Drug approval

Question 1

How are drugs licensed in the UK?

Answer 1

Medicines and Healthcare Products Regulatory Agency(MHRA)

Question 2

How are drugs licensed in Europe?

Answer 2

European Medicines Agency(EMA) for a Europe wide licence, under laws set by theEuropean Commission

Question 3

How are drugs processed by the EMA?

Answer 3

All new drugs are looked at using a process called the centralised (or community) authorisation procedure.

Question 4

Where does EMA approval give marketing authorisation?

Answer 4

a marketing authorisation (licence) for all EU countries, plus Iceland, Liechtenstein and Norway.

Question 5

what else is the MHRA is responsible for?

Answer 5

the approval of clinical trials carried out in the UK

regularly inspecting laboratories and pharmaceutical companies

sampling medicines to ensure they meet quality standards

collecting and reviewing evidence about drug side effects from patients and health care workers

gathering information about fake medicines

Question 6

Once approved, how can the drug be used?

Answer 6

A drug is usually licensed to treat a specific type of illness (indication).
can be used within the license

Question 7

what is ‘off-label prescribing’

Answer 7

Sometimes a doctor might feel that a particular drug could help a patient with a condition not included in the drug licence.

In this case, they can prescribe that drug for the patient.

But the doctor has to take full responsibility for the outcome.

Question 8

what is NICE?

Answer 8

National Institute for Health and Care Excellence

Question 9

what is their role in drug development in UK?

Answer 9

Once a drug is licensed, NICE might assess it to see whether it should be widely available on the NHS in England.