The Ministry of Health is seeking feedback on a draft Therapeutic Products Bill that would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products in New Zealand.
Categorising the current regulatory regime as dated, inflexible and prescriptive, the Government is seeking to introduce therapeutic products legislation that can keep pace with changing international regulatory practice and emerging technologies.
The most significant changes from the current regime are:
pre-market controls on medical devices, which are largely unregulated
broader product coverage to include cell and tissue products and radioactive medicines
provision of a wider range of tailored and responsive regulatory tools to encourage compliance and deal with serious offending.
Natural health products are largely excluded from the Bill, as the Government is considering other options for regulating these.
The draft Bill can be found here: https://www.health.govt.nz/system/files/documents/publications/therapeutics-products-bill.pdf, and the the consultation document here: https://www.health.govt.nz/system/files/documents/publications/therapeutic-products-regulatory-scheme-consultation-document_dec18.docx.
The deadline for public submissions on the Bill is 18 April 2019. If you have any questions about the Bill, or would like to make a submission, please contact us.