The Steps For Review And Approval Are As Follows; Essay Sample

ICH

Question one
In Japan, Pharmaceuticals and Medical Devices Agency (PMDA) performs both reviews and approval.
Question two
The dossier package includes compliance with the GLP that stipulates the standards and procedures that must be followed in the development of a new drug. These include the safety issues and clinical trial procedures.

Question three

Given that there is no any application stage that consumes excess time, the application process takes between 1.9 to 2.5 months.

Question four

Application
Initial interview meeting
Questions on key issues
Expert review
Review report
PAFSC evaluation
Approval
Question five
The Japan territory does not have any unique issues in regards to drugs manufacturing and approval. It faces common challenges such as long review/approval process, quality issues, and sometimes bioethics issues.

Question six

Japan as a country has great potential in the the global pharmaceutical market. This is due to the fact that the country has set strict rules and regulations that must be adhered to when manufacturers are developing new drugs. The must adhere to drug safety regulations, clinical trial procedures and other rules that are set in the pharmaceutical affair law. Secondly, the country has an efficient review and approval system that ensure drug manufacturers have adhered to the required standards. PMDA ensures that new drugs meet the required international standards before they are approved. As a result, the Japanese drugs compete fairly with other high ranking countries in drug manufacturing such as US in the global pharmaceutical market.

Question seven

The territory is doing well in terms of review and approval process since it results to manufacturing of high standards drugs. However, it is necessary to shorten the period for review and approval in order to motivate the manufacturers as well as help in dealing with emergency cases drugs.