TGA Opens Consultation on Rolling Adoption’ of PIC/S GMP Changes

Australia's Therapeutic Goods Administration (TGA) has opened a consultation on implementing a 'rolling adoption' of new good manufacturing practice (GMP) versions of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S), two international instruments designed to improve co-operation between regulatory authorities and the pharmaceutical industry.

The proposal would automatically adopt the new PIC/S changes during a transition period of six months from the date of publication, in combination with an improved industry consultation process on future PIC/S revisions.

PIC/S has indicated that following the introduction of the 'rolling' adoption' proposal, it would be willing to amend its revision process to allow full consideration of the outcomes of TGA's industry consultations before the PIC/S revision is finally adopted.  Comments on the proposal are due by 10 July 2013.

Adoption of harmonized standards is crucial to maintaining the mutual equivalence of Australia with its Mutual Recognition Agreement (MRA) partners (the EU, Switzerland, Canada, Singapore) and partners with which a Memorandum of Understanding (MOU) is effective, such as the USA. In addition to Australia, the PIC/S GMP standard is used by the European Union and New Zealand, whereas others (Canada, USA, Singapore) have their own national GMPs that are substantially aligned with the PIC/S.