Economic and Legal Frameworks for Non-Prescription Medicines 2004 studied by AESGP 2. MARKETING AUTHORISATION The Pharmaceutical Affairs Law (PAL), promulgated in 1960, as amended, is the nucleus of the control of pharmaceuticals in Japan, and its objectives are to ensure the safety, efficacy and quality of pharmaceuticals. Before the amendment of PAL, manufacturers or importers of medicines had to obtain "Approval" (a product approval) for the manufacture or import of each item as well as a "Licence" (a business licence) for the manufacture or import of the item approved. After the promulgation of the recent amendments, a simplified "marketing authorisation" is granted to the sponsor who is responsible for the quality, efficacy and safety of the product. Such a "marketing authorisation" is issued only for the final product and no longer for the intermediate or precursor product. Under the old scheme, the manufacturer had to show the full ability to manufacture and assure the quality of the products in his own facility to get the "Approval". The new system allows the sponsor not to have a production facility but to have a good system to monitor the quality and safety of the product. The new "Licence" system is being introduced as from 1 April 2005 to promulgate the above-mentioned amendment. The "Licence" for the sponsor of medicines is classified into two and for medical devices into three classes. In case the product is classified as a prescription-only medicine, the sponsor gets a "Class I Licence for Manufacturing and Marketing Pharmaceuticals"; in case the product is not classified as a prescription-only medicine, the sponsor would receive a "Class II Licence for Manufacturing and Marketing Pharmaceuticals". The "Licence" is based on official findings that the applicant satisfies the requirements under PAL with regard to personal requirements (namely, the applicant is not a legally incompetent person, is not addicted to narcotics, etc.) and with regard to conformity of the manufacturing facilities or equipment to the standard so that the medicine as approved can be duly manufactured or imported in accordance with the details and contents of the approval. A "Licence" shall be granted to each manufacturing plant or business place for import. Applications for Marketing Authorisation and/or Licence are filed either with the Minister of Health, Labour and Welfare or with the governor of the prefecture where the sponsor's premises is located depending on the nature of the application. As the working body for the Ministry of Health, Labour and Welfare, the independent administration authority called "Pharmaceuticals and Medical Devices Authority" (PMDA) receives the applications on behalf of the Minister. If herbal products are classified as medicinal products (or Kampo (Traditional Herbal) medicines), the same procedures apply. As mentioned in point 1 (Classification), homeopathic products are not a known concept in Japan and are not dealt with in a specific procedure. Vitamins/minerals classified as medicinal products follow the same procedures as other medicinal products. Registration by reference and abridged registration are not decreed in Japan. Based on a suggestion from the "Expert Committee for Streamlining Procedures to Approve and Examine OTC Medicines" formed within the Pharmaceutical and Food Safety Bureau of the MHLW, this Ministry issued a notice on 1 October 2003 to simplify and reduce the classes of medicines for registration purposes from six to four as follows:   Class (1): Drugs containing active ingredients that have been used neither in Rx nor in OTC (called New active ingredients). Class (2): Drugs containing active ingredients other than new active ingredients, which have not been used in already approved OTCs (called New OTC ingredients). Class (3): Drugs containing active ingredients used in already approved OTCs which fall into one of the following three categories (but Drugs (4-2) are excluded): (3-1): Drugs containing Newly combined ingredients (ingredients that have not been used in already approved OTCs in the therapeutic category in question) (3-2): Drugs having efficacy and indications or administration and dosage different from those of already approved OTCs in the therapeutic category in question (3-3): Drugs containing combinations of active ingredients different from those of already approved OTCs in the therapeutic category in question. Class (4): Other drugs (4-1): Drugs having applied for registration after completion of Post Marketing Surveillance on a drug in Classes 1, 2, or 3 containing only active ingredients that have pharmacological actions different from those in New active ingredients, New OTC ingredients or Newly combined ingredients. (4-2): Drugs conforming to the Approval Standards or drugs not falling into any one of Classes 1, 2, or 3 and which are not equivalent to (4-1).