Drugs

PAL definition: Drugs

PAL Articles:

Paragraph 2. The term “drug” used in this law refers to the items specified as follow: (1) Items recognized in the Japanese Pharmacopoeia. (2) Items (excluding quasi-drugs) which are intended for use in the diagnosis, treatment or prevention of disease in humans or animals, and which are not equipment or instrument (including dental materials, medical or sanitary supplies; the same hereinafter). (3) Items (excluding quasi-drugs and cosmetics) which are intended to affect the structure or functions of the human or animal body, and which are not equipment or instrument.
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Paragraph 9. The term “biological product” used in this law refers to a drug, quasi-drug, cosmetic or medical device designated by the Minister of MHLW after seeking the opinion of Pharmaceutical Affairs and Food Sanitation Council (PAFSC), as manufactured (including repackaging; the same hereinafter) with materials derived from humans or other organisms (excluding plant) as the source materials, and requiring special caution from the viewpoint of the public health and hygiene.
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Paragraph 14. The term “orphan drug” used in this law refers to drugs specified pursuant to the provisions of Article 77-2, Paragraph 1, and the term “orphan medical device” used in this law refers to medicinal products specified pursuant to the provisions of the same paragraph.