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Pharmaceutical Administration and Industry |
The Controller Committee |
Clinical Evaluation | |||
| 1943 | The Pharmaceutical Affairs Law was enacted. | ||||
| 1948 | Federation of Pharmaceutical Manufacturers' Association of Japan established. | ||||
| 1955 | Incidents of Death by Penicillin Shock | 1957 | The double blind trials were began to be carried out between GABA and rninor tranquilizers. | ||
| 1960 | The Pharmaceutical Affairs Law was revised. (It concerned drug efficacy.) | 1960 | Clinical Psycho-Pharmacological Research Group was organized to publish the rating scales such as CPRG, PNRS, etc. | ||
| 1962 | Thc Thalidomide Incidents occurred. In reaction to this, the U.S. Congress passed the Kefauver Harris Amendment which required patients' consent. | ||||
| 1963 | The licensing standards for new drug were made more strict. (Animal experiments became necessary to test possible adverse effects on human embryos.) The Central Pharmaceutical Affairs Council established the Special Division to meet with Drug Safety. | ||||
| 1964 | The Declaration of Helsinki (Adopted by the World Medical Association) | ||||
| 1965 | Cases of tampering with ampouled rnedicine for cold The Central Pharmaceutical Affairs Council's examination for new drug approval gradually required substantive data of drug efficacy obtained through double-blind comparative trials. | ||||
| 1967 | The Ministry of Health and Welfare enforced the basic principles for approval of drug manufacture. | ||||
| 1968 | Japan Pharmaceutical Manufacturers'Association was established. The Ministry of Health and Welfare tightened the regulations for the combined drugs for medical use. | ||||
| 1970 | Clinicgl use of Chinoform was prohibited. General production of pharmaceuticals exceeded 1 trillion yen. Concrete plans were established for safety of the drugs prevents toxic incidents and adverse effects of drugs on their chronic use. | 1970 | The Controllcr Comrnittee began his activities in August. The members participated individually to the Drug Research Group,while discussing the methods of the double blind tests. | 1970 | In Octorber,Plaza Co., Ltd. was established as a legislative annex of "the Controller Committee".The office was located in 3-53-17,Sendagaya, Shibuya-ku,Tokyo. |
| 1971 | The recommendation for re-examining drugs was issued by an informal Research Group concerning with drug efficacy problems.
The Ministry of Health and Welfare notified the enforcement of drug re-evaluation The period for report of adverse reaction of new developed drugs was extended for three years | 1972 | The Committee constructed comprehensive computer programs for drug evaluation.(On request to the IBM) | 1972 | On December 20. The Journal"Clinical Evaluation" was launched. |
| 1975 | The Declaration of Helsinki was amended.(Issued at Tokyo)
Incidents of muscular atrophy Chloroquine Incident Accident | 1973 | In August,the Committee held a forum to develop a new computer program.
The Committee quitted the IBM,due to a dispute on the problem of ownership and royalities of computer programs. | ||
| 1976 | GMP(Good Manufacturing Practice)was enforced. | 1974 | The Committee developed his own comprehensive computer system for drug efficacy evaluation
DEMOS computer(Den Den Kosha's plan) was introduced and began data processing. Standing for protection of the examine,the Committee educated the people concerned about the necessity andimportance of obtaining patients' consent. | 1977 | Plaza Co.,Ltd.was renamed to "Clinical Evaluation"Co.Limited., |
| 1979 | The partial amendment of Pharmaceutical Affairs Law was approved.
Guideline for the Anti-hypertensive Drugs | ||||
| 1982 | In consequence of scandals relating to the documents of application form for clinical trials,the administrative punishment disposition was carried out.
Guideline for the Anti-inflammatory analgestics | 1980 | The Committee translated and published the guidelines of FDA. | ||
| 1983 | In January,The Meeting of Specialist for Clinical Trials was held.
Mr.Hiroshi Kumagai as the chairman. In April,Good Laboratory Practice was enforced. In May,Subcommittee meetings of both Special Organization and Good Clinical Practice were held. The Ministry of Health and Welfare notified that the examination for drug manufacturing approval were made more strict. It required a signature of the person who had carried out the experiments. The Ministry of Health and Welfare admitted foreign manufacturers to make direct applications. Tampering of data and leakage of informations took place frequently. In October,the Ministry of Health and Wealfare notified the members of the Central Pharmaceutical Affairs Council of their responsibilities and the way to deal with the data. | 1982 | Dec.8,the Committee held a lecture meeting "The ploblems in relation to Approval of new drugs",inviting the problem from EDA and West Germany as the speakers.(At the Tokyo Fedaration of Economic Organization Hall)
The press focussed on the Committee concerning how to regain the objectivity and reliability of the applied data. | ||
| 1984 | The clinical trial period for Maruyama Vaccine was allowed to extend to three years. | 1983 | May 10,Asahi Shinbun focussed on the Committee in "Series on the front of medical therapy" | ||
| 1985 | The MInistry of Health and Welfare notified acceptability of the clinical trial data prepared outside of Japan.
In September,the meeting of Japan-U.S. Market Oriented,Sector-Selective Discussion on Drugs and Medical Devices was held. In December,the draft of Good Clinical Practice was prepared. Guideline for the Anti-Anginal Drugs was publidhed. Guideline for the Anti-hyper tensive Drugs. | 1984 | Sep.8,the Committee held a satellite symposium "The Recent Topics on Clinical Trials" which was supported by Japanese Society of Biometrics.(Held at the Forum) | ||
| 1987 | In April,Guideline for the Oral Contraceptives.
In Octorber,Guideline for the Cerebral Circulation and Metabolism Drugs. | 1986 | The Committtee began management of long term drug administration.
The Committee discussed the problem on revising his comprehensive computer program for Drug evaluation system. | ||
| 1988 | In January,Guideline for the Anti-Hyperlipidmic Drugs.
In March,Guideline for the Anti-anxiety Agents. In July,Guideline for the Hypnotic Drugs. In Octorber,Guideline for the Anti-Angina Agents. In November,GPMSP(Good Post-Marketing Surveillance Practice)was notified to the pharmaceutical industry. The general principles (draft) for clinical evaluation of the new drugs was prepared. | 1987 | The Committee held the satellite symposium "The Tendency of Clinical Trial"(Held at Tokyo Garden Palace) | ||
| 1989 | In September,the meeting for preparing the phase I guideline was held.
In Octorber,Director-General,Pharmaceutical Affairs Bureau notified GCP.(Enforced on Oct.1,1990) | 1988 | The Committee renewed data analysis system adding a new function applicable to multiplicity.
The Committee began discussion about post-marketing surveillance. | ||
| 1990 | In Octorber,GCP was enforced. | 1989 | The Committee translated and published "Clinical Trial" written by Stuart J.Pocock. The Committee began to prepare post-marketing surveillance control system. | ||
| 1991 | In February,Guideline for the Anti-Neoplastic Drugs.
In June,GPMSP was notified.(Enforced Apr.1,1993) | ||||
| 1992 | In March,Guideline concerned with statistical analysis for clinical trial was notified. | 1992 |
In February,the Committee relocate their office. The new address is;2-1-15,Hiroo,Shibuya-ku,Tokyo | ||