Pharmaceutical Technologist - January 2008 - (Page 16)

Morioka and laws — such as requesting sponsors to correct mistakes and make additions to documents. The two main organizations that review clinical data are the Evaluation and Licensing Division of the Pharmaceutical and Food Safety Bureau, and the Pharmaceutical and Medical Devices Evaluation Centre of the National Institute of Health Sciences. The Pharmaceuticals and Medical Devices Agency checks submitted documents and these complicated organizations result in the ineffective review of submitted documents, as they are looked at from the point-of-view of separate policies. This results in inadequate advice and requests, which may delay clinical development, and increase costs. In 2003, the MHLW issued the ‘Three-Year Plan for National Clinical Trial Revitalization’ to improve clinical development, but it will be a long time before the plan’s efforts are realized. Proposals for revitalization To improve the clinical development market in Japan, it is essential to provide an effective clinical information system. For a newly approved drug, detailed information regarding adverse reactions and efficacy must be disclosed publicly. This information is beneficial, not only to patients and physicians, but also to pharmaceutical competitors and generic companies, as they may be able to introduce new category drugs more rapidly, which will expand Japan’s drug market — which is good for patients. Reform of the Japanese drug review system is inevitable, especially Key points • Lack of involvement and help from Japanese physicians in clinical trials may delay drug development. • The review process of the Japanese authority for new drug approvals is slow and inefficient. • The Japanese MHLW proposed a ‘Three-Year Plan for National Clinical Trial Revitalization’ in 2003. • Several programmes to accelerate drug approval are underway. when it comes to clinical data obtained in foreign countries, as these should be seriously considered for approval of a new drug. Data indicate that 30 out of 105 new drugs under the regular review process, and 15 out of 39 new drugs under fast track review process, use foreign clinical data for approval.6 Among 15 Japanese-approved drugs, eight were approved based on foreign clinical data only — no domestic trials were conducted. Usually drugs developed outside of Japan need pharmacological clinical studies before being approved in Japan, but some drugs are approved without such pharmacological studies. This is because of urgent needs for new, effective drugs, and the delay of ordinal clinical development. Collaboration of international clinical trials and establishment of common clinical data systems are laid out in the agreement of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).7 Under this scheme, the share of international clinical data for new drug applications in Japan may increase, which would also increase potential drug approvals in the Japanese market. This scheme is more favourable for foreign pharmaceutical companies than domestic ones because it is still difficult, as well as cost and time consuming, for foreign pharmaceutical companies to conduct clinical trials in Japan, making it favourable for them to get approval without Japanese clinical trials. However, it also increases the possibility of Japanese pharmaceutical companies gaining approval for new drugs in foreign countries with fewer clinical trials, resulting in fewer costs than the current process. For this purpose, Japanese pharmaceutical companies must increase the quality of clinical data and prepare data packages applicable for foreign regulatory submission. However, it should also be noted that bridging clinical studies must be conducted because pharmacological differences between races could cause serious problems in patients. For example, Arava (leflunomide) was approved for use in Japan in 2003 by, essentially, the review of data that was obtained in foreign countries. Because Japanese people are sensitive to idiopathic interstitial pneumonias, the drug caused adverse reactions. All treatments with Arava are now under close observation and regularly reported to the government agency It is difficult to eliminate pharmacological kinetic and dynamic studies specific for evaluating racial difference of new drugs because of lack of experience of use. It is reasonable to skip such pharmacological studies in the case of urgent needs, such as anti-infectious drugs. PT References 1. The Ministry of Health, Labour and Welfare; Pharmaceutical Medicine Supports “Era for Life”, Abstracts of the Vision of the Drug Industry (2002). www.mhlw.go.jp 2. Pharmaceutical Policy Institute, Pharmaceutical Policy News,19(February), 2006. 3. Pharmaceutical Policy Institute, Pharmaceutical Policy News, 8(October), 2002. 4. Pharmaceutical Policy Institute, Research Paper No.8.2001, Duration and Cost of drug Development 5. Pharmaceutical Policy Institute, Research Paper No.830.2005, Clinical Development and Review Period of New Drugs in the Case of 2004 Approved Drugs. 6. Pharmaceutical Research Institute, Research News, 19(February), 2006. 7. The Pharmaceutical and Food Safety Bureau of the MHLW, ICH guidelines in drug order No. 739 (August), 1998. www.mhlw.go.jp Hajimu Morioka graduated from Kyoto University (Japan) in 1975. Shortly after, he began work at Ajinomoto Co., Inc., central research laboratories in Japan and in 1989 he was appointed manager of Ajinomoto USA, Inc. He currently works at the Ajinomoto Property Centre. 16 JANUARY 2008 PHARMACEUTICAL TECHNOLOGIST http://www.mhlw.go.jp http://www.mhlw.go.jp

Table of Contents for the Digital Edition of Pharmaceutical Technologist - January 2008

Pharmaceutical Technologist - January 2008
Contents
Editor's Comment
News
Morpheus
Market Watch
Lagging Japanese Drug R&D
Croatia’s Innovation
Integrating PAT with Biopharmaceutical Development and Manufacture
Q&A

Pharmaceutical Technologist - January 2008