As discussed in chapter III, different situations may require different approaches. These are discussed below.

1. Data Usable for Building the New Computerized System

For the purpose of this guide, usable data means MA data that reflects the reality of the drug items actually being marketed, and that have the sufficient consistency and completeness to permit their use as the basis on which the new computerized system is built. Therefore, a DRA has usable data if its files physically contain all the pieces of information that are required for entering into the new system, and if these pieces of information actually reflect the situation of the marketed drugs.

Convert old data

If the DRA is changing from a previous computer system to a new one and the data in the existing one are usable, it may be possible to convert that data for use in the new system, without having to re-enter all of the information. This conversion is best done in close consultation with a technical advisor on the new software programme, who will be able to assist in determining if the data can be converted, and how. Manipulating data for direct entry into a programme’s databases, rather than entering it through the programme’s data entry screens, should only be done by those very skilled in both database management and the new software programme’s structure.

In most cases, partial conversion of existing computerized data is possible. Examples of scenarios with data that may be difficult to convert are:

• If the previous system did not have a facility to check consistency of substance names and track synonyms, direct conversion of data would not solve the problem of inconsistency of substance names. Therefore a specific activity should be started to progressively “clean” the existing database.

• If the previous system did not store substance names as database fields, but as text fields, it will be difficult to import the data into database fields.

Data Conversion Steps

Stop new applications, enter backlog, reopen

This approach requires notifying applicants that no new applications for MAs or variations will be accepted between certain dates, i.e., the “ban period.” During the period when no applications are coming in, DRA staff - with additional temporary staff if possible - can concentrate on entering all backlog information. When this is completed and data quality has been reviewed, applications will be accepted again and entered in the system as they are received.

The ban period must be as short as possible. In addition, criteria should be set to allow applications for vital drugs with no available alternative to be received and processed even during the ban period. The main advantage of a ban period is that staff can concentrate on preparing a clean database before new information is accepted. The main risks are that a) it may be “politically” difficult to stop receiving applications and b) existing information on file may be incomplete and the expected clean database may not be achieved in the time frame anticipated.

Enter backlog gradually while accepting new applications

If it is not possible to stop receiving applications as outlined above, the only other choice is to enter the backlog gradually while new applications are being received. In countries where the validity of marketing authorizations is fixed by law or regulations to a given number of years, the simplest approach is:

1. Start to enter information with the most recently approved drugs and proceed backwards. In this way, older authorizations for which no renewal is sought will expire before they are entered into the computer system and will never be recorded.

2. Marketing authorizations regarding registered products for which applications are received while entering the back log are recorded when a decision is made, regardless of their validity date. In this way, the computer system will issue the relevant certificate (renewal or variation). In fact, in these cases one assumes that the fact that an application is submitted implies that the drug is actually being marketed and that the MA holder is interested in keeping it on the market.

3. Applications for new marketing authorizations are entered as they arrive.

If sufficient staff are available, separate staff and/or separate working hours, could be dedicated to entering the backlog information according to the “reverse order” method and to the authorizations triggered by incoming applications.

Countries where marketing authorizations are valid indefinitely, and that cannot change this regulation while reviewing legislation and regulations, need to decide whether they must enter information on all MAs or only on those of products actually marketed. Possible approaches are shown below.

• Enter same data on all MAs. Choose any work programme and start data entry.

• Enter data only on MAs of products actually marketed. If no reliable system to identify products actually marketed is available, start entering data only for applications for new MAs and MAs for which certificate, renewal or variation applications are received.

• Enter full data only on MAs of products actually marketed and minimum data on MAs of products not actually marketed. Give priority to entering data only for applications for new MAs and MAs for which certificate, renewal or variation applications are received. Whenever time permits, carry out data entry of basic information starting from MAs that were issued over 10 years ago and go backwards from then.

2. Unusable data

Unusable data are those that are so incomplete, outdated, inaccurate, or unreliable that they cannot safely be used in the new computer system. There is no specific method to identify whether data in a DRA is unusable. DRA staff should know whether data on MAs accurately reflect the drug items actually being marketed, and whether those data are sufficiently consistent and complete to permit their use as the basis on which the new computerized system is built. If DRA staff are unable to determine this, then data is not usable. If existing data cannot be used, there are two options, described below, for creating a database for a computer-assisted system.

Inventory market situation

An inventory of the market situation is necessary in all cases where no reliable or up to date information is available about all medicinal products actually being marketed. Such an inventory requires that companies with products on the market who are willing to continue marketing them make this known in writing to the regulatory authority. This notification will entitle companies to a temporary marketing authorization. Products for which no notification has been given by a certain date will no longer be allowed on the market, and companies responsible for their importation or sale will be penalized (e.g., seizure, plus cost of destroying them, plus fine).

The DRA’s request for notification on existing products may be simple, i.e., require only minimum information to be provided, if it is reasonably certain that a formal assessment for registration (see below) will eventually be conducted. The minimum data to be collected in a notification are:

• Name of the medicinal product (either generic or brand name)

• Name of active ingredient(s) using the INN (International Nonproprietary Name), if available

• Dosage form, strength and route of administration

• Purpose of use (although this may not always be an approved indication)

• Manufacturer, name and full address

• Manufacturing country

• Package sizes and prices

If a formal assessment is not going to be made, it may be appropriate to introduce additional elements in the notification request, requiring that other documents are submitted with the notification in order to make it valid. In addition to the minimum data listed above, the notification form should include at least the following details:

• Main therapeutic group
• Importing agent, name and full address (if applicable)
• Complete composition with active and inactive ingredient(s) and their quantities
• Therapeutic indications
• Copy of all labelling, including any package insert
• WHO-type product certificate from the country of origin

If the manufacturer or importer (distributor) does not provide the required information, the sale of the product after a fixed date may be forbidden.

Before, or immediately after, the end date for companies to submit a notification, the regulatory authority should publish criteria for issuing regular marketing authorizations and plan, on the basis of the estimated workload entailed, a more formal assessment of the drug items that have been given temporary marketing authorization. At least three different approaches are possible:

• Start, without defining a precise schedule, asking companies (all together, in alphabetical order, or otherwise) to submit the required documentation as when applying for an MA for the first time. This approach does not allow the DRA to determine how long it will take to assess all drugs with temporary MAs, and will require extending their temporary validity indefinitely. This is the approach taken by most industrialized countries.

• Establish a predefined schedule for assessment of temporary MAs and endeavour to meet deadlines.

• Establish priorities according to any preferred criteria (e.g., fixed-dose combination drugs, imported drugs, therapeutic classes, etc.) and start requesting submission of documentation on the basis of these.

Resubmit all applications, build database gradually

This approach is similar to that of carrying out an inventory of the market situation, but with a major difference. Companies are not asked simply to notify and submit minimum information on the products they are already marketing and wish to continue marketing, they are asked to submit a full application for marketing authorization based on published requirements and standards. This means that the DRA should be prepared to receive and process large amounts of documentation.

Compared to the notification approach, this has the advantage of establishing a baseline documentation against which all future routine controls and applications for variations and renewals can be checked. The disadvantage is that the DRA may be so overwhelmed by large amounts of documentation that it cannot even classify it properly, or verify whether it is accurate and complete. As in the case of the market inventory, products for which documentation is received are granted a provisional marketing authorization, which will be valid until technical assessment of the submitted documentation is done.