Гармонизация требований к лекарственным средствам для защиты общественного здоровья.

Initiative to promote public health
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements."

The WG works to prepare a consensus draft of the Technical Document, based on the objectives set out in the Concept Paper. When consensus on the draft is reached within the WG, the technical experts of the WG will sign the Step 1 Experts sign off sheet. The Step 1 Experts Technical Document is then submitted to the Assembly to request adoption under Step 2 of the ICH process.

Step 2a is reached when the Assembly agrees, based on the report of the WG, that there is sufficient scientific consensus on the technical issues for the Technical Document to proceed to the next stage of regulatory consultation. The Assembly then endorses the Step 2a Technical Document.

Step 2b is reached when the Regulatory Members of the Assembly further endorse the draft Guideline.

Step 3 occurs in three distinct stages: regulatory consultation, discussion, and finalisation of the Step 3 Expert Draft Guideline. Stage I Regional regulatory consultation: The Guideline embodying the scientific consensus leaves the ICH process and becomes the subject of normal wide ranging regulatory consultation in the ICH regions. Regulatory authorities and industry associations in other regions may also comment on the draft consultation documents by providing their comments to the ICH Secretariat. Stage II Discussion of regional consultation comments: After obtaining all comments from the consultation process, the EWG works to address the comments received and reach consensus on what is called the Step 3 Experts Draft Guideline. Stage III Finalisation of Step 3 Experts Draft Guideline: If, after due consideration of the consultation results by the WG, consensus is reached amongst the experts on a revised version of the Step 2b draft Guideline, the Step 3 Expert Draft Guideline is signed by the experts of the ICH Regulatory Members. The Step 3 Expert Draft Guideline with regulatory EWG signatures is submitted to the Regulatory Members of the Assembly to request adoption at Step 4 of the ICH process.

Step 4 is reached when the Regulatory Members of the Assembly agree that there is sufficient scientific consensus on the draft Guideline and adopt the ICH Harmonised Guideline.

The ICH Harmonised Guideline moves immediately to the final step of the process that is the regulatory implementation. This step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements in the ICH regions. Information on the regulatory action taken and implementation dates are reported back to the Assembly and published by the ICH Secretariat on the ICH website.

MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, vaccines and drug device combination products.