HSA-approved educational materials

Publication and distribution of educational materials

Following HSA’s approval of the educational materials, the registrant should submit the finalised artwork (i.e. version for local distribution) to HSA for publication on the HSA website when available (see How to submit).

The registrant must also ensure that all healthcare professionals who will be prescribing the product are provided with the latest copy of the HSA-approved physician educational materials. Copies of the latest approved patient medication guides and/or patient alert cards must also be made available to healthcare professionals for distribution to their patients who are supplied with the product.

Registrants are to keep the records of the distribution of these educational materials to the healthcare professionals and submit these records to HSA upon request. The distribution records must include the following information:

• Names of the healthcare institutions/clinics/pharmacies receiving the educational material(s)

• Date of distribution of the educational material(s)

HSA does not dictate the mode of distribution of the educational materials (i.e. hardcopy or softcopy), as long as the materials are disseminated in accordance with the product’s registration conditions. Companies who are planning to host educational materials on digital platforms are encouraged to notify HSA of their intention to implement an electronic RMP.

How to submit

Finalised artwork of HSA-approved educational materials should be submitted via:

• Therapeutic products

  • Approved within NDA or GDA application – Online form, or eCTD (Section 1.8.3.3 Finalised Artwork - Educational/RMP Materials, under the associated Submission Type (e.g. NDA, GDA), Sequence Type – Closing Information)

  • Administrative changes to approved materials – Online form, or eCTD (Section 1.8.3.3 Finalised Artwork - Educational/RMP Materials, Submission Type – PV-EDU/RMP Materials)

  • Approved safety or clinical revisions to existing materials – HSA will inform registrants of the method of submission

• CTGTP – SHARE (Fulfilment of Approval Condition)

Please indicate the purpose of the submission. For example, “Finalised artwork for [Product Name]”

Submission of revised educational materials

All post-approval revisions to the educational materials are to be submitted to HSA for approval or notification (see How to submit).

• For approval – Revisions affecting the clinical use and/or safety content of the educational materials must be reviewed and approved by HSA prior to distribution to the healthcare professionals.

• For notification – Revisions that do not affect the clinical use and/or safety content of the educational materials (e.g. editorial updates, artwork changes, version number or company logo changes, corrections of typographical errors, changes in address, and other administrative changes) do not require HSA’s approval and may be distributed following their submission to HSA.

Following HSA’s approval of the revised educational materials, the registrant should submit the finalised artwork to HSA when available. The revised materials will replace the existing version published on the HSA website.

How to Submit

Both draft and clean copies of the proposed revised educational materials should be submitted via: 

• Therapeutic products – Online form, or eCTD (Section 1.8.3.1 (Clean Proposed - Educational/RMP Materials) and 1.8.3.2 (Annotated - Educational/RMP Materials), Submission Type – PV-EDU/RMP Materials)

• CTGTP – SHARE (Fulfilment of Approval Condition)

Please indicate the purpose of the submission and application number (if applicable). For example, "Proposed revised PEM for [Product Name], Application no. XXXXXXXX"

Requests for discontinuation of existing educational materials

For educational materials that have been implemented locally for at least 5 years, the registrant can review the need for continuation of these educational materials and provide justifications to HSA should the registrant wish to propose discontinuing the existing materials (see How to submit).

The justifications should include:

• Summary status of safety concerns highlighted in the educational materials to support the discontinuation of the materials (e.g. changes in adverse event reporting rates or trends since implementation of the educational materials)

• New and/or emerging safety concerns associated with the product (if any) and the actions taken to manage these safety concerns over the past 5 years

• Whether educational materials were requested by HSA’s reference drug regulatory agencies, including an elaboration on the type of materials requested and whether these materials are still being implemented or have been discontinued

• Local annual sales data for the past 5 years

• Registrant’s proposed local education action plan for new and/or emerging safety concerns as well as those highlighted in the educational materials upon discontinuation of the materials

• Any other relevant information

How to Submit

Requests for discontinuation of HSA-approved materials should be submitted via:

• Therapeutic products – Online form

• CTGTP – SHARE (Fulfilment of Approval Condition)

Please indicate the purpose of the submission. For example, “Discontinuation of PEM for [Product Name]"