HARMONIZE CLINICAL RESEARCH PRACTICES

Harmonize Clinical Research Practices



Harmonize Clinical Research Practices

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human (ICH) was established in 1990 as a tripartite venture of regulatory bodies and scientific research industry (http://apps.who.int). The main purpose of ICH is to provide a forum for constructive discussion on the real and perceived differences in technical requirements for registration of new chemicals.

Other objectives: to achieve greater consistency in the interpretation and application of technical guidelines for the registration of new active substances or products derived from biotechnology by its members, enhance the global development of drugs, reduction of redundant research, as well as to improve pharmaco-vigilance activities and quality control (http://apps.who.int).

To date, ICH has released more than 45 guidelines describing technical requirements related to specific components of the process of registration of medicines, compiled by a team of drug control authorities and the pharmaceutical industry in ICH. The scientific level of each guideline is high and reflects the current state of technology. The costs associated with full implementation of the guidelines in some cases may be significant, but allegedly this is offset by more rapid registration of new drugs in the ICH. The current term of ICH are the following: 1. To provide a forum for constructive dialogue between regulators and the pharmaceutical industry with real and perceived differences in technical requirements for product registration in the EU, U.S. and Japan to provide more timely introduction of new medicines, as well as their accessibility to patients; 2. Promoting public health with an international perspective; 3. To monitor and update the agreed technical requirements, leading to the strengthening of mutual recognition of research and development data; 4. In order to avoid future different requirements by aligning individual issues necessary as a result of therapeutic progress ...