Human Medicines Regulation Flashcards
What is the process of drug development?
- Development of new drug
- Manufacturing
- distribution
- sale and supply
Takes 10 years, and there are many regulatory requirments
What regulations did the medicines act lead to?
People needing licenses for the manufacture, sale and supply and importation of medicines. Stopped anyone doing these things without a license
What is the MHRA?
The medicines and healthcare regulations Agency, UK
How are medicines regulated?
In the UK, the MHRA and the EMEA work closely together and create a collaborative network of regulatory bodies in Europe. It is a central procedure. A single Market Authorisation is submitted to EMEA, and becomes valid in all member states.
Who grants marketing authorisation for drugs in the UK?
MHRA
How are medicines licensed?
- Clinical trials - must be approved to conduct. MHRA review, if successful given MA/license
- SPC - name, composition, pharmaceutical form, pharmacological form, clinical procedures
Phase I clinical trials
tested on healthy people
shows how the drug works
tested on less than 100 people
Phase II clinical trials
- Tests medicines in patients with disease
- identify short term common side effects
- 100s people
Phase III clinical trials
- How effective and safe the drug is
- range and degree of side effects
- in form labelling and patient information leaflet
- 100-100s
- good result but issues = MA but monitoring required
Monitoring (Phase IV clinical trials)
- looks at long term harm
- yellow card
- black triangle
- research
- quality checks (MHRA)
- criminal activity
What is the yellow card scheme?
Scheme used for reporting adverse drug reactions
What is a black triangle drug?
Medication recently brought into the market.
- drug on probation
- pharmacovigilance
- all side effects must be reported
Quality checks
- must be reported to the MHRA
- class 1 = immediate recall as could result in death
- class 2 = recall in 48 hours - no risk to life
- class 3 = action in 5 days, unsafe due to something like incorrect info in PIL
- class 4 - caution with use, no threat to safety
What are the 3 main regulated aspects of drug advertising?
- cannot advertise a medicine which is not market authorised with an SPC, must be consistent with SPC
- can’t publish unless encourages rational use of the product
- cannot be misleading
How is pharmacovigilance enforced?
- licensing authority must promote reporting of any adverse drug reactions (yellow card scheme)
- public given information on pharmacovigilance concerns
- identify products with ADR
