In preparation for computerizing the drug registration system, it is essential to review and update the regulatory authority’s procedures. A list of written procedures that a DRA should have can be found in Chapter V.
Define processing steps to assess new drug product containing new chemical entities (NCE), new drug product (generic), renewal of MA, variation to MA, etc.
This is a crucial decision for most regulatory authorities. The use of a computerized system allows the authority to keep track of all applications, identify those that have been awaiting assessment decisions for a long time, and describe their status at any given time. Obviously, to achieve this users must enter the necessary information into the computer system. Since different types of applications require different types of assessment, it is necessary to carry out some preliminary work so that the types of assessment procedures and the steps each entails can be entered in the setup of the computer system.
Decide how applications are received, distributed for assessment, assessed, and how/when/by whom each action is entered into the computer (specifying what needs to be done by a technical professional)
The use of a computer system demands a systematic approach to organizing workloads and workflow. An example is described in the table below. Correspondence or certificates may be generated at any step.
Step |
Who Performs |
Data Entered in the Computer |
1. Receipt of applications |
This activity requires no technical judgement. Therefore data entry is not necessarily done by a technical professional. |
A new entry is created in the computer system. In the case of applications for new MAs, the new entry entails: application number, applicant name, drug name, dosage form, and primary container. In the case of renewal or variation applications, the new entry entails: application number and linkage to the existing MA data. |
2. Admission of applications to the assessment process |
A technical professional carries out a preliminary review of the application to identify possible flaws that would not justify its admission to the assessment process. |
The decision not to admit the application entails issuing a letter to the applicant indicating the reasons for such decision. |
3. Assignment of assessment procedures |
When applications are admitted, a technical professional assigns them to an assessment procedure according to the nature of the application. |
Data entry entails selecting the appropriate procedure and indicating the date on which documentation is sent to each assessment step. To ensure proper follow up, the same coordinating person/unit assigns applications for assessment and receives assessment reports. The coordinating person/unit may decide not to complete the assessment procedure if the results of any assessment step recommend rejection of the application. |
4. Assessment and preparation of assessment reports |
Technical professionals assess the applications. |
Technical elements describing the drug item under assessment (e.g., substance names, roles of manufacturers, etc.) and assessment reports are entered into the computer system. Assessors inform the coordination person/unit of the completion of their work with a summary conclusion and the date on which this was reached. |
5. Decision |
The coordinating person/unit submits a proposed decision to the decision-making body. |
The coordinator records the decision into the computer system. Data entry entails indicating the decision and its dates of submission and decision. In the case of new MAs it entails numbering the new MA and indicating validity dates. In the case of renewal of MA it entails entering a new expiry date. |
Procedures must also be defined for archiving and access to hard copies of submitted documentation after the assessment has been completed. Legislation may dictate how long the documentation must be kept, or establish how and when it can be destroyed. In general, it is only necessary to have access to the last five years’ records for routine reference.
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