Asia – Asia-Pacific Roundup

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is going ahead with its planned changes to good manufacturing practices (GMPs) after receiving largely positive feedback to a consultation.

In February, Medsafe began gathering views on its plans to adopt the updated PIC/S Guide to GMP. The change would replace a GMP code from  2009 with a version adopted by PIC/S, the Pharmaceutical Inspection Co-operation Scheme, in 2018. Doing so will bring significant changes to how Medsafe approaches topics including cross-contamination and starting materials, according to the agency.

Medsafe received feedback from five respondents. Four agreed with Medsafe’s proposed timing of the transition to the new rules, which would see the updated GMP code take effect on 3 May and give the industry until 3 November to fully adapt to the revised rules. The fifth respondent called for more time to implement the updated code…