Prescription medicine clinical units

Version 2.1, August 2017

11 August 2017

This guidance is for sponsors of prescription medicines.

Our prescription medicine evaluators are organised into units based on the therapeutic indications of the medicines they evaluate. We have five prescription medicine clinical units (PMCUs).

Prescription medicine clinical unit 1

Analgesia

Neurological disorders

  • migraine
  • muscle relaxants
  • insomnia
  • disorders of the inner ear

Excludes:

Psychiatric/Psychological/Behavioural disorders

  • addiction
  • insomnia
  • disorders of libido not due to hormonal deficiency

Excludes:

Anaesthesia

  • general anaesthesia
  • local anaesthesia
  • muscle relaxants

Gastrointestinal disorders

  • pancreatic exocrine enzyme deficiency
  • vomiting
  • combination products (antibiotic + anti-ulcer) for Helicobacter pylori

Excludes:

Poisoning

  • Opioid antagonists

Nutrition

  • Vitamins
  • parenteral and enteral nutrition

Disorders of the mouth

  • topical oral preparations
  • dental products (including local anaesthetics for dentistry)

Excludes:

Disorders of the skin

  • topical therapies
  • topical anaesthetics for use on skin
  • systemic therapies

Excludes:

Prescription medicine clinical unit 2

Infectious diseases

  • antibacterials
  • antivirals
  • antirickettsials
  • antifungals
  • antiparasitics
  • anthelmintics
  • topical anti-infectives (e.g. skin, eye, ear)

Excludes:

Vaccination against infectious diseases

  • Human papillomavirus vaccines (HPV) for prevention of cervical cancer

Immunological disorders

  • immunosuppression following organ transplantation
  • chronic fatigue syndrome
  • systemic sclerosis

Excludes:

  • autoimmune disorders are allocated according to body system

Other

  • radiological agents (e.g. contrast media)
  • adjuncts to radiopharmaceuticals and contrast media use
  • diagnostic tests for infections
  • allergens (diagnostic or therapeutic)
  • antivenenes
  • radiopharmaceuticals for cancer (diagnostic)

Prescription medicine clinical unit 3

Cardiac disorders

Lipid disorders

Inherited metabolic disorders

Vascular disorders

  • cerebrovascular disease
  • hypertension
  • pulmonary Hypertension
  • Deep Venous Thrombosis (DVT)/pulmonary embolus
  • surgical haemostasis (non-plasma products)

Excludes:

Musculoskeletal disorders

  • disorders of joints, muscle
  • disorders of bone
  • drug/device combinations for non-union of fractures

Excludes:

Disorders of the male reproductive system

  • erectile dysfunction
  • benign prostatic hypertrophy

Excludes:

Renal & urinary tract disorders

Excludes:

Disorders of the ear

  • topical otic preparations

Excludes:

Poisoning

  • heavy metal poisoning
  • cyanide poisoning

Excludes:

Prescription medicine clinical unit 4

Neoplastic disorders

Includes:

  • solid tumour oncology
  • hormonal effects of functioning carcinoid neoplasms
  • radiopharmaceuticals for solid tumours (therapeutic)

Excludes:

Prescription medicine clinical unit 5

Contraception

Infertility

Obesity

Osteoporosis

Paget's disease of bone

Endocrine disorders

  • disorders of libido due to hormonal deficiency

Excludes:

Disorders of the female reproductive system

  • endometriosis

Pregnancy and labour

  • post-partum haemorrhage

Fluid & electrolyte disorders

  • hypovolaemia/shock
  • dialysis solutions

Excludes:

Disorders of the eye

Excludes:

Respiratory disorders

Excludes:

Disorders of the nose, paranasal sinuses and upper airway

Excludes:

Prescription medicine clinical unit 6

Haematological disorders, including haematological malignancies

Includes:

  • radiopharmaceuticals for haematological malignancies (therapeutic)

Other

  • surgical haemostasis (plasma products)

Excludes:

Version history

Version Description of change Author Effective date
V1.0

Original publication

Title: Guidance 4: Prescription medicine clinical units (PMCU) - previously ARGPM Appendix 4: Drug safety and evaluation branch clinical evaluation sections

Office of Medicines Authorisation 12/07/2013
V2.0

Update to reflect change in clinical unit structure

Title has been shortened.

Prescription Medicines Authorisation Branch with the Regulatory Guidance Team April 2016
V2.1 Update to the six clinical evaluation streams and the functions each unit provides Prescription Medicines Authorisation Branch August 2017