MHRA

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MHRA

• Introduction to MHRA
• Organisational Challenges
• Scientific Challenges
• Rationale for creating MHRA

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Medical Devices

• All products, other than medicines, used for
  patients in healthcare or in the alleviation of
  injury or handicap.

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MCA

• Budget 50m
• Income Fees
• Staff 500 - Medicines, pharmacy, support
• Regulatory activities Licensing
• Post Licensing
• Inspection Enforcement
• Advertising
• British Pharmacopoeia

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MDA

• Budget 13m
• Income DoH
• Staff 175 - Engineering, medicine, nursing,
  support
• Regulatory activities Post Marketing
• Inspection Enforcement
• Standards

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MHRA

• Budget 63m
• Income Fees and DoH
• Staff 675 - Medicines, pharmacy,
  engineering, support
• Regulatory activities Those of MCA and MDA
• Governance

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Organisational Challenges

• Merger Related - Accommodation
• IT
• Cultural
• Profile and communication
• Public Health agenda
• Europe and International

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Scientific Challenges

• Challenges of new technologies
• Challenge of ensuring patient safety

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Tissue Engineering (1)

• Tissue engineering is that field of medicine
  in which new tissue is created for individual
  patients for the purpose of treating disease or
  injury through the ability of human derived cells
  and a combination of mechanical support and
  molecular signalling processes. Such treatments
  are not achievable by pharmacological or medical
  devices means alone.

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Tissue Engineering (2)

• Cells-autologous or allogeneic
• Mechanical support - natural or synthetic, i.e.
  scaffold or matrix
• Molecular signalling - growth factors
• Examples - skin, cartilage, bone, blood vessels,
  heart valves (bladder, pancreas)

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Tissue Engineering (3)

• World market - 100 billion per year
• UK has second largest TE industry in Europe
• Most products unregulated at present
• EU proposals
• - approval of manufacture, premises, quality
• - evidence of clinical efficacy and safety
• Role of MHRA

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Pharmacogenetics

• The study of interindividual variations in DNA
  sequence related to drug response

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Abacavir Hypersensitivity

• Nucleoside analogue
• Reverse transcriptase inhibitor
• Hypersensitivity 5
• Fever, skin rash, gastro-intestinal symptoms
• Within 6 weeks
• Rechallenge results in a more serious reaction

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Abacavir Hypersensitivity Association with HLA
B57
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Yellow Card
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Patient Safety - Yellow Cards

• Introduced in 1964
• Data base of 500,000
• 20,000 per year submitted
• Reports for ADR from new drugs - and all serious
  ADRs
• Linked to - ADROIT
• - National data bases
• - International data bases

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Rationale for creating MHRA

• Organisational
• Scientific