Chemistry Reference
In-Depth Information
reviewed and revised by the EWG until a consensus is reached on the scientific issues.
The draft is then forwarded by the EWG to the steering committee for further action.
1.4.3.2 step 2
At the next step, the draft is approved by the six ICH parties in the steering com-
mittee and is transmitted to the three regional regulatory agencies for formal con-
sultation. This regulatory consultation may include organizations and associations
outside the ICH process, as well as the IFPMA, EFPIA, JPMA, and PhRMA, and
the observers WHO, EFTA and the Drugs Directorate, Health Canada. This com-
ment period is normally six months, except when there are special circumstances.
1.4.3.3 step 3
Next, a regulatory rapporteur is designated from the EU, MHW, or FDA to collect
comments in the three regions. The rapporteur, in consultation with the other regu-
latory experts, analyzes the comments and amends the “Step 2” draft if necessary.
If, as a result of this process, significant change results and the original consensus
is not maintained, one or more regulatory authorities may recirculate the amended
parts of the draft for further approval. If amendment is not necessary, the rapporteur
prepares a final draft and seeks the approval of the regulatory experts from the other
parties. The final draft is “signed off” by experts designated by the regulatory parties
before being referred to the ICH Steering Committee for adoption.
1.4.3.4 step 4
The final draft is discussed within the Steering Committee and “signed off” by the
three ICH regulatory parties and recommended for adoption.
1.4.3.5 step 5
The process is complete when the full recommendations are incorporated into domes-
tic regulations or other appropriate administrative measures, according to national/
regional internal procedures. In the United States, during both the comment period
(Step 2) and implementation (Step 5), the full text of the guideline is published in
the
Federal Register
and eventually will end up in the appropriate compendia, such
as the
US Pharmacopeia
. Guidelines are also available via the Internet. Each of the
other regulatory parties has its own implementation process, and they make them
available via the Internet as well.
1.4.4 Ich h
ArmonIzAtIon
I
nItIAtIveS
ICH harmonization topics to date have been divided into several major categories with
ICH codes assigned to each topic. The guidelines derived from each topic are commonly
referred to by the ICH codes. These categories include Quality topics (“Q”-topics relat-
ing to pharmaceutical quality assurance), Safety topics (“S”-topics relating to in vitro
and in vivo preclinical studies), Efficacy topics (“E”-topics relating to clinical studies in
humans), and Multidisciplinary topics (“M”-topics that defy categorization).
Method validation guidelines fall under the Quality topics, in Section Q2,
Validation of Analytical Procedures. The harmonized ICH text of Topic Q2A:
