Quality Management
To enhance the quality and efficiency of drug review
and consultation service, to effectively manage the
confidential information of our sponsors, and to comply with
the DOH-directed policy of implementing an electronic
operation system, CDE has undertaken to set up a quality
management and electronic office system of operation.
Quality Management
The Quality Management of CDE includes the
following elements:
- File management
To establish an e-operation and database management
system to control the document’s receiving, transfer,
sending and filing.
- Standardized operation
In order to ensure the consistency and effectiveness of
drug review, and quality of our consultation service,
CDE has set up standard operating procedures (SOP) for
different itemized activities, including the review
processes, consultation process, check list, and
reporting format etc.
- Knowledge management
This system aims to assist colleagues of CDE to assess
information effectively, to share valuable reviewing
experience and to enhance productivity and quality of
our services.
Elextronic Office System
With an aim to comply with the DOH-directed
policy to electronize the drug registration and reviewing
system, CDE has outlined the following strategies:
- Establishing an electronic information exchange
system, according to the timeline defined by the Bureau
of Pharmaceutical Affairs.
- Electronizing the operating procedure by setting up a
system platform in the Quality Management System of CDE.
- Electronizing the database management, materializing
the knowledge management of CDE.
- Strengthening the security of data management by
setting up a decentralizing and authorizing system in
the access of e-information. Setting up emergency
management procedure to increase the capabilities of
coping with crisis.