The document summarizes updates from New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) and manufacturing quality branch. It discusses the proposed Therapeutic Products Bill, which will modernize regulation of medicines, medical devices, and other therapies. It also covers GMP code updates, electronic submissions, and fees reviews. The COVID-19 pandemic has significantly impacted on-site GMP inspections internationally, requiring increased reliance on remote inspections and information sharing between regulatory authorities.

1. ARCS 2021
NZ MEDSAFE update
Manufacturing quality branch update

2. New Zealand updates
• The Therapeutic Products Bill will:
Repeal and replace the Medicines Act 1981
Provide modern assurance of the safety, quality and efficacy
Takes a risk-based approach, ensuring benefits of products outweigh risks
Provide comprehensive coverage of therapeutic products including:
• Medicines
• Advanced gene, cell and tissues therapies
• Medical devices
Will address product approval pathways, supply chain activities and post-market controls
Continue to align with international regulatory best practice, supporting international cooperation
and reliance

3. Next steps for the Therapeutic Products Bill
• The Ministry consulted on a draft Therapeutic Products Bill in 2019
• The Ministry’s immediate focus remains finalising and processing the Bill
• The team work closely with Medsafe and are continuing to engage with the sector
• Aiming to introduce the Bill in this parliamentary team (before Christmas or asap
in 2022)
• Formal consultation when the Bill is considered by the Select Committee
• Then move to develop the detailed Regulations and other instruments like
Regulator Notices
• There will be further consultation on the draft Regulations

4. Other trends and hot topics
• GMP code update
• NZ moving to PCIS code – PE009/14
• Companies have until November to comply
• Mainly extending or clarifying current code requirements
• Electronic file transfer
• Piloted in late 2019
• Roll out March 2020 (Covid)
• Positive feedback
• Updates and storage (increasing the storage for the dossiers)
• Future work on eCTD (no dates yet)
• Fees review
• Last review 3 years ago
• Change to variation types - costs need to be efficient and proportionate

5. Manufacturing quality branch update
• The covid-19 impact on GMP for regulators
• GMP oversight has been significantly impacted
• The ability to perform routine on-site inspections of manufacturers is continually at risk during
pandemic
• The flow on effect to inspection reliance adds pressure on existing regulatory frameworks
• Remote or Virtual GMP inspections add additional layers of complexity for regulators
especially for overseas manufacturers
• Compliance and monitoring approaches are impacted with a reduction in routine GMP signals
• International collaboration and harmonisation on remote or virtual GMP inspections as well as
inspection reliance considerations take on increased importance

6. TGA’s response
• MRA Pathway
• Increased TGA’s collaboration with MRA partner regulators
• Started accepting ‘distant assessment’ certificates
• Aligned expiry dates to the end of 2021 in line with European guidance
• GMP Clearance
• Introduced GMP Clearance questionnaire to bridge the gap between the last on-site
inspection and the current GMP assessment
• Requested additional documents for assessment
• Allowed additional time for Sponsors and manufacturers to address questions raised during
assessment