ICH (InternationalConference on Harmonization) Guidelines
The ICH topics are
divided into four categories and ICH topic codes are assigned according to
these categories.
Harmonisation
achievements in the Quality area include pivotal milestones such as the conduct
of stability studies, defining relevant
thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good
Manufacturing Practice (GMP) risk management.
ICH has produced a
comprehensive set of safety Guidelines to
uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A
recent breakthrough has been a non-clinical testing strategy for assessing the
QT interval prolongation liability: the single most important cause of drug
withdrawals in recent years.
Efficacy Guidelines
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.
Multidisciplinary Guidelines
Those are the
cross-cutting topics which do not fit uniquely into one of the Quality, Safety
and Efficacy categories. It includes the
ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the
development of Electronic Standards for the Transfer of Regulatory Information
(ESTRI).
WHO (World Health Organization) Guidelines
MHRA (Medicines and Healthcare products Regulatory Agency) Guidelines
Other medicines regulatoryguidance
Safety guidance
Safety information
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