第一篇：國際人用藥品注冊和醫(yī)藥技術(shù)協(xié)調(diào)會議工作程序介紹 (ICH)

Formal ICH Procedure(Category 1)

This procedure corresponds to the original ICH process and was used for more than a decade, and it now includes some additional explanation on each activity.The Steering Committee may decide to follow an accelerated procedure for new topics, when necessary.To this end, the Steering Committee adopted the Streamlined Procedure(final version dated October 21, 2002)in Washington in September 2002.Step 1: Consensus building When the Steering Committee adopts a Concept Paper as a new topic, then the process of consensus building begins.As requested in the Concept Paper, an extended EWG or original EWG shall be established.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, giving fixed deadlines for receipt of those comments.To the extent possible, the consultation will be carried out by correspondence, using fax and e-mail.Face-to-face meetings of the EWG will normally only take place at the time and venue of the biannual SC meetings.Additional formal meetings of the ICH EWG need to be agreed, in advance, by the Steering Committee.Interim reports are made at each meeting of the ICH Steering Committee.When consensus is reached among all six party EWG members, the EWG will sign the Step 2 Experts Signoff sheet.If consensus is reached within the agreed timetable the Step 2 Experts Document with EWG signatures is submitted to the Steering Committee to request adoption under Step 2 of the ICH process.Where complete consensus within the six ICH parties has not been reached within the agreed time frame, a report will be made to the Steering Committee indicating the extent of agreement reached and highlighting the points on which there are differences among the parties.Experts from all parties represented on the EWG will have the opportunity to explain their position to the Steering Committee.The Steering Committee may then:

Allow an extension of the timetable, on the basis that the EWG can give assurances that consensus could be reached within a short, specified period;

Decide to suspend or abandon the harmonisation project.Step 2: Confirmation of six-party consensus Step 2 is reached when the Steering Committee agrees, based on the report of the EWG, that there is sufficient scientific consensus on the technical issues for the draft guideline or recommendation to proceed to the next stage of regulatory consultation.This agreement is confirmed by at least one of the SC members for each of the six ICH parties signing their assent.The consensus text approved by the Steering Committee is signed off by the Steering Committee as Step 2 Final Document.Step 3: Regulatory Consultation and Discussion a)Regional regulatory consultation

At this stage, the guideline embodying the scientific consensus leaves the ICH process and becomes the subject of normal wide-ranging regulatory consultation in the three regions.In the EU it is published as a draft CHMP Guideline, in Japan it is translated and issued by MHLW for internal and external consultation and in the USA it is published as draft guidance in the Federal Register.The difference from normal, national/regional procedures for consultation on guidelines are that the regulatory parties exchange information on the comments they have received in order to arrive at a single, harmonised guideline.Also, there is an opportunity for industry associations and regulatory authorities in non-ICH regions to comment on the draft consultation documents, which are distributed using IFPMA and WHO contact lists.b)Discussion of regional consultation comments

After obtaining all regulatory consultation results, the EWG who organized the discussion for consensus building will be resumed.This EWG consists of regulatory and industry parties, and Observers.If the Rapporteur was designated from an industry party until Step 2, then 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 both regulatory and industry parties of the EWG are satisfied that the consensus achieved at Step 2 is not substantially altered as a result of the consultation, or consensus is reached on any alterations, the Step 4 Experts Document is signed by the EWG regulatory experts.The Step 4 Document with regulatory EWG signatures is submitted to the Steering Committee to request adoption as Step 4 of the ICH process.This Step 4 Document with regulatory EWG signatures is named Step 4 Experts Document, and this signoff is to be called Step 4 Experts Signoff.Where complete consensus has not been achieved within the agreed time frame, a report will be made to the Steering Committee indicating the extent of agreement reached and highlighting the points on which differences between the parties remain.Experts from all parties represented on the EWG will have the opportunity to explain their position to the Steering Committee.The Steering Committee may then:

Allow an extension of the time frame, if the EWG can give assurances that consensus could be reached within a short, specified period;

Decide to abandon the current draft and resume the discussion from Step 1;

Decide to suspend or abandon the harmonisation project.Step 4: Adoption of an ICH Harmonised Tripartite Guideline Step 4 is reached when the Steering Committee agrees, on the basis of the report from the regulatory Rapporteur of the EWG, that there is sufficient scientific consensus on the technical issues.This endorsement is based on the signatures from the three regulatory parties to ICH affirming that the Guideline is recommended for adoption by the regulatory bodies of the three regions.In the event that one or more parties representing industry have strong objections to the adoption of the guideline, on the grounds that the revised draft departs substantially from the original consensus, or introduces new issues, 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 at Step 4 of the ICH process.Step 5: Implementation Having reached Step 4 the 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 USA.Information on the regulatory action taken and implementation dates are reported back to the Steering Committee and published by the ICH Secretariat on the ICH website.The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories.Q: “Quality” Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance(Stability Testing, Impurity Testing, etc.)

S: “Safety” Topics, i.e., those relating to in vitro and in vivo pre-clinical studies(Carcinogenicity Testing, Genotoxicity Testing, etc.)

E: “Efficacy” Topics, i.e., those relating to clinical studies in human subject(Dose Response Studies, Good Clinical Practices, etc.)

M: “Multidisciplinary” Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categories(MedDRA, ESTRI, M3, CTD, M5)

Notes on implementation in the three ICH Regions EU The ICH guidelines are submitted to the Committee for Human Medicinal Products(CHMP)for endorsement once they have reached Step 2 or Step 4 of the ICH Process.The CHMP, in consultation with the European Commission decides on the duration for consultation with interested parties(up to 6 months).The European Agency for the Evaluation of Medicinal Products(EMEA)publishes and distrubutes the Step 2 guidelines for comments.At Step 4 the guidelines are endorsed by the CHMP and a timeframe for implementation is established(usually 6 months).The guidelines are subsequently published by the European Commission in the Rules Governing Medicinal Products in the European Union(http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm).Step 2 and Step 4 guidelines are available from the EMEA site on the Internet: http://

EMEA Website: ICH的指導(dǎo)原則官方下載網(wǎng)址 Efficacy: http://www.emea.europa.eu/htms/human/ich/ichefficacy.htm

Safety: http://www.emea.europa.eu/htms/human/ich/ichsafety.htm

Multidisciplinary: http://www.emea.europa.eu/htms/human/ich/ichmulti.htm

Quality: http://www.emea.europa.eu/htms/human/ich/ichquality.htm