BTRA 642. Global Biotechnology Business

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snseru

Science

BTRA 642

University of Maryland Global Campus

BTRA

Question Description

I'm working on a biology exercise and need an explanation and answer to help me learn.

1) Mention 3 cultural/regional influences that may cause differences beetween the US and the Japan approval process (include references as needed) 

2) For a US pharmaceutical company, who submits the post marketing safety report of drugs for product commercialized in Japan? 

3) PMDA accept and review foreign clinical data of medical devices which are applied for Marketing approval in Japan True or False? 

4) What is the purpose of having a PMDA prior assessment consultation? 

5) What do you consider are the key factors for a regulatory professional to have a succesfull PMDA consultation meeting? 6) What do you think of policies in countries like Japan and China that mandate that a medical product seeking marketing approval have citizens of that country in clinical trials used to support the application? 

7) What do you think of the fact that the members of the various review committees that make up South Africa's MCC are not full-time employees? Does this have an impact on aspects of regulation other than waiting times?  

8) Lot release is a unique requirement. Do you think biologics should be subject to  lot release when drugs are not? Why or why not?

Explanation & Answer:
8 Questions
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Explanation & Answer

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BTRA 642. Global Biotechnology Business
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Question one
Cultural and regional influences may cause differences between the US and Japan's
approval process. Examples of cultural differences include language barriers, lack of skill in
discussions, and emphasis on punctuality (Harvey, n.d.). Usually, the Japanese are not comfortable
using English in communication, despite English being an essential subject in junior schools. The
issue affects an agreement in the drug approval process between the US drug manufacturers and
the Japanese working in the Medical Device Agency. The Japanese are not skilled in a Western
discussion style, making it difficult to explain the reasons for disagreeing. The culture affects drug
manufacturers' understanding of issues in the approval process and may lead to more time
consumption in the approval process. Emphasis on punctuality may cause increased time
consumption in the approval process for US drug manufacturers who arrive at the Japanese
Medical Device agency later than the agreed time.
Question two
Drug approval for local Japanese manufacturers differs from the foreign manufacturers.
Usually, the approval process for local manufacturers is easy as Japan’s PMD Act requires the
manufacturers to use MAH to act as the legal manufacturer in Japan. In contrast, the approval
process for foreign manufacturers is different. Unlike the local manufacturers who use MAH,
Japan’s Ministry of Labour and Welfare allows foreign manufacturers to register their medical
products under their names (Pacific Bridge Medical, n.d.). That means that a foreign drug
manufacturer can be a quasi-MAH in Japan. The foreign manufacturers must also appoint
Designated Marketing Authorization Holders to handle regulatory responsibility activities.
Therefore, for a US pharmaceutical company, the post-marketing safety report of drugs is
submitted by the designated Marketing Authorization Holder in Japan. The DMAH is an

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essential partner that performs all regulatory activities stated in the Japan QMS and GVP
Regulations.
Question three
PMDA indeed accepts and reviews foreign clin...

Gubznf574 (31962)
University of Virginia

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