Regulatory Standard - ICH

1. The Language of Quality
for Pharmaceutical Products
Dr. Md. Shah Amran
Professor
Faculty of Pharmacy, Dhaka University
It contains
-GMP
-ISO
-TQM
-Validation
-TRIPS
-Regulatory Affairs

2. International Conference on Harmonization ( ICH)
The European Medicines Agency publishes guidelines that are harmonized between
Europe, Japan and the United States of America by the International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH).
The Need to Harmonize
The realization that it was important to have an independent evaluation of medicinal
products before they are allowed on the market was reached at different times in
different regions. However in many cases the realization was driven by tragedies, such
as that with thalidomide in Europe in the 1960s. For most countries, whether or not they
had initiated product registration controls earlier, the 1960s and 1970s saw a rapid
increase in laws, regulations and guidelines for reporting and evaluating the data on
safety, quality and efficacy of new medicinal products. The industry, at the time, was
becoming more international and seeking new global markets, however the divergence
in technical requirements from country to country was such that industry found it
necessary to duplicate many time-consuming and expensive test procedures, in order to
market new products, internationally. The urgent need to rationalize and harmonize
regulation was impelled by concerns over
- rising costs of health care,
- escalation of the cost of R&D and
-the need to meet the public expectation that there should be a minimum of delay in
making safe and efficacious new treatments available to patients in need.

3. Initiation of ICH
Harmonisation of regulatory requirements was pioneered by the European Community
(EC), in the 1980s, as the EC (now the European Union) moved towards the
development of a single market for pharmaceuticals. The success achieved in Europe
demonstrated that harmonisation was feasible. At the same time there were bilateral
discussions between Europe, Japan and the US on possibilities for harmonisation. It
was, however, at the WHO International Conference of Drug Regulatory Authorities
(ICDRA), in Paris, in 1989, that specific plans for action began to materialise. Soon
afterwards, the authorities approached International Federation of Pharmaceutical
Manufacturers Association (IFPMA) to discuss a joint regulatory-industry initiative on
international harmonisation, and ICH was conceived. The birth of ICH took place at a
meeting in April 1990, hosted by (European Federation of Pharmaceutical Industries
Association (EFPIA) in Brussels. Representatives of the regulatory agencies and
industry associations of Europe, Japan and the US met, primarily, to plan an
International Conference but the meeting also discussed the wider implications and
terms of reference of ICH. At the first ICH Steering Committee (SC) meeting of ICH
the Terms of Reference were agreed and it was decided that the Topics selected for
harmonisation would be divided into Safety, Quality and Efficacy to reflect the three
criteria which are the basis for approving and authorising new medicinal products.

4. The Evolution of ICH
For two decades the ICH process has achieved much success. This success is attributed not only
to a process of scientific consensus developed between industry and regulatory experts, but also
to the commitment of the regulatory parties to implement the ICH Tripartite Harmonised
Guidelines and recommendations. Since ICH's inception in 1990, the ICH process has gradually
evolved. ICH's first decade saw significant progress in the development of Tripartite ICH
Guidelines on Safety, Quality and Efficacy topics. Work was also undertaken on a number of
important multidisciplinary topics, which included MedDRA (Medical Dictionary for Regulatory
Activities) and the CTD (Common Technical Document). As ICH started into a new millennium,
the need to expand communication and dissemination of information on ICH Guidelines with
non-ICH regions became a key focus. Attention was also directed towards facilitating the
implementation of ICH Guidelines in ICH's own regions.
Throughout the second decade the development of ICH Guidelines continued, but with more
attention given to the need to maintain already existing Guidelines as science and technology
continued to evolve. The need to leverage with other organisations was also acknowledged,
particularly for the development of electronic standards. The SC recognised the benefits afforded
by collaboration with Standards Development Organisations, not only from the perspective of
having a larger available pool of technical expertise, but also the opportunity to progress ICH
standards as global standards.
Entering into its third decade of activity, ICH's attention is directed towards extending the
benefits of harmonisation beyond the ICH regions. Training, as well as active participation of
non-ICH regions in guideline development, are seen as key in this effort.

5. Classification ICH guidelines
The ICH topics are divided into four categories and ICH topic codes are
assigned according to these categories.
(i) Quality Guidelines
(ii) Efficacy Guidelines
(iii) Safety Guidelines
(iv) Multidisciplinary Guidelines

6. (i) Quality Guidelines
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.
(ii) 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
(iii) Safety Guidelines
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.
(iv) 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).