13th ICH Immediate Briefing Date: December 20, 2005 Time: 10:00 ・16:00 Venue: Kudan Kaikan Hall, Tokyo Organizer: ・The Society of Japanese Pharmacopoeia (SJP) (Incorporated Foundation) ・Japan Pharmaceutical Manufacturer Association (JPMA) ・ICH Project Sponsors: ・Japan Federation of Pharmaceutical Manufacturers・Associations (JFPMA) ・The Pharmaceutical Manufacturers・Association of Tokyo (PMAT) (Incorporated Association) ・Osaka Pharmaceutical Manufacturers Association (OPMA) ・Japan Pharmaceutical Association (JPA) (Incorporated Association) PROGRAM 10:00-10:5 Opening Address from the Organizer (SJP) 10:05 ・10:35 Latest developments in ICH MHLW, Pharmaceutical and Food Safety Bureau Evaluation and Licensing Division Assistant Manager Mr. Kazuhiko Chikazawa 10:35 ・11:05 Developments in the topic of harmonization of pharmacopoeias - Q4B MHLW, Pharmaceutical and Food Safety Bureau Evaluation and Licensing Division Assistant Manager Ms. Kiyomi Ueno Break 11:20 ・11:50 Developments in the topic of pharmaceutical development ・Q8 National Institute of Health Sciences Department of Organic Chemistry Head Mr. Haruhiro Okuda 11:50 ・12:05 Q&A session 12:05 ・13:05 Lunch break 13:05 ・13:35 Developments in the topic of quality - Q9 National Institute of Health Sciences Division of Drugs, Third Section Head Mr. Yukio Hiyama 13:35 ・13:50 Q&A session 13:05 ・13:35 Newly proposed topic: GMP Quality Systems Japan Pharmaceutical Manufacturers Association ICH Project GMP Quality Systems Leader Mr. Makoto Shigemitsu 13:35 ・13:50 Q&A session 13:50 ・14:20 Newly proposed topic: Biotechnology Japan Pharmaceutical Manufacturers Association ICH Project Biotechnology Topic Expert Mr. Junichi Koga 14:20 ・14:50 Q&A session 14:50 ・15:00 Break 15:00 ・15:20 Newly proposed topic: Pharmacogenomics Japan Pharmaceutical Manufacturers Association ICH Project Pharmacogenomics Co-Leader Ms. Sanae Yasuda 15:20 ・15:30 Q&A session 15:30 ・15:50 Newly proposed topic: Risk Communication Japan Pharmaceutical Manufacturers Association ICH Project Risk Communication Co-Leader Ms. Hiroko Koyama 15:50 ・16:00 Q&A session Related Reports Disclaimer About the Periodic Information Meetings Held by the Regulatory Authorities The first of the series of periodic information meetings held by the regulatory authorities was carried out on January 29, 1999 in Tokyo with the purpose to provide direct clarification for a number of current topics (organizational changes, acceptance of ICH Guidelines, GCP and the conduct of clinical trials). The title 的CH Immediate Briefings・reflects the aim of the organizers to report promptly the most recent changes in the ICH process. Since the beginning of the series totally 49 meetings have been held as follow: Title No. New Drug Evaluation Division Information Meetings 22 ICH Immediate Briefings 13 Drugs and Medical Devices Safety Update Seminars 8 Current Issues in QA of Medicinal Products 5 14th Japanese Pharmacopoeia 1 Total as of June 2005 49 Opening Address from the Organizer: (SJP) (Gist) The active discussion concerning the ICH process for simultaneous development of medicinal products, securing their international safety and harmonizing the pharmaceutical regulations in Japan, US and Europe has already brought a number of results. It is very important to share the information on the recent developments of ICH with those responsible in the pharmaceutical industry for the product development and safety assurance, and the progress with the JPMA / SJP ICH Project and the results from the meeting of the ICH Steering Committee and its expert working groups held in Brussels in May this year as it will follow. Thereafter, our appeal is all concerned parties to participate. Note: The main organizer of the series of periodic information meetings held by the regulatory authorities is the Society of Japanese Pharmacopoeia (SJP). Although, named a society, the SJP is an organization of the Japanese regulatory authorities and until the administrative reforms of 2001 was fully subordinated to the National Institutes of Health Sciences (HIHS). Presently, the SJP is an incorporated foundation and works closely with the governmental bodies, independent administrative institutions (such as PMDA) and private industry and professional associations. SUMMARY    The 13th ICH Immediate Briefing 1 had two main objectives: 1. To introduce and explain to the regulatory professionals the outcome of the ICH Steering Committee and EWG Meetings tentatively entitled 鄭 modern harmonised approach to Pharmaceutical Quality and Manufacturing・held in Chicago, USA on November 7-10, 2005; and 2. To summarize and to present in the form of an overview any other developments occurred in the ICH process since the previous immediate briefing 2 meeting.    The introductory presentation by an official from the PFSB on 鏑atest developments in ICH・3 provided a concise summary of the main results of the Chicago meeting including the most recent news such as the scheduled dates for the future ICH Steering Committee (SC) / Expert Working Groups (EWG) Meetings in 2006 and 2007, including the forthcoming SC and EWG Meeting to be held in Yokohama, Japan on June 5-8, 2006. The key results of the 2005 Chicago meeting ・the approval of new topic Quality Systems・(Q10), and the adoption (Step 5) of the Guidelines for two other topics - 撤harmaceutical Development: Q8・and 轍uality Risk Management: Q9・were also presented.        The first of the presentations on individual topics was dedicated on the harmonization of pharmacopoeias ・Q4B 4. This topic is of relatively higher importance for Japan owning to the scheduled major revision of the Japanese Pharmacopoeia in 2006. As a step toward the Pharmacopoeial Interchangeability, the XV Edition of the Japanese Pharmacopoeia is to be published in March 2006. The present XIV Edition of the Japanese Pharmacopoeia was released in March 2001, with First Supplement in December 2002 and the Second Supplement 5 in December 2004. A dedicated information meeting on the new JP XV will be organized in May 2006 in Tokyo. The third presentation was focused on the topic of pharmaceutical development and the recent adoption of the tripartite harmonized ICH Guideline 撤harmaceutical Development: Q8・- finalized (Step 4) in November 2005. The Guideline is already approved in EU with a date for coming into operation in May 2006. In Japan, the MHLW issued in 2005 a translation of the document, however is not yet adopted. The forth presentation was centered on the topic of Quality Risk Management - Q9 6 and the recent adoption of the tripartite harmonized ICH Guideline 轍uality Risk Management: Q9・- finalized (Step 4) in November 2005, and already approved in USA. In Japan, the MHLW issued in 2005 a translation of the document, however is not yet adopted. The subsequent three presentations were focused specifically on newly proposed ICH topics (GMP Quality Systems, Biotechnology, and Pharmacogenomics) and the contribution from the Japanese participating parties. Current and future task were outlined after the endorsement by the SC of further work on the topics along with pharmacovigilance. The last presentation for the day dealt with the new topic on pharmacovigilance 7, however the emphasis of the lecture was put on the risk communication. Japan is presented in the ICH Pharmacovigilance Plenary Session by members from the regulatory authorities (MHLW, PMDA) and the industry (JPMA). Ongoing efforts are concentrated on the Concept Papers with a proposed content from MHLW on Good Pharmacovigilance Practice (敵ood case Report・ criteria for further investigations, etc.) and Risk Control and Risk Communication, and from JPMA comes a supplementary proposal in the area of Risk Communication ・on harmonization of safety information across regions including standard labeling/standard methods for distribution and contents of 泥ear Doctor (Healthcare professional)・letters. The present regulatory environment for safety reporting varies among the ICH regions as MHLW has not issued a dedicated guideline for Development Safety Update Report (DSUR) in contract to Annual Reports required by FDA and EU. Conversely, while US and EU guidelines are still being drafted, Japan has already a Guideline 8 in place for healthcare professionals and related communications. The leadership of Japan has been recognized and the Rapporteur of the EWG on 滴ealthcare Professionals and Related Communications・is proposed to be JPMA with targeted dates for finalization of the Concept Paper by the time of the next meeting in Yokohama in 2006 and completion of the work by November 2007. Related Reports on meetings held in 2005 ・ Individual reports on the New Drug Evaluation Division Regular Meetings ・18th, 19th and 20th (held in 2004), and 21st and 22nd (in 2005): Available in the JKS Document Store ・Report on the 泥rugs and Medical Devices Safety Update Seminar・held in Tokyo on September 16, 2005 Available in the JKS Document Store Disclaimer This publication is based on information obtained through in-house research and from sources available to public and it is not a complete analysis of every material fact. Statements of fact have been obtained from sources considered reliable but no representation is made as to their completeness or accuracy. Whilst the utmost care has been taken in the preparation of Jouhou Koukai Services and Jouhou Koukai Publishing (JKS) publications and documents and JKS Store database, they are provided "as is" without warranty of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability, accuracy, fitness for a particular purpose, or non-infringement. Any reliance on the information provided herein is solely at the user's discretion and risk and neither JKS nor any third party source would be liable for the contents of the JKS publications and documents and JKS Store database. In certain circumstances, works which have been sourced from a third party and incorporated into the JKS publications and documents and JKS Store database and any interpretations and commentaries relating thereto, may not be considered to be official versions of such works. JKS are committed to use utmost efforts to include accurate, actualized and reliably translated information, but JKS make no warranties or representations as to its accuracy. The Japanese Government does not provide authorized (officially sanctioned) translations of its documents. In case of legal dispute, the original texts in Japanese will prevail. Neither JKS, nor any party involved in creating, producing or delivering JKS publications and documents shall be liable for any direct, incidental, consequential, indirect or punitive damages arising out of access to, use of or inability to use publications and documents, or any errors or omissions in the content thereof. Jouhou Koukai Services LLC and its business Jouhou Koukai Publishing provide information and intelligence on the Japanese pharmaceutical market in the fields of medicine, pharmaceuticals, patents, licensing, copyrights and data protection, business and corporate development, information technology, including e-health, and medical communication, however, this information does not constitute for nor can it be used as such for a substitute of medical, legal or investment advice. Worldwide Copyright ゥ 2001-2005 by JKS LLC Reproduction in whole or part without permission is forbidden. www.jouhoukoukai.com 1 的mmediate・refers to a short - from the point of view of the authorities, period to organize a briefing after important ICH meetings ・in this particular case of about 5 weeks following the Brussels meeting. 2 12th ICH Meeting held on June 21, 2005 in Tokyo (for full report see in the JKS Document Store at http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=CTGY&Category_Code=JMI2 3 The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ・along the translation in Japanese of the full name of the Conference, 的CH・in English is commonly used. 4 ICH Topic ・Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability. 5 For a detailed description of the Second Supplement to JP XIV see in the report 鼎urrent Issues in QA of Medicinal Products・ available in the JKS Document Store at http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=PROD&Product_Code=JM_I_015&Category_Code=JMI 6 ICH Topic ・Q9: Quality Risk Management. 7 More about the Pharmacovigilance practice in Japan could be found in the report of the 20th and 21st New Drug Evaluation Division Information Meeting available online respectively at (http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=PROD&Product_Code=JM_I_009&Category_Code=JMI) and (http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=PROD&Product_Code=JM_I_017&Category_Code=JMI) 8 PAB/SD Notification No. 160 dated October 2, 1989 entitled 敵uidelines as to the Distribution, etc. of Emergency Safety Information・?? ?? ?? ?? 13th ICH Immediate Briefing December 2005 JM_I_027 - 3 -