Pharmaceutical affairs law

The data requirements for the registration of new drugs were defined in the Pharmaceutical Affairs Law and its Enforcement Regulations. Practical guidelines were issued in PMSB Director General Notification No. 481 dated... 

NDA Application Form (format based on Pharmaceutical Affairs Law Enforcement Regulations)... 

Pharmaceutical Affairs Law prohibits advertisement of non-approved drugs, that is, clinical study drugs. But if the study drug is not identified, the sponsor can advertise the clinical trial itself in order to recruit patients. 

In Japan, the principal legal regulations dealing with feed additives and veterinary drugs is the Pharmaceutical Affairs Law established in 1960. Table 11.10 summarizes the compounds currently regulated as medicinal or feed additives by the Pharmaceutical Affairs Law and the Law Concerning Safety Assurance and Quality Improvement of Feed in Japan (74). 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

The Chemical Substances Control Law regulates chemical substances produced by chemical reaction excluding natural products. However, articles and substances regulated by other laws, such as the Food Sanitation Law in Japan and the Pharmaceutical Affairs Law, and exclusively used for the purposes covered by such laws, together with substances used for research and development, are also exempt from the Law. 

Under the Industrial Safety and Health Law, unlike the Chemical Substances Control Law, all chemical substances including a chemical substance regulated by other laws, such as the Food Sanitation Law in lapan and the Pharmaceutical Affairs Law, and used exclusively for the purpose permitted by such laws must be notified. Notification of a substance is accepted if it shows a negative result for the test and the notification document is complete. On acceptance, the substance can be manufactured and / or imported. If the substance shows a positive result for the test, the competent authority requires that additional tests be performed, such as a chromosomal aberration test, and the provision to workers who handle the substance with the information on safety, handling methods and emergency measures for the substance described in a Material Safety Data Sheet (MSDS). 

Outside the United States, the Organization for Economic Cooperation and Development (OECD) publishes GLPs that have been adopted by its members and the European Union. These GLPs apply to the testing of chemicals to obtain information about their properties and/or their safety with respect to human health and the environment. The Japanese Ministry of Health and Welfare (MHW) has also published GLPs that apply to non-clinical laboratory safety studies that support applications to manufacture or import drugs or applications to re-examine new drugs in accordance with the country s Pharmaceutical Affairs Law. ... 

OTC sales will take place in convenience stores and supermarkets cis well as pharmacies. This is due to be implemented as of July 1, 1999 following cin amendment of the Pharmaceutical Affairs Law in 1998. Late 1998 classification standards of Simple Drugs are to be established ... 

In Japan, the Pharmaceutical Affairs Law 1960, as amended, and the Standards for Fair Advertising Practices concerning Medicinal Products define the standards for marketing practices with respect to medicinal products. The Fair Competition Rules were established by the Japan Fair Trade Commission, in accordance with the Law for Preventing Unjustifiable Extra or Unexpected Benefit and Misleading Representation. 

Cases of a serious offence against the Pharmaceutical Affairs Law and the Fair Competition Rules are subject to criminal sanction (i.e. up to 2 years in jail and/or a fine of up to 1 million yen). Such serious sanctions against a company, together with a public announcement, would place the company at a considerable disadvantage with respect to its business in Japan. 

Member companies shall fully realise that brochures, advertisements in medical journals, internet web pages for the medical profession, audiovisual materials such as slides and video tape-recording, and other promotional materials are important media in dissemination of drug information, and they must produce and use those materials in compliance with the Pharmaceutical Affairs Law and relevant selfregulations. The statements contained in these materials must be correct, fair and objective, based on scientific data. 

General Affairs Division. This division coordinates all activities of the PFSB, enforces the Pharmaceutical Affairs Law (PAL), manages questions related to the PAFSC, and provides guidance and supervision to the PMDA. Two offices attached to the Planning Division are as follows ... 

Japanese pharmaceutical administration has a long story it started during the reign of Emperor Meiji, a period during which Japan reopened its frontiers to Western countries. The first law, enacted in 1874, dealt with pharmaceutical sales and handling, but it was limited to three areas (Tokyo, Osaka and Kyoto). Fifteen years later, the law covered the whole country and was merged with another law,-the Patent Medicine Law, in 1925 it was then renamed the Pharmaceutical Affairs Law in 1943. 

Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations. 1996. Yakugyo Jiho Tokyo. 

The Japan Federation of Medical Devices Associations. 2004. The Pharmaceutical Affairs Law - New Regulations Effective in 2005. Yakuji Nippo Tokyo. 

Table 38.1 Subtitles that must appear in Japanese drug labeling, and the order in which they appear (after Article 52, Item 1 of the Pharmaceutical Affairs Law)...

An October 1993 amendment of the Pharmaceutical Affairs Law (Article 14-4) made provision for priority review for orphan drugs, orphan medical devices and innovative drugs or medical devices that have been authorised to be highly necessary from a medical standpoint . The new ordinance sets out standards to define both orphan drugs and the criteria by which innovative drugs will be decided for priority review. 

Based on Step 4 of the ICH Good Clinical Practice (GCP) guideline of May 1996, the Japanese Ministry of Health and Welfare (MHW) prepared an amendment to the previous GCP guideline and on 27 March 1997 this was issued as MHW Ordinance of the Standards for Good Clinical Practice . This new GCP became effective as of 1 April 1997 with some moratoria (preparation of standard operating procedures (SOP) at medical institutes, source data verification, etc.), and full implementation was from 1 April 1998. Unlike the previous GCP guidelines, the new GCP is based on the revised Pharmaceutical Affairs Law of June 1996, which requires... 

Recent changes in the operation of the Pharmaceutical Affairs Law and Medical Practice Law provided options for patient recruitment for both sponsors and hospitals. Pharmaceutical Affairs Law prohibits the... 

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