Access is a coalition of like-minded medium-sized regulatory authorities. The participating authorities face very similar challenges, such as increasing workload, increasing complexity and at the same time increasing pressure on the available resources.
The Consortium was renamed from the previous Australia-Canada-Singapore-Switzerland Consortium (ACSS) in October 2020, with the introduction of its newest consortium member, the U.K. Medicines and Healthcare products Regulatory Authority (MHRA). The MHRA will officially commence working with consortium partners as a full member on 1 January 2021. The new name reflects the group’s key aim of providing patients with timely access to high-quality, safe and effective therapeutic products in the member countries.
The members of the Access consists of health regulatory agencies from:
- Therapeutic Goods Administration (TGA) of Australia;
- Health Canada of Canada;
- Health Sciences Authority (HSA) of Singapore
- Swissmedic of Switzerland; and
- Medicines and Healthcare products Regulatory Authority (MHRA) of the United Kingdom (effective 1 Jan 2021)
The Consortium meets on a regular basis to exchange information on issues and challenges. The collaboration aims to better align the regulatory systems and reduce unnecessary duplication and differences.
The Consortium also explores opportunities for information and work-sharing initiatives.
Complementary Health Products Working Group
The Complementary Health Products Working Group (CHPWG) was formed in 2015 to promote regulatory collaboration, share information, so as to work towards the standardisation of the technical guidelines and requirements for the assessment of CHP.
The Work Group was initially formed to focus on the following scope:
- Assessment of CHP ingredients with safety concerns
- Development of methodology and framework for safety assessments
- Reviews of appropriate cautionary labelling for CHP
- Information updates of new developments in CHP regulation
- Sharing of evaluation standards or requirements with regard to non-conventional technologies applied in the manufacture of CHP ingredients
Its scope was further expanded in 2018 to cover efficacy assessment of CHP ingredients with novel or contentious uses.
The CHPWG members had conducted peer review safety assessments on a number of ingredients that are of mutual interest. To facilitate the joint safety assessments amongst the member authorities, the CHPWG had developed the following documents as guidance references:
- Guidance on the Calculation of the Acceptable Daily Intake (ADI) for Safety Assessment of CHP Ingredients
The guidance consolidates the necessary considerations to be taken when setting a safe threshold value that is unlikely to pose a health risk to the general public for a CHP ingredient. It standardises the adjustment factors which can be applied to derive at a reliable and robust safe level in the human population, after studying the guidance from the International Programme on Chemical Safety, US Food and Drug Administration and Joint FAO/WHO Expert Committee on Food Additives. It also covers the methods in the establishment of the Acceptable Daily Intake (ADI), Estimated Daily Intake (EDI) ratio, as well as the Margin of Safety (MoS) values for CHP ingredients.
- Guidance on Minimum Data Requirements for Safety Assessment of CHP ingredients
This guidance defines a set of essential information required before commencing the safety assessments of a CHP ingredient by the Work Group. It helps to provide a common starting point for assessing the vital information on the concerned ingredients. The document makes reference to the current data requirements for each member country, as well as the guidelines from the European Medicines Agency, European Food Safety Authority and the US Food and Drug Administration.