Japan represents one of the largest pharmaceutical markets in the entire world, even though it has a challenging business environment because of its demographics. According to the latest official numbers made public by the Ministry of Health, Labor and Welfare, the local market for prescription and nonprescription pharmaceuticals reached USD 88 billion in 2015, increasing by 10.7% from 2014. In this article, our company formation consultants in Japan
explain different aspects related to opening a pharmaceutical company in Japan
Pharmaceutical laws and regulations in Japan
The pharmaceutical industry in Japan
is structured based on different laws and regulations, among which the main ones are:
• The Pharmaceutical and Medical Device Act;
• The Poisonous and Deleterious Substances Control Law;
• The Narcotics and Psychotropics Control Law;
• The Law Concerning the Establishment for Pharmaceuticals and Medical Devices Organization;
• The Law Concerning Securing Stable Supply of Blood Products;
• The Stimulants Control Law;
• The Cannabis Control Law;
• The Opium Law.
The application and management of these laws are being prepared by the government as ministerial ordinances and notices, like the Enforcement Ordinance and the Enforcement Regulations of the Pharmaceutical and Medical Device Act, as well as notifications made by the Director General of the Bureaus or the directors of the Divisions in charge in the Ministry of Health, Labor and Welfare.
Our experts in company formation in Japan
can offer more details related to these laws and regulations, as well as assistance in setting up a company in Japan
Pharmaceutical companies in Japan
A pharmaceutical company in Japan
acts as any other business entity
in the country, with the special mention that certain rules and regulations have to be complied with, according to the kind of pharmaceutical items it produces. The company will be subject to the consumption tax
Our company registration agents in Japan can assist you to open a Japanese pharmaceutical company.
In addition, pharmaceutical companies in Japan must obtain certain licenses related to the manufacturing of medicinal items:
• A manufacturing business license, which is a manufacturing business registration for producing medical devices. This license is needed in order to manufacture medicinal products. If a manufacturer of an imported item is situated outside of the country, an accreditation as a foreign manufacturer is needed;
• A marketing business license
: our company formation
representatives in Japan
can offer more details on this type of license.
In case you would like to know more about the Japan pharmaceutical
industry, or for help in opening a company
here, please contact
our friendly team of company registration
executives in Japan