Requests to add new API or NHP monographs to the OEL Fastrac+ catalog

While OEL Fastrac+ (OFP) has OEL/ADE monographs for over 2,400 active pharmaceutical ingredient (APIs) and natural health products (NHPs), OFP customers can submit requests to have additional API or NHP monographs added to the catalog by contacting their OFP account manager. However there are some limitations to these requests. These limitations are as follows:

• The API or NHP must be a currently marketed product that has been approved by a regulatory authority such as the United States Food and Drug Administration (FDA), Health Canada, or the European Medicines Agency (EMA).
• There cannot be any proprietary or confidential information used in the creation of the requested monograph.
• The requested API or NHP monographs must not be an intermediate or impurity compound.
• The requested API or NHP monograph must not be an early stage compound (i.e. discovery, Phase to Phase IIB).
• An in silico assessment is not required.

In general, as long as the API or NHP has either an approved package insert or EMA assessment, a monograph can be written.

Anticipated Turnaround Time

The typical turnaround time from the time of the request to the addition to the OFP catalog is approximately two weeks for a single monograph. If multiple additions are requested at the same time, longer turnaround times can be expected.