Some DRAs choose to rely on decisions made by DRAs in other countries, while others use scientific reports prepared by other DRAs.

If the decision of another DRA is adopted, it is nevertheless essential for certain minimum information to be available. This is further discussed below (see sections “Initial decisions on options for premarket evaluation” and “Evaluation of data on quality” under Part IV).

The use of scientific reports prepared by experts in other national authorities does not necessarily mean automatically adopting the decisions made by other authorities. When a well prepared scientific report is available, a small DRA may be in a position to make its own decision in the light of local circumstances. With experience and a readiness to listen to feedback from local health workers, the utility of local decisions will improve.

Some agencies share in the preparation of reports while maintaining sovereignty over decision-making. The Pharmaceutical Evaluation Report (PER) scheme, the European Union and the Nordic Council on Medicines (Denmark, Finland, Iceland, Norway, Sweden) are examples. This is in no way a loss of sovereignty, but a sharing of expert resources to the advantage of all parties.

WHO encourages regional and international collaboration among DRAs to promote the harmonization of requirements and practices, and to strengthen professional competence. The International Conference of Drug Regulatory Authorities (ICDRA), which was founded for this purpose in 1979, meets biennually in different regions.

It is recommended that DRAs establish communication links with other agencies in order, among other activities, to share scientific reports on new products. Links that include one or more well resourced national authorities are of benefit to less well resourced authorities. As a part of a broader package, such linkages can be of benefit to all participants, for example to take advantage of the larger population base to generate statistics on adverse reactions, drug utilization, and so forth.

However, when sharing scientific reports, it is important to ensure that the data received by both agencies are the same; a report on a different data set will only cause confusion. It is also usual to seek the written agreement of the applicant company before using a report from another DRA. However, this may not be mandatory in all countries, depending on legislation concerning confidentiality of data. If the applicant’s approval is not sought, it is nevertheless usual for it to be informed that a foreign report has been used. The usual sequence of events is:

X Make provisional arrangements with the other DRA (e.g. arrange the timing and check whether an evaluation is already available);

X Seek the company’s agreement and a statement confirming that the data are the same;

X Exchange the evaluation.

If a report from another DRA is either not relevant (e.g.it relates to a different formulation or different data), is incomplete, or is of a poor scientific standard, the receiving DRA is not obliged to use it and can generate its own report.

Even when a government intends that ultimately the DRA should prepare its own reports, evaluators cannot be expected immediately to acquire the expertise and experience needed; these must be built up over time. The short-term options therefore depend on the expertise and experience that are immediately available. These short-term arrangements should be agreed with government when the marketing authorization activities are still at the planning stage.