Published: 8 May 2018

Consultations

Consultation on the revision of CMN Form B

Closing date: 31 May 2018

About the consultation

CMN Form B is used for Changed Medicine Notifications specific to biological or biotechnological products (e.g. vaccines, recombinant products, monoclonal antibodies and derivatives thereof, or a medicinal product derived from blood and plasma).

In this notification Medsafe is proposing a revised CMN Form B to introduce additional categories and to provide clarity to some of the category descriptions. The proposed changes to CMN Form B are aimed to improve the accurate selection of categories when sponsors are submitting Changed Medicine Notifications.

Medsafe emphasises that there is no change to the fee structure for the categories described in CMN Form B. However, the fees will be subject to the outcome of the current Medsafe consultation “Review of fees payable under the Medicine Regulations 1984”.

Proposal

The updates to CMN Form B include, but are not limited to, the changes proposed in the following table. The table summaries the most significant changes proposed to CMN Form B.

Proposed changes Rationale
  • Change of category name from 'Bulk Active methods of manufacture' to 'Active Ingredient methods of manufacture -Grade 1'.
  • Addition of 'Grade 2' to the existing category 'Active ingredient method of manufacture.
 The revised category names are intended to create consistency in category headings. The varying complexity of active ingredient method of manufacturing changes will be differentiated with the use of different grades, e.g. 'Grade 1, Grade 2, etc '
  • Additional criteria under 'Active Ingredient methods of manufacture - Grade 1' to explain that changes to the manufacturing processes used for the isolation and purification of drug substance from plasma should be notified under this category.
 Changes to the manufacturing processes of blood products have been historically submitted under the category 'Finished product manufacturing process - Grade 1 or 2'.

The manufacturing processes associated with isolation and purification of active ingredients from plasma are technically comparable to those used for the manufacture of active ingredient from other biological and biotechnological products. Only the last formulation and filling steps of the manufacturing process will now be considered finished product manufacturing steps.
  • Introduction of a Self-assessable change notification (SACN) category 'Active ingredient method of manufacture - Grade 3' (fee $360)
 Creation of a SACN category for editorial changes to the active ingredient manufacturing description, or tightening of in-process controls. Introduction of a SACN category more appropriately reflects the level of risk associated with these types of changes.
  • Removal of the category 'Change in site of lyophilisation' (fee $1440).
  • Inclusion of a change in lyophilisation site under the category 'Finished product manufacturing site' (fee $2880)
 Lyophilisation is typically a finished product manufacturing process. Having a separate category for a change in lyophilisation site is unnecessary, as the category 'Finished product manufacturing site' can be selected for this change.
  • Removal of the category 'Revalidation of the lyophilisation process' (fee $1440).
 Revalidation of the lyophilisation process is usually only performed due to a change in lyophilisation process, batch scale, or change in site. There are already appropriate categories in CMN Form B for these changes, making the category 'Revalidation of the lyophilisation process' redundant.
  • Introduction of the category 'Finished Product Testing site' (fee $1440).
 A suitable category for this type of change is currently absent from CMN Form B
  • Revision of the criteria for 'Finished Product manufacturing process - Grade 3' (fee $720).
 The criteria under 'Finished Product manufacturing process - Grade 3' have been revised to include changes to in-process controls (other than tightening limits). Editorial changes that were previously in this category are considered SACN and have been placed in the category 'Finished product manufacturing process - Grade 4'.
  • Introduction of the SACN category 'Finished Product manufacturing process - Grade 4' (fee $360).
 The criteria listed under this category were previously under the category 'Finished product manufacturing process - Grade 3'.
  • Editorial changes to criteria listed under the various 'Test methods and specifications' categories/grades.
 Editorial changes have been made to provide clarity, and clearly describe the components (e.g. active ingredient, finished product) that are covered by the 'Test methods and specification' categories/grades.

Information has been included regarding changes to secondary reference standards, to link the categories/grades that should be selected to those currently described in the GRTPNZ.
  • Introduction of categories for 'Excipient specifications/test methods'.
 These categories have been introduced to provide category options specific to changes to excipients specifications and/or test methods.
  • Introduction of the category 'Shelf life/Storage conditions - Reference standard used for potency/assay'
 CMNs are regularly received requesting extensions to the shelf life of reference standards used for potency/assay. This category has been created to provide an appropriate option on CMN Form B for this type of change.

Invitation to comment

Medsafe is seeking comments from interested parties on the updated CMN Form B. Comments submitted should be specifically with regards to the changes proposed to the form.

Consultation documents

Timetable

  1. Documents released for consultation on 8 May 2018.
  2. Interested parties should respond by close of business on Friday 31 May 2018.
  3. Feedback will be released following consideration of submissions in June 2018.

How to respond

Please complete the Medsafe consultation submission form:

Submissions must include full personal or organisational contact details (including address, telephone number or email address).

Electronic submissions are preferred and should be emailed to medsafeapplications@health.govt.nz, and include 'Revised CMN Form B' in the subject line of the email.

Alternatively, hard copy submissions may be posted to:

Product Regulation
Medsafe
PO Box 5013
Wellington 6140

Next Steps

Submissions will be reviewed by Medsafe and feedback will be provided on the Medsafe website. Input into this consultation will be used to help inform the final content of the revised CMN Form B.

Confidentiality

All submissions may 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 of confidentiality must be included in the space provided on the submission coversheet. These reasons must meet Official Information Act 1982 requirements if the submission (or part thereof) is not to be displayed.

The Official Information Act criteria is available here.

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 parties making submissions may 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 this consultation should be directed via email to: medsafeapplications@health.govt.nz

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