The MHRA has established the MHRA Medicines Industry Liaison Group (MLG) in order to work co-operatively with industry in its burden reduction/simplification programme.
The MLG will run quarterly and will succeed the existing Better Regulation of Medicines Initiative (BROMI). Any new better regulation projects will feature under the burden/reduction/simplification element of the Regulatory Excellence Programme and will be discussed at the MLG.
The group will be chaired by the MHRA Director of Policy and includes representation from the Department of Health as well as several industry bodies including ABPI, BIA (BioIndustry Association), BGMA (British Generic Manufacturers Association) and the EMIG (Ethical Medicines Industry Group).
To ensure industry stakeholder participation in development and evaluation of MHRA policy by providing a forum for discussion about proposals and agreeing recommendations for regulatory reform. To achieve this the group will:
- Consider the impact of existing and planned regulatory requirements (legislative and non-legislative) and make recommendations for regulatory requirements which are proportionate to the risk and benefit to public health;
- Consider the impact of process and Information Technology changes in MHRA on business;
- Co-produce a process for impact assessments as a pioneer of the Accountability for Regulatory Impact project;
- Engage businesses on implementation of Red Tape Challenge proposals and monitor delivery;
- Have a role in the production of MHRA guidance.