Column

Global Newsletter

Volume of importing medical devices and updated medical device regulations in Thailand

According to the Plastic Institute of Thailand, Thailand's medical device imports grew by about 23% in the 2Q of 2021. And is expected to average 6.5% per year due to the aging of the population, rising demand for healthcare.

• Thailand
• Medical Equipment
• Laws

Regenerative Medicine Column

ISSCR Special Edition:Regenerative Medicine and list of Regenerative Medicine Products Approved in Japan

This article is a special edition of the Regenerative Medicine Column distributed at the ISSCR Tokyo International Symposium 2021 held in October 2021. It introduces Remedy's Approach to Regenerative Medicine and list of Regenerative Medicine Products Approved in Japan.

• Regenerative Medicine Product
• Laws
• Product

Global Newsletter

Orphan Drugs and Rare Diseases in Asia.

Development of orphan drugs is often difficult to get off the ground due to the cost of manufacturing the drugs and the risk of sales. However, in Asia, many patients seeking treatment, even for very rare diseases.

• Market
• Laws
• Approval

Global Newsletter

Differences in BE studies between Taiwan and Japan

Bioequivalence (BE) studies are performed to assess the in vivo biological equivalence between two pharmaceutical products. The regulations for BE studies in foreign countries can vary significantly in comparison to Japan.

• Taiwan
• Laws
• Approval

Global Newsletter

Swift Market Authorization into Australia with COR-based Approach

In Australia, where the market for medical products is expanding, do you know that a regulatory scheme has been introduced to shorten the approval process for drugs that have already been submitted for marketing approval in other countries?

• Australia
• Laws
• Approval

Regenerative Medicine Column

Conditions for use of regenerative medicine products and specified medical care coverage system for clinical trials

In this article, we will explain the conditions under which regenerative medicine can be applied to treatment, as well as the system of uninsured concomitant therapy expenses for clinical trials.

• Clinical Trials
• Insurance System
• Laws

Regenerative Medicine Column

Regenerative Medicine-Related Laws. - Vol.3 -

Gene therapies are categorized as regenerative medicine under Japan’s Pharmaceutical and Medical Device Act.

• Laws

Regenerative Medicine Column

Regenerative Medicine-Related Laws. - Vol.2 -

The Act on Ensuring the Safety of Regenerative Medicine, etc. enacted in 2013 has placed a net of pre-regulation over free medical treatment using cell processing products, which was previously unregulated as part of the scope of doctors' discretionary authority.

• Laws
• Treatment and Technology

Regenerative Medicine Column

Regenerative Medicine-Related Laws. - Vol.1 -

In the Japan Revitalization Strategy announced in 2013, the government focused on regenerative medicine-related laws.

• Laws
• Regenerative Medicine Product