(1) PURPOSE OF THE LAW AND SYSTEM
The objective of this law is to regulate matters necessary for securing the quality, efficacy and safety of pharmaceuticals, quasi-drugs (Iyaku-bugaihin), cosmetics and medical devices, while taking necessary steps to promote research and development of pharmaceuticals and medical devices in high necessity, and thereby improve public better health and hygiene.
(2) OUTLINE OF THE LAW AND SYSTEM
The Pharmaceutical Affairs Law subjects pharmaceuticals, quasi-drugs, and medical devices to various approval and permit systems, such as licence for marketing authorization holder and manufacture, marketing approval, pharmacy establishment permits, and pharmaceuticals and medical devices selling business permits, to ensure efficacy and safety of the products (Articles 4, 12, 13, 14, 24 and 39). In addition, prohibition of extravagant advertisement (Article 66), on-the-spot inspections by a supervisory agency (Article 69), a duty to reports on adverse reaction and etc. (Article 77-4-2) apply to pharmaceuticals, quasi-drugs, and medical devices.
(3) CABINET ORDER AND MINISTERIAL ORDINANCES
Enforcement Order of the Pharmaceutical Affairs Law
Enforcement Regulations of the Pharmaceutical Affairs Law
Cabinet Order for Administration Fees Related to the Pharmaceutical Affairs Law
Ministerial Ordinance for Registraion of Certification Testing Organization as Provided in Article 12:1 of the Enforcement Regulations of the Pharmaceutical Affairs Law
Ministerial Ordinance for Registraion of Lecturers as Provided in Article 91:3(3) of the Enforcement Regulations of the Pharmaceutical Affairs Law
Cabinet Order of the Pharmaceutical Affairs and Food Sanitation Council
Regulations for Structure and Facilities for Pharmaceuticals, etc.
Ministerial Ordinance for Standards in Manufacturing of and Quality Control for Pharmaceuticals and Quasi-Drugs
Ministerial Ordinance for Standards in Manufacturing of and Quality Control for Medical Devices and Extracorpeal Diagnostic Pharmaceutical Agents
Regulations for the Control of Drugs, etc. for Animals
Ministerial Ordinance for Manufacturing and Quality Control for Veterinary Medial Devices
Ministerial Ordinance for Manufacturing and Quality Control for Veterinary Drugs
(4) OUTLINE OF THE REGULATION
Pharmaceuticals, quasi-drugs, cosmetics, and medical devices (including veterinary drugs, veterinary quasi-drugs and veterinary medical devices)
2) Outline of Specifications, Standards and Inspections, etc.
i. Content of the Regulation
(a) License for marketing authorization holder and manufacture
"Business of marketing" is a type of business which retail, rentalor hand-over of drugs, quasi-drugs, cosmetics or medical devices, whicha person herself/himself has manufactured etc. (including manufacturingentrusted to another person, but not including manufacturing entrustedfrom another person) or imported, and any person who has not obtainedfrom the Minister the license for marketing business shall not engagedin business to market drugs, quasi-drugs, cosmetics or medical devices. It is expected of the licensed marketing authorization holdersto enhance, strengthen, and make accountable the post-marketing safetyarrangements.
"License for import and marketing" has been incorporated into "License for marketing authorization holder" after the amendment of the Pharmaceutical Affairs Law in 2005.
Thus, importation of drugs quasi-drugs, cosmetics or medical devices as business is allowed if a licensed marketing authorization holder submits import declaration with necessary information, including name and address to Kanto-Shinetsu Regional Bureau of Health and Welfare or Kinki Regional Bureau of Health and Welfare prior to custom clearance.
"Manufacturing business" is a type of business which only carries out manufacturing (only deliveries to manufacturers or manufacture-retailers are allowed; direct sales and other distribution to wholesalers are prohibited), and is only allowed as business for those who have received permits for a manufacturing business from the Health, Labor and Welfare Minister. To note, those who are only partially responsible in the whole manufacturing process, such as for wrapping, labeling or storage, are also required to obtain permits.
As for manufacturers who wish to produce in foreign countries pharmaceuticals, etc. destined for Japan, they can receive certification from the Health, Labor and Welfare Minister, and such certification is a requirement for manufacturing and sales approval for pharmaceuticals of foreign production.
(b) Approval for manufacturing and sales
Those entities who wish to manufacture and sell pharmaceuticals, etc. are required to receive approval from the Health, Labor and Welfare Minister on a product-by-product basis.
The Minister also has the authority to issue a product-specific approval (special foreign approval) for pharmaceuticals, etc. exported to Japan, upon application from a foreign manufacturer. In such a case, manufacturing and selling in Japan can only be conducted by the selected manufacturer-seller which the foreign manufacturer applicant selected upon application.
(c) Conformity assessment, etc.
The Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices (the "GQP Ordinance") and the Ministerial Ordinance on Standards for Post-marketing Safety Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices (the "GVP Ordinance") serve as approval standards for manufacturing business and selling in term of quality assurance and post-marketing safety measures. The GQP Ordinance demands manufacturer-sellers to control and supervise the manufacturer to market pharmaceuticals, etc. whose quality is assured, and to establish systems necessary in the post-marketing phase to gather and analyze information on safety and to allow for measures when necessary. In addition, with regards to post-marketing investigation and testing methods for pharmaceuticals and medical devices, there are Standards for Post-marketing Studies and Surveys Performed by Manufacturers and Distributors (the "GPSP Standards").
As for tests required for application of approval for pharmaceuticals and medical devices, the Ministerial Ordinance on Standards for Practice of Nonclinical Studies on the Safety of Drugs (the "GLP Ordinance") and the Ministerial Ordinance on Standards for Practice of Clinical Trials (the "GCP Ordinance") are in place, each respecting standard methods for testing.
For cosmetics, the Cosmetics Standards (Ministry of Health, Labor and Welfare notification) is provided, and in it are regulations regarding prohibition and restrictions on maximal composition of specific ingredients defined on the negative list. Antiseptics, ultraviolet ray absorbents and tar coloring allowed are defined on the positive list.
Medical devices are now classified in three groups (general medical devices, controlled medical devices and highly advanced controlled medical devices) based on risks, since April, 2005. General medical devices have no requirements for manufacturing approval or for sales. Of the controlled medical devices, those designated by the Minister (designated controlled medical devices) are subject to certifications by third-party certification organizations registered to the Health, Labor and Welfare Minister, and notification is required upon sales. Manufacture of highly advanced controlled medical devices requires approval of H.L.W.Minister and theire sale requres permission.
Veterinary drugs, etc. are regulated by the Ministry of Agriculture, Forestry and Fishery, and are subject to regulations such as the GLP for Veterinary Drugs, the Standards for Animal Biological Products, and the Standards for Antibiotic Pharmaceuticals for Animals.
To note, in order to ensure safety of biological product, the regulations have been strengthened to include measures such as mandatory appointment of a qualified manager for the products.
ii. Certification System (Approval Examination System)
The basic procedure for the certification system is as follows.
Application procedure for approval of pharmaceuticals, except for certain pharmaceuticals, begins with submitting written application documents to Pharmaceuticals and Medical Devices Agency (PMDA).
When PMDA accepts the application for new pharmaceuticals, it checks the application documents for compliance. After compliance check (documentary) is carried out, detailed review by an expert team is performed to produce an "review report". Final examination regarding quality, efficacy and safety of pharmaceuticals will then be carried out based on this report in consultation with the Pharmaceutical Affairs and Food Sanitation Council, after which approval from the Minister is issued.
Quasi-drugs and medical devices are also subject to examination for quality and efficacy or safety by the PMDA.
Applications for manufacturing (and selling) or import procedures for veterinary drugs, veterinary quasi-drugs and veterinary medical devices are accepted by the Ministry of Agriculture, Forestry and Fisheries via the prefecture. After the examination, if the Ministry does not find any prohibiting factors, a written directive for the approval and license certificate is issued through the prefecture.
Standard review period for administrative procedures regarding the approval and licensing of veterinary drugs is also established.
(5) HIGHLIGHTS OF THE RECENT AMENDMENT OF REGULATIONS
The amendment of the Law in April, 2005 strengthened the post-marketing safety measures and also revised the approval and permit system. The amendments introduced the manufacturing-selling business (leaving drug substance manufacturers and expoters out of scope of the permit), and abolition, and integration into the manufacturing-selling business permit, of the importing business permit.
(6) REFERENCE INFORMATION
(Liaison Offices for Further Information)
Pharmaceuticals and Medical Safety Bureau, Ministry of Health,Labour and Welfare
Tel: 03-5253-1111 (Representative) http://www.mhlw.go.jp
Animal Products Safety Division, Food Safety and Consumer Affairs Bureau,
Ministry of Agriculture, Forestry and Fisheries
Tel: 03-3502-8206 http://www.maff.go.jp