Revised: 27 May 2013

Consultations

Medsafe signals planned changes to GMP evidence required for active pharmaceutical ingredients

7 December 2012

To:
Product sponsors
Applicants for new and changed medicines
Regulatory affairs consultants

This letter is to:

• signal changes to the good manufacturing practice (GMP) evidence required for active pharmaceutical ingredients in prescription medicines
• outline implementation and transition arrangements
• provide a contact point for queries or feedback on the proposed changes.

Background

International best practice is that active pharmaceutical ingredients (APIs) are manufactured according to ICH Guideline Q7. The intent of the guideline is that APIs should be manufactured in accordance with the principles of good manufacturing practice (GMP). In line with this guideline, Medsafe has decided that applications for new prescription medicines should be accompanied by acceptable evidence of GMP that includes the API manufacturing site.

Acceptable evidence is certification by a recognised regulator (refer to NZRGM part D section 5.5). Evidence of GMP must be submitted in addition to Certificates of Suitability or Drug Master Files to demonstrate the manufacturing site maintains an appropriate quality management system.

CChanges that may affect the quality of the API in a prescription medicine should be submitted as a changed medicine notification and accompanied by acceptable evidence of GMP.

Next steps

The target implementation date for the changes described above is 1 April 2013.

Queries about, or comments on, the changes described above should be sent to

Sarah Reader
Manager Product Regulation Medsafe
PO Box 5013
WELLINGTON

Email askmedsafe@health.govt.nz

by Thursday 31 January 2013.

Comment on the feedback received and any resulting adjustments to the new requirements will be provided through the Medsafe website (www.medsafe.govt.nz).

Yours sincerely

Sarah Reader
Manager Product Regulation