parties (EC, EFPIA, MHLW, JPMA, FDA, PhRMA)
designates a Topic Leader for the new topic who will participate in EWG
meetings. 3 Observers to ICH invited to nominate an expert to the EWG.
Secretariat can invite designated organisations to nominate an expert
Timetable and action plan
Steering Committee wil agree on timetable for development of scientific
consensus in the EWG, not normally > 2 years
      5 Steps in the ICH process
Consensus building
Rapporteur prepares initial draft of a guideline/rcommendation for comment
with fixed deadline for comment (fax, e-mail). Interim report made to SC
meeting, if consensus is reached, sign-off - all members
Start of regulatory action
Wide ranging regulatory consultation
EU: published as a draft CPMP guideline; US: published as a draft guidance
in the Federal Register; Japan: translated & issued by MHLW for internal
and external consultation. A Regulatory Rapporteur is dessignated to draw up
the final document and sign-off
Adoption of a tripartite harmonised text
Both regulatory and industry parties of SC must be satisfied. Adoption takes
place on the signatures from the 3 regulatory parties to ICH, affirming that the
Guideline is recommended for adoption by the 3 regulatory bodies
Implementation
   Abbreviated process for
maintenance of ICH agreements
Contact network for maintenance of guidelines
Each of the 6 ICH parties establish a network of experts for dealing with
maintenance issues and identify 1 maintenane contact for each step 5 ICH
implemented agreement

Procedure: Maintenance Network
(i) Concept Paper, issues to be resolved very specific. If Coordinators agree
that it is a “minor” change, the maintenance process is initiated; (ii) Review
& sign-off: Secretariat registers maintenance proposal, regional & internal
consultation & when agreement is reached - SC

Procedure: Steering Committee
(i) Accepted & implemented immediately (ii) Accepted but requires further
consultation – Step 2 (iii) Further issues to be discussed at next SC meeting
                  Future of ICH
ICH 5, San Diego, November 2000, took
opportunity to evaluate results of past 10 years and
identify future needs
Global co-operation:
The ICH Global Co-operation Group (GCG) was formed as a sub-
committee of the ICH SC. Purpose: To make information available on
ICH, ICH activities & ICH Guidelines to any country or company that
requests the information. It is made up of 1 representative from each of
the 6 parties on the ICH SC plus ICH secretariat
New ways of working together, alternate
approaches to traditional ICH model of EWGs,
making use of modern electronic communication
Revised ICH Terms of Reference
 Maintain forum of constructive dialogue between
 regulatory authorities and pharmaceutical industry on the
 real & perceived differences in the technical requirments
 for product registration
 To contribute to the protection of public health from an
 international perspective
 To monitor and update harmonised technical requirements
 To facilitate adoption of new or improved technical
 research & development approaches which update / replace
 current practices
 To facilitate the dissemination & communication of
 information on harmonised guidelines & their use as to
 encourage the implementation & integration of common
 standards
     Criteria for designing
   “Regional Harmonisation”
Principle of harmonising drug regulations across a
defined group of countries
Harmonisation initiatives should be science based
Region initiatives should be currently active and
meetings regularly scheduled
Informtion should be disseminated about ICH
Global Cooperative group (GCG) initiatives to
members
  Regions Harmonisation Initiatives
 currently identified as matching the
               criteria
ACCSQ:ASEAN Consultative Committee for
standards and Quality
APEC joint research project on bridging studies
GCC the Gulf Co-operation Countries
PANDRH: the Pan American Network on Drug
Regulatory Harmonisation
SADC the Southern African Development
Community
   Benefits of harmonisation
Improved quality of medicines
Elimination of duplicative effort
Optimising utilisation of resources
Strengthening of individual regulatory
agencies
Standardisation of regulatory requirements
Effective medicine regulation
           The Realities…
Implementation approaches must address the
  realities of countries involved:
  Regulatory capacity
  Regulatory capabilities based on size and
  resources
  Expertise available
             Quo Vadis?
Search for a common goal
- focus on the promoting of public health
Political will
- Governments commitment to
harmonisation
Training for regulators as well as industry
- training facilitates the harmonisation
process

								
To top