利用者:Akaniji/日米EU医薬品規制調和国際会議
日米EU医薬品規制調和国際会議[1]（にちべい—いやくひんきせいちょうわこくさいかいぎ、英：International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ）は日本、米国、EUの薬事行政官と産業界の代表からなる協議会で、3国によってまちまちである薬事規制を統一するための国際的な協議会である。
is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.
The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.
Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.
ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration.[2]
経緯
[編集]In the 1980s, what is today the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation; ICH was created in April 1990 at a meeting in Brussels, Europe.
構成
[編集]Seven parties that represent the regulatory bodies and the research-based industries of the founding members are responsible for the decision making process: the European Commission, the European Medicines Agency (EMEA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health, Labour and Welfare, the 1986 Japan Pharmaceutical Manufacturers Association (JPMA), the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).
工程
[編集]The ICH process consists of five steps:
Step 1: Expert Working Group consensus building
When the Steering Committee (SC) adopts a concept paper as a new topic, the process of consensus building begins.
A rapporteur is usually designated from the industry members of the respective six-member Expert Working Group (EWG). This EWG consists of regulatory and industry parties (one voting member of each party and region), and observers. The rapporteur prepares an initial draft of the guideline, based on the objectives set out in the concept paper, and in consultation with experts designated to the EWG. The initial draft and successive revisions are circulated for comments within the EWG.
Usually, the EWG consultation is carried out by correspondence. Face-to-face meetings of the EWG will normally only take place during the biannual SC meetings. Interim reports are made at each meeting of the SC.
If consensus is reached the EWG will sign the Step 2 Experts Signoff sheet and submit it to the SC to request adoption.
If there is no agreement in the EWG within the time frame the SC may extend the time frame, suspend or abandon the harmonization project.
Step 2: Confirmation of EWG consensus by the SC
Step 2 is reached when the SC agrees, based on the report of the EWG, that there is sufficient scientific consensus on the technical issues for the draft guideline. This text is signed off by the SC as Step 2 Final Document.
Step 3: Regulatory consultation and discussion
The draft becomes subject of consultation in the three regions. It is published in the European Union (as draft CHMP or CVMP guideline), Japan (after translation by MHLW), and the USA (as draft guideline in the Federal Register) and everybody within these regions can comment on it. There is also an opportunity for companies, associations and authorities in non-ICH regions to comment on the draft, which is distributed by IFPMA and WHO. After obtaining all consultation results, the EWG will be resumed. A new rapporteur will be appointed from the regulatory party, preferably from the same region as the previous rapporteur. The same procedure described in Step 1 is used to address the consultation results into the Step 2 Final Document. The draft document to be generated as a result of the Step 3 phase is called Step 4 Experts Document.
If industry and regulatory EWG members agree on the alterations as a result of the consultation, the Step 4 Experts Document is signed by the EWG regulatory experts only (Step 4 Experts Signoff) and submitted to the SC to request adoption as Step 4 of the ICH process.
If there is no agreement in the EWG within the time frame the SC may extend the time frame, abandon the current draft and resume the process from Step 1, suspend or abandon the harmonization project.
Step 4: Adoption of an ICH harmonised tripartite guideline
Step 4 is reached when the SC agrees that there is sufficient scientific consensus on the technical issues.
If one industry party has strong objections to the adoption of the guideline due to deviations of the revised draft from the original consensus the regulatory parties may agree that a revised document should be submitted for further consultation. In this case, the EWG discussion may be resumed.
The Step 4 Final Document is signed off by the SC signatories for the regulatory parties of ICH as an ICH Harmonised Tripartite Guideline.
Step 5: Implementation
The ICH Harmonised Tripartite 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 European Union, Japan, and the United States.
Information on the regulatory action taken and implementation dates are reported back to the SC and published by the ICH Secretariat on the ICH website.
関連項目
[編集]脚注
[編集]- ^ 和名は厚生労働省 (2004-06-17), 日米EU 医薬品規制調和国際会議ワシントン会議（運営委員会／専門家作業部会）の結果について 2009年3月22日閲覧。より。
- ^ Bankert, Elizabeth A; Robert J. Amdur (2006). Institutional Review Board. Jones & Bartlett Publishers. p. 281