There has been increasing interest (on a global level) in the therapeutic properties of medicinal cannabis. Now, New Zealand (NZ) released a proposed regulatory approach for medical cannabis. The Government expects to finalise the regulations by December 18, 2019. The implementation of the medical cannabis scheme is then anticipated to take place in the first quarter of 2020. Comments on the proposal should be sent until August 7, 2019. The NZ Ministry of Health will analyse the feedback and will work together with the Medicinal Cannabis Advisory Group on recommendations before providing advice to the Government. The Ministry of Health will then seek approval from Cabinet on the regulatory proposals.
New Cannabis Agency
Like in Germany, first of all a Medicinal Cannabis Agency has to be established in NZ. Amongst others, the NZ Cannabis Agency's responsibilities would be:
Licensing of growers, processors, manufacturers, importers, exporters and wholesale distributers of medicinal cannabis products;
Monitoring compliance with license conditions and quality standards;
Monitoring unapproved medicinal cannabis products for adverse effects;
Collecting and reporting on data to the International Narcotics Control Board (INCB) about medicinal cannabis production and use in New Zealand;
Developing or endorsing guidance for the use of medicinal cannabis products;
Monitoring the Medicinal Cannabis Scheme to assess progress in achieving its objectives.
There are three different options proposed for the quality management of the cultivation process:
Manufacturers would determine the desired quality for the starting material. This could be requiring compliance with Good Agricultural and Collection Practices (GACP) or setting product specifications for starting material. The Cannabis Agency would license the cultivation activity but would have no direct oversight of the quality of the starting material. No quality standard would be set by the regulator for cultivation.
The regulator would set a cultivation process standard such as GACP, or a similar agricultural process standard, to address the specific requirements of growing, collecting and primary processing of cannabis plants. Under this proposal, the regulator would inspect the cultivator`s agricultural practices. The cultivator would be responsible for documenting and conducting quality controls, processes and SOPs to meet GACP. Aspects that could be considered for inspection under this proposal would include: - pesticide use, - fertilisers, growth promoters, growth regulators and irrigation (water quality), - growing mediums (soil or another substance through which plant roots grow and extract water and nutrients), - harvest, drying and processing, - destruction of unneeded organic material.
The regulator would set a product quality standard for starting materials. The aspects of the starting material to be tested include - Identity of the plant, - Active ingredients, - Microbiological contamination, - Pesticides, heavy metals, mycotoxins etc. Under this proposal, the regulator would set the New Zealand Product Quality Standards (PQS) Monograph (provided in Appendix 2 of the proposed document, similar to a pharmacopoeial monograph) as the quality standard for starting material. The cultivator would be responsible for ensuring that the starting material meets the quality standard, and would be required to provide evidence and documentation to prove this. The Cannabis Agency would be responsible for reviewing the evidence to verify that the starting material meets the PQS.
Appendix 2 states that the identification of the cannabis inflorescence is well defined within the American Herbal Pharmacopoeia: Cannabis Inflorescence and Leaf (2013). According to the text, the European Pharmacopeia (Ph. Eur.) is expected to publish a cannabis monograph in 2019, at the time of publication this should be considered the definitive text.
GMP vs. GPP
Currently in NZ, the quality manufacturing standard followed by all medicines manufacturers is Good Manufacturing Practice. The EU-GMP Guidelines and the New Zealand Code of GMP (based on the PIC/S GMP Guide) are noted as being ‘practically identical’, with only a few minor differences. However, "there are a number of areas where the two standards GMP and GPP do not align" (Good Production Practice, similar to Canada's GPP). "The GMP guidelines are more detailed, providing principles and interpretation on what must be included in a quality management system to comply, while the GPP standard provides less detail and is therefore more open to interpretation. This difference makes it difficult to directly compare the two standards". For example, stability testing is not required under GPP. Under GMP, the stability programme designed in accordance with the ICH Q1 Guidelines is required to establish the shelf life of the product.
Therefore, there are two options for a manufacturing process quality standard proposed:
Adopt the current NZ approach for manufacturing in accordance with GMP (Medicines Act) for all medicinal cannabis products, or
Allow for the manufacture of some medicinal cannabis product dosage forms under GMP (Medicines Act) and some medicinal cannabis dosage forms under GPP (Misuse of Drugs Act).