the regulator is responsible for ensuring compliance and undertaking enforcement or regulatory actions such as issuing recall notices.putting in place a surveillance system for monitoring, collecting, analysing, and investigating information on product safety, quality and efficacy/ performance.The regulator and product sponsor will be responsible for managing the risks of a therapeutic product and taking appropriate steps to deal with any issues identified, including: Consistent with international practice, the sponsor, as the market authorisation holder, will have special responsibilities under the Bill. The Bill mandates the monitoring and reporting of safety issues for both the regulator and sponsor. compliance and monitoring (such as product standards and any conditions of a product’s market authorisation).ensuring products remain safe and meet required quality and efficacy/ performance standards.Post market regulation of therapeutic products has two purposes: Once a product is authorised, it will also be subject to regulation. The Bill will regulate activities across a therapeutic product’s lifecycle - this includes product development, pre-market activities (such as clinical trials and manufacturing), and the authorisation of the product for import, supply or export. If you want to get in touch with the team, you can email us at: mihi Please forward our newsletter to any of your colleagues who would be interested and look out for our next update. We’ve also provided an update on NHPs and the establishment of our implementation team. In this newsletter, we’ve highlighted some of our key engagements and give an overview of how the Bill applies to post market activities, biologics, and clinical trials. We’ll be continuing our ongoing engagement with stakeholders as we head towards the introduction of the Bill to Parliament in late 2022. We’ve been mindful of how the principles apply across all sectors and activities covered by the Bill. We’ve been working closely with our colleagues in Te Aka Whai Ora – the Māori Health Authority - on how best to reflect the principles of the Te Tiriti o Waitangi in the Bill. In preparing the Bill, we’re taking care to ensure it is future-looking, flexible and sensitive to the needs and aspirations of all New Zealanders, including Māori, Pacific peoples and the disabled community. The purpose of the Bill is to protect, promote and improve the health of all New Zealanders by providing for acceptable safety, quality and efficacy of medicines and medical devices, and acceptable safety and quality of NHPs. The Bill has almost doubled in size due to the feedback on the exposure draft, the health system reforms, lessons from COVID-19 and the need to include regulation of natural health products (NHPs). We’ve been working at pace with the Parliamentary Counsel Office (PCO) on this. Our top priority remains the drafting of the Therapeutic Products Bill. Welcome to the latest edition of our newsletter.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |