Medicines Industry Liaison Group

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

Background

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

Members

Chair: MHRA Director of Policy

MHRA

MHRA members are drawn from:

• Vigilance Risk Management of Medicines
• Licensing Division
• Inspection, Enforcement and Standards Division
• Communications
• Policy
• Operations and Finance

Government

Government members come from the:

• Department of Health and other government departments
• Better Regulation Unit
• Cabinet Office

Industry members

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)

Secretariat

Policy Division Regulatory Excellence Team

Contact

For further information please contact matthew.garland@mhra.gsi.gov.uk.