Column

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

Global Newsletter

Change in China’s Regulatory Affairs

In November 2018, the Chinese State Medical Insurance Administration officially announced a trial plan for centralized drug procurement, the so-called “4+7 Plan”. We will check out what this policy and other changes in China's changing pharmaceutical regulations have in store for foreign innovators.

• China
• Approval

Global Newsletter

Taiwan, A Favorable Choice for Clinical Trials

What is Taiwan's potential and ability to constantly improve its clinical trial standards and review its process to keep up with current trends?

• Taiwan
• Market
• Approval