Analysis of various experts shows that the country market for drugs will continue to grow, and this demand is expected to increase as the country has a rapidly aging population, and demanding new medicines for associated conditions. Foreign pharmaceutical manufacturers can apply directly under their name for marketing approval if they perform the studies regarding quality, efficacy, and safety required for the drugs they intend to export to Japan and perform the necessary procedures. This is a system for a foreign company who does not have its corporation in Japan can utilize when marketing a drug in Japan. An individual company that intends to manufacture drug products, quasi-drugs, cosmetics, or medical devices overseas and import them into Japan is referred to as a foreign manufacturer and must acquire a Foreign Manufacturer Accreditation FMA from the Ministry of Health, Labour and Welfare to market such products in Japan. The government fee to obtain an FMA license is about , yen document review , and the standard processing period is about 5 months. Learn about clinical trial approval process in Japan. Click here to learn about the medical device approval process in Japan. A disease is considered to be rare if it occurs in less than 50, patients and Orphan drug designation can be applied for treating such rare diseases. Learn about rare disease drug development incentives provided by Japan regulatory. The approval of biosimilar products in Japan tends to reduce the amount of new information required and the approval timeline.
What documents and materials are required for Foreign Manufacturer Registration?
Who can apply for drug approval?
I was left mixed with Fullmetal Alchemist Brotherhood. On one hand, the story was epic and very well paced. Time for the usual brief summary. They are trying to find a way to restore their bodies back to their natural state; Al lost his entire body and Ed lost his leg and arm when they tried to bring their mother back from the grave.
It is a separate process from the product registration process, and is required for obtaining product registration approval. The audits are typically carried out via documentary inspections, although there have been a few on-site inspections in the past. Facilities that are responsible for manufacturing are assessed in order to confirm that the foreign manufacturer is able to participate in the product registration process. For medical devices, the following sites are required to be registered for each product:.
The steampunk world of Fullmetal Alchemist is primarily styled after the European Industrial Revolution. Set in a fictional universe in which alchemy is one of the advanced natural techniques revolved around scientific laws of equivalent exchange, the series follows the adventures of two alchemist brothers named Edward and Alphonse Elric , who are searching for the philosopher's stone to restore their bodies after a failed attempt to bring their mother back to life using alchemy. Yen Press also has the rights for the digital release of the volumes in North America due to the series being a Square Enix title. It has been adapted into two anime television series, two animated films—all animated by Bones studio—and light novels. Funimation dubbed the television series, films and video games. The series has generated original video animations , video games, supplementary books, a collectible card game , and a variety of action figures and other merchandise. A live action film based on the series was also released in