Revised: 24 April 2013
To: Product sponsors
The purpose of this letter is to advise you of the outcome of Medsafe's consultation on the proposed changes to GMP evidence required for sites manufacturing active pharmaceutical ingredients (APIs).
In December 2012, Medsafe published a proposed new business rule for acceptable evidence of GMP for API manufacturing sites on the Medsafe website, and sought feedback on the proposal by 31 January 2013.
Medsafe received three submissions on the proposed changes (one from an industry association and two from sponsors of medicines).
From 1 June 2013, new prescription medicine applicants will be required to provide acceptable evidence of GMP for the API manufacturing site from a Medsafe-recognised regulatory authority in addition to a DMF or CEP.
From 1 June 2013, sponsors who are adding a new API manufacturing site for a prescription medicine will need to provide acceptable evidence of GMP for that site from a Medsafe-recognised regulatory authority in addition to a DMF or CEP.
The list of Medsafe-recognised authorities is available in section 5.5 of Part D of the NZRGM.
The GMP requirement for manufacturers of APIs used in OTC medicines is unchanged.
The Qualified Persons Programme (QPP) is not acceptable in lieu of GMP. However, GMP evidence will not be required at this stage for API manufacturing sites included in applications submitted via the abbreviated route and based on European approval, where European acceptance of the API manufacturing site was based on a QPP.
The New Zealand Regulatory Guidelines for Medicines (NZRGM) will be updated to reflect this revised policy.
Only three submissions were received. One requested clarification of the requirements pertaining to CMNs and one requested that OTC medicines be exempt from GMP certification. A third submitter requested recognition of the QPP.
The submissions raised the following issues for consideration by Medsafe:
Manager Product Regulation