Prescription medicine clinical units
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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.
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:
- topical otic anti-infective preparations (PMCU 2)
- disorders of the inner ear (e.g. Meniere's disease - PMCU 1)
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:
- haematological malignancies (PMCU6)
- hormonal effects of other functioning neoplasms (e.g. pituitary, thyroid, adrenal - PMCU 5)
- HPV vaccines for prevention of cervical cancer (PMCU 2)
Prescription medicine clinical unit 5
Contraception
Infertility
Obesity
Osteoporosis
Paget's disease of bone
Endocrine disorders
- disorders of libido due to hormonal deficiency
Excludes:
- hormonal effects of functioning carcinoid neoplasms (PMCU 4)
- disorders of libido not due to hormonal deficiency (PMCU 1)
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 |
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