Published: 12 February 2016
Consultations
Changes to the data sheet process and the Guideline on the Regulation of Therapeutic Products in New Zealand. Part 10: Requirements for information for prescribers and consumers
Closing date: 31 March 2016
Executive Summary
Background
About the consultation
Invitation to comment
Consultation documents
Timetable
Content of submissions
How to respond
What will happen
Confidentiality
Enquiries
Executive Summary
Currently New Zealand data sheets generally place clinical trial and pharmacology data before prescribing information, such as the approved indications, contraindications, warnings and precautions.
In response to comments from medicine sponsors and healthcare professionals, Medsafe proposes to simplify the process for the format and the submission of data sheets.
Medsafe proposes a change to require a standard format for data sheets based on the European Summary of Product Characteristics (SPC) format, with minor adaptations to meet certain New Zealand legislative requirements and current regulatory policy. To this end, Medsafe proposes a timeline of 1 January 2017 for the format and layout changes to be implemented for all approved data sheets.
In addition, Medsafe is also seeking comments on the use of preferred terminology, electronic information delivery methods and the desirability of introducing "data sheets" for higher-risk medical devices, in order to inform the proposed new Therapeutic Products legislation.
Background
At present, there is a lot of inconsistency in New Zealand data sheets. The most sought after information is often not near the beginning of the document, increasing the time it takes to locate desired information. In addition, the order of the sections is not consistent between sponsors, further adding to the time taken to locate information.
The data sheet provides information for healthcare professionals on how to use the medicine safely and effectively. A standardised format will assist healthcare professionals to access information quickly as there will be uniformity in the format of the data sheet as well as in the information that is included in each section. Placing clinically relevant information at the start of the data sheet will also bring New Zealand data sheets in line with overseas regulators.
The Therapeutic Goods Administration consultation on "Mechanisms to maintain the currency of approved Product Information (PI) and Consumer Medicine Information (CMI)" held in 2013 was considered to be a joint agency project although the Australia New Zealand Therapeutic Products Agency is now not proceeding. Nevertheless, responses to that consultation were considered by Medsafe for New Zealand. Overall, submitters considered that standardisation to an international format was a good idea, as was placing critical and useful information at the beginning of data sheets.
Medsafe has reviewed the US FDA’s Product Information format and the European SPC format. Medsafe proposes that the European SPC format should be adopted, with minor adaptations to meet certain New Zealand legislative requirements.
Medsafe is of the view that current data sheets can easily be reformatted to the proposed format (a "shuffling" of the existing layout). To help with the reformatting, Medsafe has prepared a Data sheet template (Word document, 1 page) based on the SPC format.
Medsafe has also prepared guidance on preparing a data sheet in the accompanying Data sheet template explanatory guide (Word document, 25 pages). This explanatory guide is not critical for the reformatting of existing data sheets as proposed in this consultation. It is intended to assist in the preparation of new data sheets and has been included for information only.
There is no need for content changes to data sheets under this proposed process. If any content changes are to be made, these should be notified using the appropriate process (via either a Changed Medicine Notification or Self-Assessable Change Notification).
Medsafe emphasises that the proposed changes do not affect package inserts or CMI. These do not form part of Medsafe's current consultation.
About the consultation
Medsafe is consulting on these proposals and the following timetable for implementation:
New Medicine Applications
- New Medicine Applications where evaluation has not commenced – a data sheet in the proposed format should be submitted with the response to the initial Request For Information (RFI 1), or the Outcome of Evaluation letter.
- New Medicine Applications where evaluation has commenced or are in the final stages of assessment – a data sheet in the new format should be submitted in response to the Outcome of Evaluation letter.
- New Medicine Applications where evaluation has been completed and a recommendation for consent is made – data sheets should be submitted in the new format within 10 days of consent to distribute being notified in the New Zealand Gazette.
Changed Medicine Notifications
- Changed Medicine Notifications already submitted to Medsafe – data sheets do not have to be updated to the new format until 1 January 2017.
- Changed Medicine Notifications yet to be submitted to Medsafe – where the change(s) affects the data sheet, the data sheet should be submitted in the new format with the notification.
All other instances
- A Self-Assessable Change Notification for reformatting all existing data sheets to the new format should be submitted by 1 January 2017.
- Where there are other material changes instead of just a reformatting of the data sheet (such as content changes), the Changed Medicine Notification process should be followed.
As a consequence of the proposed adoption of the EU SPC format, the data sheet submission process (for submission, review and approval) has been simplified.
- Part 10 of the Guideline for the Regulation of Therapeutic Products in New Zealand has been revised and also forms part of this consultation.
- References to forms 10.1 and 10.2 are no longer necessary and have been removed.
- The data sheet submission, review and approval process now follows a chronological order.
- Information relating to the use of source documents is no longer relevant and has been removed. Sponsors are expected to use their own core data set or reference safety information relating to the applicable approved details for New Zealand when preparing their data sheets, or follow the market innovator or market leader.
The revisions made to Part 10 of the Guideline relate only to the section on data sheets. The part relating to the preparation of CMI is unchanged and is not included in the consultation.
Invitation to comment
Medsafe is seeking comments and input from interested parties on these proposals.
Consultation documents
Guideline on the Regulation of Therapeutic Products in New Zealand - Part 10: Requirements for information for prescribers and consumers (Edition 7.0) (Word document, 12 pages)
Data sheet template (pdf, 1 page)
Data sheet template (Word document, 1 page)
Data sheet
template explanatory guide (pdf, 25 pages)
Data sheet template
explanatory guide (Word document, 25 pages)
Declaration to accompany the
data sheet for publication (pdf, 1 page)
Declaration to accompany the data
sheet for publication (Word document, 1 page)
Timetable
Document released for consultation on 12 February 2016.
Interested parties should respond by close of business 31 March 2016.
Feedback will be released following consideration of submissions. (see
What will happen)
Content of submissions
Specific comments are sought on each section included in the guideline. In particular, Medsafe is seeking comments from interested parties on:
- the structure of the guideline
- whether the information is easily understood
- preferences for using the term ‘data sheet’ or its alternatives (such as Prescribing Information, Product information, Summary of Product Characteristics etc)
- the inclusion of summary of changes at the end of the data sheet to identify revised section headings and the month/year of the last issue
- the timeline for implementation of the new format
Medsafe is also consulting the industry on product information for higher-risk medical devices in this consultation.
Submissions may address any or all of the sections of the guideline.
How to respond
Please complete the Medsafe consultation submission template.
Medsafe Data sheet guideline consultation
submission template (pdf, 7 pages)
Medsafe Data sheet guideline consultation
submission template (Word document, 7 pages)
Submissions must include full personal or organisational contact details (including address, telephone number or email address)
Electronic submissions are preferred which should be emailed to medsafeadrquery@health.govt.nz including "Data sheet guideline" in the subject line of the email.
Alternatively, hard copy submissions may be posted to:
Clinical Risk Management
Medsafe
PO Box 5013
Wellington 6145
What will happen
Submissions will be reviewed by Medsafe and feedback on submissions will be provided on Medsafe's website. Input from submitters on the consultation draft will help inform the final shape, form or content of the data sheet guideline and the data sheet process.
Confidentiality
All submissions will be placed on the Medsafe website unless marked confidential. Any confidential material contained within your submission should be clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the submission coversheet. These reasons must meet Official Information Act criteria if the submission (or part thereof) is not to be displayed.
Official Information Act criteria: www.legislation.govt.nz/act/public/1982/0156/latest/DLM64785.html?search=qs_act_official+information+act_resel_25_h&p=3&sr=1.
For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the Medsafe website. In addition, a list of submitters will be published.
If you do not wish to be identified with your submission, or if you do not wish your submission to be associated with a party, you must specifically request this in the space provided on the submission coversheet.
Enquiries
Any questions relating to submissions should be directed to Medsafe by email to medsafeadrquery@health.govt.nz
