KEY POINTS OF THIS CHAPTER
The planning process should begin with an assessment and overview of the current drug regulatory situation in the country, and an inventory of the market.
A DRA has usable data if its files physically contain all the pieces of information that are required to enter into the new system, and these data are accurate and reflect the current situation of the marketed drugs.
The time required to enter existing information into the system will depend on whether the current system is manual or computerized, and whether the existing data is usable or not.
In preparation for computerizing the drug registration system, it is essential to review and update the regulatory authority’s procedures.
It is very useful to review the forms and certificates used by the DRA, and update them as needed.
After the pre-requisites have been addressed with the involvement of other agencies and offices, preparation for computer-assisted drug registration enters a phase that is assumed to be fully under the drug regulatory authority’s control, and will primarily be its responsibility. A technical coordinator should be appointed, and will be responsible for overseeing the implementation process of computer-assisted drug registration. This person should ensure that progress proceeds according to plan.