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GOOD CLINICAL PRACTICE IN JAPAN: CURRENT STATUS AND FUTURE PERSPECTIVES

National Institute of Health Sciences, Tokyo, Japan Although the International Conference on Harmonization (ICH)-based Good Clinical

Practice (GCP) regulation was introduced in Japan in 1997–1998, it is not easy to adopt the new standard because of unique medical and social practices in Japan. Difficulty in

obtaining informed consent, a shortage of clinical research coordinators, and a lack ofsocial awareness are the major obstacles. To retain clinical research within the country,

substantial measures should be taken by both regulators and sponsors.

STARTING APRIL 1, 1998, the Japanese fare (MHW) had been taking necessary mea- sures such as requesting sponsors to provideGCP regulations were totally revised to meet

the ICH standards based on ICH topic E6 notification of clinical trial plans beforehand through its administrative guidance.which reached Step 4 in May 1996. Though

it is still a bit early to evaluate the effect of The PAL began regulating clinical trials in the 1979 PAL revision which became ef-the amendment, this brief report describes

the current situation of Japanese clinical tri- fective in 1980. The newly introduced scheme included the sponsor’s obligation toals under the new GCP regulations and pro-

vides future perspectives. submit a clinical trial plan, and the Minister’s authority to instruct sponsors to modify the trials to avoid possible health hazards.

HISTORY OF JAPANESE GCP

After lengthy formulation and a two-year public consultation period, Japan’s first GCPIn Japan, the drug approval process is regu-

lated under the Pharmaceutical Affairs Law was enforced in 1990 and became a funda- mental rule for clinical trials. Compared with(PAL). Until 1980, however, this law did not

have an explicit clause regulating clinical tri- GCP in the United States, Europe, and the World Health Organization, which were pri-als, although the Ministry of Health and Wel-

marily promulgated in the late 1980s, Japa-nese GCP possessed certain characteristics

reflecting the unique environment of thePresented at the DIA Workshop “Recent Developments

in Clinical Trials in the Asia Pacific Region,” October country’s medical practice. For example, in-

2–3, 1998, Taipei, Taiwan, Republic of China.

vestigators were allowed to enroll a subject

Reprint address: Hajime Inoue, MD, Pharmaceuti-

on his/her oral consent, although written con-

cal and Medical Devices Evaluation Center, National

sent was recommended as preferable. An-

Institute of Health Sciences, 3–8–21–10F, Toranomon,

other example is that Japan’s GCP did not

Minato-ktoring/auditing performed at the trial sites cially in regard to medical practice. Doctors are used to making decisions, and even somewith access to original medical records and

related documents. Thus, sponsors could not patients have a tendency to feel more com- fortable letting doctors do whatever theydirectly access source documents to assure

their quality. think is right instead of being informed fully and asked to make a decision themselves. InThe 1997 revision of Japan’s GCP was

prompted by two factors: addition, Japanese people are sensitive about possible side effects of drugs and hence, once all of the major undesirable possibilities have1. There was serious domestic concern on certain aspects of clinical trials. This revi- been properly explained in a written form, which is not usual in daily medical practicesion was partly pushed by the severe ad-verse drug reaction incident in 1993 by in Japan, they have a tendency to refrain fromenrollment even though the risk is small.an antiviral agent which caused 15 deathsduring its clinical trial and postmarketing On the one hand, Japanese researchersfully recognize the importance of gettingperiod before its recall, and 2. The agreement on the internationally har- proper informed consent in clinical trialseven though it is not common in daily medi-monized guideline of ICH-GCP. In May

1996, the ICH-GCP guideline reached cal practice, but on the other hand, it contra- dicts traditional doctor-patient relationshipsStep 4 of the ICH process, meaning the

regulatory authorities of each participating which are deep seated in the Japanese cul- ture. For better or worse, introduction of theregion (ie, European Union, Japan, and the United States) are expected to incorporate new GCP with proper informed consent will force Japan to change its medical practice asthe guideline into their domestic regula- tions. Thus, MHW was expected to amend a whole to the point where doctors are held accountable for their medical treatment andits GCP based on this guideline. patients are responsible for their own health.

Answer 1

Good clinical practice in Japan : Current status and future perspectives .

The international conference on harmonization was introduced in Japan in year 1997 - 1998 but it was not found to be easy to adopt a new standards because of unique medical record and social problems in Japan and to retain the clinical research within the company many measures are taken .As a starting in step 1 ,the Japan GCP regulation was fully revised inorder to meet the ICH standard based on topic E6 and reached its step 4 in may 1996 and this report describe new GCP regulation and future perspectives .

The Japan's first GCP was enforced in 1990 and it was become the fundamental rules for the clinical trials .The GCP in United States ,Europe and in World Health Organization which are then implement in the late 1980 because the Japanese GCP have some characteristics which shows the unique environment of the country's medical practice .for example the investigators are allowed to register based on one's oral consent but written consent are more preferred .another example include ; The japanese GCP doesn't have a section for concerning the sponsors monitoring or auditing thus ,the sponsors will not able to access documents to assess the quality .

In 1997 the Japan's GCP was revised and it include 2 factors ; *) This revision pushed gets pushed by the severe adverse drug reaction in 1993 because of serious domestic concerns on clinical trials .* ) Introduction of informed consent in clinical trials even though it is not common in guidelines of ICH- GCP

Due to the introduction of new GCP ,forced the Japan to change the medical practices which makes the doctors to accountable for their treatment and make patient responsible for health .