How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002: III. PREPARING FOR COMPUTER-ASSISTED DRUG REGISTRATION

How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002
(1998; 74 pages)

Índice de contenido

	ACKNOWLEDGEMENTS
	I. INTRODUCTION
		A. Background
		B. Purpose of Guide
		C. Benefits of Computer-Assisted Drug Registration
		D. Key Concepts
		E. Summary of Implementation Process Steps
	II. PRE-REQUISITES FOR COMPUTER-ASSISTED DRUG REGISTRATION
		A. Legislation and Regulations
		B. Human Resources
		C. Adequate Financing Mechanisms
		D. Hardware and Software
	III. PREPARING FOR COMPUTER-ASSISTED DRUG REGISTRATION
		A. Planning the Process
		B. Review and Update Procedures
		C. Review and Update Forms and Certificates
	IV. COMPUTERIZING DRUG REGISTRATION
		A. Data to Be Computerized
		B. Preparing Data
		C. Options for Entering Data into the System
		D. Using the Computer in the Drug Registration Process
		E. Train Staff
		F. Ensure Computer System Support
	V. MAINTAINING A COMPUTER-ASSISTED DRUG REGISTRATION SYSTEM
		A. Written Procedures
		B. Checking Quality of Data
		C. Retaining Staff
		D. Political Support
		E. Maximize Existing Resources
	ANNEXES
		Annex 1: List of Acronyms
		Annex 2: The Drug Registration Process
		Annex 3: Specific Aspects of Drug Registration Legislation
		Annex 4: Minimum Requirements for a Drug Regulatory Authority
		Annex 5: Glossary
		Annex 6: Sample Data Entry Form
		Annex 7: Further Reading

III. PREPARING FOR COMPUTER-ASSISTED DRUG REGISTRATION

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.