The Medicines Industry Liaison Group (MLG) works with the medical industry to develop recommendations for MHRA's burden reduction/simplification programme.
Role of the group
Terms of reference
To ensure industry stakeholder participation in development and evaluation of Medicines and Healthcare Products Regulatory Agency (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
The MHRA has established the MHRA MLG in order to work co-operatively with industry in our burden reduction/simplification programme.
Throughout the Red Tape Challenge Process to date, MHRA has held regular meetings with industry stakeholders to discuss burden reduction/simplification issues and it was found that this co-operation was valued across the piece.
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 MLG will allow the MHRA to work with pharmacy and industry stakeholders to continue to:
- monitor Red Tape Challenge implementation
- keep informed of proposed changes to the Regulatory Excellence Programme
- ensure that the approaches to better regulation are applied consistently throughout the MHRA
- provide a structured forum for industry to bring papers on the impact of regulatory activity and make recommendations for regulatory reform
- discuss guidance with the MHRA
Chair: MHRA Director of Policy
MHRA members are drawn from:
- Vigilance Risk Management of Medicines
- Licensing Division
- Inspection, Enforcement and Standards Division
- Operations and Finance
Government members come from the:
- Department of Health and other government departments
- Better Regulation Unit
- Cabinet Office
Industry is represented by:
- ABPI (Association of the British Pharmaceutical Industry)
- BGMA (British Generic Manufacturers Association)
- PAGB (Proprietary Association of Great Britain)
- EMIG (Ethical Medicines Industry Group)
- BIA (BioIndustry Association)
- Perrigo Herbal Forum
- BAHM (British Association of Homeopathic Manufacturers)
- NPA (National Pharmacy Association)
- CCA (Company Chemists’ Association)
- AIMp (Association of Independent Multiple pharmacies)
Policy Division Regulatory Excellence Team
For further information please contact email@example.com.