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Consultations

Revised: 24 April 2013

Outcome of Consultation on the Proposed Changes to GMP Evidence Required for Active Pharmaceutical Ingredients

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).

Background

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).

Outcome

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.

Feedback received

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.

Issues raised in the consultation

The submissions raised the following issues for consideration by Medsafe:

1. Request for clarification on the proposal for CMNs.
   Evidence of GMP must be submitted with the CMN when registering a new API manufacturing site for an approved prescription medicine.
   GMP evidence is not generally required when notifying a change (e.g. to manufacturing process or specifications) at an approved site, provided the change(s) remain within the general scope of activities included in previously approved submissions.
2. The GMP requirements for OTC medicines should be harmonised with Australia.
   The GMP requirement for OTC medicines is unchanged. It is intended to harmonise the GMP requirements for the establishment of ANZTPA.
3. Request for clarification of acceptance of the European Qualified Persons Programme.
   The QPP is not acceptable in lieu of GMP certification by a Medsafe-recognised authority. However, GMP evidence will not be required for API manufacturing sites included in applications submitted via the abbreviated route, when all of the following conditions are met:
   • the application is eligible for the abbreviated route, and has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) or by the European centralised, decentralised or mutual recognition procedure, and
   • European acceptance of the API manufacturing site was based on a QPP, and
   • the finished product manufacturer is located in Europe, and
   • the medicine is not a vaccine or higher-risk biological medicine, and
   • the application includes the latest audit report from the QPP for the API site.

Yours sincerely

Sarah Reader
Manager Product Regulation
Medsafe