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Encyclopedia > International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) 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. Image File history File links Broom_icon. ... Image File history File links Question_book-3. ... For other uses, see Europe (disambiguation). ... This is a list of pharmaceutical and biotech companies that are major manufacturers on global or national markets : Abbott Laboratories Able Laboratories Akzo Nobel Allergan Almirall Prodesfarma Alphapharm Altana (previously Byk Gulden) ALZA, part of Johnson & Johnson Amgen AstraZeneca, formed from the merger of Astra AB and Zeneca Group PLC...


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.

Contents

History

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. For other places with the same name, see Brussels (disambiguation). ... For other uses, see Europe (disambiguation). ...


Structure

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). Berlaymont, the Commissions seat The European Commission (formally the Commission of the European Communities) is the executive branch of the European Union. ... The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... The European Federation of Pharmaceutical Industries and Associations or EFPIA is the organization representing the research-based pharmaceutical industry operating in Europe. ... The Ministry of Health, Labour and Welfare (厚生労働省; Kōsei-rōdō-shō) is one of ministries in the Japanese government. ... The Japan Pharmaceutical Manufacturers Association or JPMA is the organization representing the research-based pharmaceutical industry operating in Japan. ... “FDA” redirects here. ... Pharmaceutical Research and Manufacturers of America (PhRMA) is a trade group representing the pharmaceutical research and biotechnology companies in the United States. ...


Process

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.

Rapporteur (derived from French) is used in international and European legal and political contexts to refer to a person appointed by a deliberative body to investigate an issue or a situation, and report back to that body. ... Common description Commonly the term Guideline denotes one or more rules that describe a process. ...


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.

CHMP redirects here. ... Office building Office building The Ministry of Health, Labour and Welfare ) is one of cabinet level ministries in the Japanese government. ... The Federal Register contains most routine publications and public notices of United States government agencies. ... The IFPMA is the International Federation of Pharmaceutical Manufacturers and Associations. ... Look up who in Wiktionary, the free dictionary. ...


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.


See also

The Australia New Zealand Therapeutic Products Authority (ANZTPA) is a proposed authority which if adopted in both Australia and New Zealand will be the sole authority which regulates therapeutic goods in both countries. ... The CIOMS Guidelines, formally known as International Ethical Guidelines for Biomedical Research Involving Human Subjects, is a set of ethical principles regarding human experimentation. ... In health care, including medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a process in which a medicine or other medical treatment is tested for its safety and effectiveness, often in comparison to existing treatments. ... The Common Technical Document or CTD is a specification for applications for drug approval designed to be used across Europe, Japan and the U.S.. It was developed by the European Medicines Agency (EMEA, Europe), the Food and Drug Administration (FDA, USA) and the Ministry of Health, Labour and Welfare... The Council for International Organizations of Medical Sciences (CIOMS) is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949. ... WHO redirects here. ... Harmonization in Clinical Trials - The word Harmonization comes from Greek word Harmonia - the state of the matter or rules when all the parts are fit together. ... sex Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. ... This article or section does not cite its references or sources. ... The IFPMA is the International Federation of Pharmaceutical Manufacturers and Associations. ... Good clinical practice is a set of rules and regulations that is provided by International Conference on Harmonisation (ICH) - an international body that regulates clinical trials involving human subjects. ... A National Pharmaceuticals Policy is one that aims at ensuring that people get good quality drugs at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patients illness. ... Pharmaceutical policy is a branch of health policy that deals with the provision and use of medications within a health care system. ... Back cover of the Chinese pharmacopoeia First Edition (published in 1930) Pharmacopoeia (literally, the art of the drug compounder), in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a... The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. ... The State Food and Drug Administration (SFDA Simplified Chinese: ) is founded on the basis of the State Drug Administration. ... The Uppsala Monitoring Centre (the UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. ...

External links

  • Official ICH website

  Results from FactBites:
 
NBScience,medical conferences,GCP trainings (2479 words)
Harmonisation of regulatory requirements was pioneered by the European Community, in the 1980s, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals.
The Parties cosponsoring this Conference, represented at the 2nd Steering Committee Meeting in Tokyo, 23-24 October 1990 re-affirmed their commitment to increased international harmonisation, aimed at ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner.
The Conference, its preparations and follow-up activities will be conducted in an open and transparent manner and the presence of observers from other regulatory authorities and WHO is welcomed as a means of ensuring that the benefits of progress towards harmonisation can be utilised world-wide.
  More results at FactBites »

 
 

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