3) Human Medicines Regulations, Advertising and Licensing

Question 1

How long does it take for a chemical compound to go from the lab to the
pharmacy shop as a medicine?

Answer 1

An average of about ten years

Question 2

When was the first

comprehensive UK regulatory system introduced?

Answer 2

1971, they were introduced as part of the implementation of the requirements of the Medicines Act of 1968. And, basically, introduced the
need for licences to be issued to provide authority to people or organisations to carry out the whole range of activities associated with drugs. So, licensing covered the manufacture, sales, supply, and importation of drugs.

Question 3

What became unlawful in 1971?

Answer 3

it became unlawful to engage with these activities except in accordance with appropriate licences and certificates or exemptions. So,
basically, the regulations stopped people doing any of these activities unless a licence had been
granted. And in issuing the licence, the licensing authority, they have to be satisfied as to the level of risk to the public and patients.

Question 4

Who is the licensing body for the UK?

Answer 4

Now, key organisations are involved in regulating medicines. And they are Medicines and Healthcare
Products Regulatory Agency, the MHRA.

Question 5

How many medicines do the MHRA cover?

Answer 5

Around 20,000 available in the UK

Question 6

How are medicines granted by the MHRA?

Answer 6

If the product has met high standards of the three vital components of safety, quality, and efficacy.

Question 7

How does a product get a license?

Answer 7

• Marketing authorisation is required before any medicine can be used to treat patients in the UK.
• The starting point towards getting that marketing authorisation is that the company or the producer of that medicine needs to have
  permission to conduct a clinical trial.
• Clinical trial results are produced to the MHRA and they are assessed by the MHRA.
• If results are acceptable, then the product is given marketing
  authorisation or a product licence.
• A key document is required to, as part of the licensing process is the summary of product characteristics, the SPC. And they are available online for many drugs on
  this particular website.

Question 8

What needs to be included within that document?

Answer 8

• name of the product,
• composition of the product, which includes actives, the actual ingredients, and the excipients.
• The pharmaceutical form,
• the pharmacological properties,
• the clinical particulars, and the pharmaceutical particulars.

Question 9

Phase one of clinical trials?

Answer 9

usually involves healthy
people. And it’s designed to find out how the medicine works in the body and to see if side effects
increase at higher dosages. And this study, often, involves less than 100 people. If everything is fine
and the results are safe, effective, and of high quality, then a phase two clinical trial will proceed.

Question 10

Phase two?

Answer 10

That examines whether the medicine work in patients with a particular condition or disease.
They can also identify common short-term side effects. And the size of the cohort, the size of the
population that’s tested is around 700 people.

Question 11

Phase three?

Answer 11

In phase three, the aim is to gather further
information on how well the medicine works and how safe it is in the general population. And it’s
more, in more detail of the range and degree of side effects. So, the breadth of them.

Question 12

What do the

results of these trials inform?

Answer 12

Informs the labelling and patient information for the medicine when it’s marketed.

Question 13

If the product received a favourable result from this

phase of clinical trial…

Answer 13

…the regulatory body will issue marketing authorisation. Otherwise, known as
product licence, to allow the product to be placed on the market. However, further monitoring must
take place.

Question 14

What is the further monitoring also known as?

Answer 14

the post-licensing

Question 15

Some rare and unexpected
side effects may only occur after the medicine has been in use for several years. What is this process of monitoring known as?

Answer 15

pharmacovigilance

Question 16

Phase four?

Answer 16

That’s information supplied from manufacturers from phase four clinical trials can show there have been issues. The phase four clinical trials are carried out after the product
has been licensed, put on the market, and prescribed to patients. These trials, they generally look to
find out more about long term harms and benefits of the medicine and to discover new uses for it.
Other routes by which problems can be identified.

Question 17

Yellow Card Scheme?

Answer 17

Scheme that reports on side effects.
- Healthcare
professionals, coroners, and the public can report ADR’s, so that’s adverse drug reactions to the MHRA, by using the yellow card scheme.
- There is a website where the, the actual yellow card form
can be found and is completed. The yellow card scheme, today, receives more than 20,000 reports of possible side effects, each year. And to give you an idea of how that’s grown. Half a million reports received in the scheme’s first 40 years.

Question 18

Black triangle drug?

Answer 18

The black triangle denotes that a medicine is on a list of medicines subject to additional monitoring.

Question 19

Other routes by which problems can be identified?

Answer 19

• Research can be carried out on anonymised patient records.
• There could be quality checks on products by the MHRA.
• Or you could get tipoffs about criminal activity.

Question 20

Warnings or alerts can be issued about defective medicines and side effects associated with
medicine. How are they issued?

Answer 20

via communication systems, so either email, faxes etc

Question 21

Class one alert?

Answer 21

Alerts required immediate recall because the product poses serious or life-threatening risk to health.

Question 22

Class two?

Answer 22

specify the recall within 48 hours because the defect could harm the patient, but is not
life-threatening.

Question 23

Class three?

Answer 23

That requires action to be taken within five days because the defect is unlikely to harm patients, but is being carried out for reasons other than safety. Now, something like that could be the wrong information on a patient information leaflet or the box has some defects that the medicine is in.

Question 24

Class four?

Answer 24

Where you would advise caution to be exercised when using the product, but
indicate the product poses no threat to the patient’s safety.

Question 25

What are exceptions to the MHRA?

Answer 25

The exception to this is decisions on Marketing Authorisation (MA) applications made through the European procedures to market products in Northern Ireland.

Question 26

What will be a phased process?

Answer 26

There will be a phased process between 1st Jan 2021 and 30th June 2023 determining the
import of medicines from the EEA. Wholesalers must notify MHRA of intention to continue
to import from a designated country and there will be measures in place, such as having a
designated responsible person to assure the quality of the product etc. (Responsible Person
(import) RPi)