This slide is related to M.pharm regulatory affairs syllabus 1st sem. MHRA is a regulatory body of U.K

1. Tariq Husain
23MPH10001
CHANDIGARH UNIVERSITY
Medicines and Healthcare products
Regulatory Agency[MHRA]

2. WHAT IS MHRA?
 It stands for Medicines and Healthcare products
Regulatory Agency
 it is an executive agency of the Department of
Health and Social Care in the United Kingdom
which is responsible for ensuring
that medicines and medical devices work and are
acceptably safe.
 It was setup in 2003 in order to bring the function
of MCA and MDA.

3. WHAT ARE REGULATORY
BODIES?
 The regulatory body ensures compliances in
various legal and regulatory aspects of a drug.
Every country has its own regulatory authority,
which is responsible to enforce the rules and
regulations and issue the guidelines to regulate
drug development process , licensing,
registration, manufacturing, marketing and
labeling of pharmaceutical products like :
 * USFDA(USA) *MHRA(UK) * TGA(Australia)

4. Different regulatory bodies
1.USFDA (USA),
2. MHRA (UK),
3. TGA (Australia),
4.CDSCO (India),
5.HEALTH CANADA (CANADA),
6.MCC (South Africa),
7.ANVISA (Brazil),
8. EMEA (European Union),
9.SFDA (China),
10.NAFDAC (Nigeria),

5. MHRA formation
.
MCA MRA
MHRA

6. What is MCA?
 MCA was UK licensing authority, part of the
Department of Health before the build up of
MHRA and responsible for safeguarding public
health by ensuring that all medicines meet
acceptable standards.
 Responsible also for clinical trial exemption or
clinical trial certificate.
 MHRA was formed in 2003 with the merger of
the Medicines Control Agency (MCA) and the
Medical Devices Agency (MDA)

7. What is MHRA?
 The Medicines and Healthcare products
Regulatory Agency (MHRA) is an executive
agency of the Department of Health and Social
Care in the United Kingdom which is responsible
for ensuring that medicines and medical devices
work and are acceptably safe. The Medicines
and Healthcare products Regulatory Agency
regulates medicines, medical devices and blood
components for transfusion in the UK. MCA MDA
MHRA

8. History of MHRA
 In 1999, the Medicines Control Agency (MCA) took
over control of the General Practice Research
Database (GPRD) from the Office for National
Statistics. The Medicines Control Agency (MCA) and
the Medical Devices Agency (MDA) merged in 2003
to form MHRA. In April 2012, the GPRD was
rebranded as the Clinical Practice Research Datalink
(CPRD).
 In April 2013, MHRA merged with the National
Institute for Biological Standards and Control (NIBSC)
and was rebranded, with the MHRA identity being
used for the parent organisation and one of the
centres within the group. At the same time, CPRD
was made a separate centre of the MHRA

9. MHRA formation
.
MCA MRA
MHRA

10. OBJECTIVE FOR MHRA?
 Ensuring that medicines, medical devices and blood
components for transfusion meet applicable
standards of safety, quality and efficacy.
 Ensuring that the supply chain for medicines, medical
devices and blood components is safe and secure.
 Helping to educate the public and healthcare
professionals about the risks and benefits of
medicines, medical devices and blood components.
 Promoting international standardization and
harmonization to assure the effectiveness and safety
of biological medicines.
 Manage the Clinical Practice Research Datalink and
the British Pharmacopoeia

11. Some major roles of MHRA.
 MHRA Operate post-marketing surveillance for
reporting,
 Investigating and monitoring of ADR Assessment
and authorization of medicinal products for sale
and supply.
 Operate a quality surveillance to sample and test
medicines to address quality defects and to
monitor the safety and quality of unlicensed
products 1.Monitor and ensure compliance with
statutory obligations relating to medicines and
medical devices. Regulate clinical trials of
medicines and medical devices

12. Marketing Authorization
 Before any medicine can be used to treat people
in the UK, a marketing authorization, from the
MHRA is required.
 The MHRA operates a system of licensing before
the marketing of medicines. Medicines which
meet the standards of safety, quality and efficacy
are granted a marketing authorization (previously
a product license), which is normally necessary
before they can be prescribed or sold.

13. How does the ‘MHRA’ works
 •The Agency has the power to withdraw a product from the
market, and in the case of medicines, to suspend
production if it is not follow any guide line .
 •The Agency can also prosecute[action against in court] a
manufacturer or distributor if the law has been broken.
 •The Agency’s regulatory decisions are impartial and
based solely on the extensive required for each product.
 •Different products are treated differently but the MHRA
considers the particular characteristics, drawbacks and
advantages of each one.
 •The MHRA also collaborates with other international
regulators, such as the US Food and Drug Administration
(FDA), UK government agencies involved in healthcare,
including the National Patient Safety Agency (NPSA) and
the National Institute for Health and Clinical Excellence
(NICE]

14. The MHRA is divided into three main
centres
 MHRA Regulatory – the regulator for the
pharmaceutical and medical devices industries
 Clinical Practice Research Datalink – licences
anonymised health care data to pharmaceutical
companies, academics and other regulators for
research
 National Institute for Biological Standards and
Control – responsible for the standardisation and
control of biological medicines

15. Committees of MHRA
 The MHRA has several independent advisory
committees which provide the UK Government with
information and guidance on the regulation of
medicines and medical devices. There are currently
eight such committees
1.Advisory Board on the Registration of Homeopathic
Products
2.Herbal Medicines Advisory Committee
3.The Review Panel
4.Independent Scientific Advisory Committee
for MHRA database research
5.Medicines Industry Liaison Group
6.Innovation Office
7.Blood Consultative Committee
8.Devices Expert Advisory Committee

16. FUNDINGS OF MHRA
 The MHRA is funded by the Department of Health and
Social Care for the regulation of medical devices,
whilst the costs of medicines regulation is met through
fees from the pharmaceutical industry. This has led to
suggestions by some MPs that the MHRA is too
reliant on industry, and so not fully independent.
 In 2017, the MHRA was awarded over £980,000 by
the Bill & Melinda Gates Foundation to fund its work
with the foundation and the World Health
Organization on improving safety monitoring for new
medicines in low and middle-income countries. In
response to a Freedom of Information request, in
2022 the MHRA stated that approximately £3 million
had been received from the Gates Foundation for a
number of initiatives spanning several financial years.[

17. KEY PEOPLE
 June Raine has been the chief executive of the
MHRA since 2019,succeeding Ian Hudson who
had held the post since 2013.
 The MHRA's strategy is set by a board which
consists of a chairperson (appointed for a three-
year term by the Secretary of State for
the Department of Health and Social Care) and
eight non-executive directors, together with the
chief executive and chief operating officer. The
chair since September 2020 is Stephen Lightfoot,
who is also chair of Sussex Community NHS
Foundation Trust and non-executive chair of
Sussex Primary Care Limited.[
 Sir Michael Rawlins was the chair from 2014 to

18. HOW DOES LICENSING AND
AUTHORIZATION WORK.
 Only when a product satisfies strict safety and quality
requirements and serves the intended purpose are
licences for medications issued.
 • The regulatory system also sets strict requirements
for those who produce medicines and those who deal
in them. • The licensing system ensures that everyone
involved is held accountable, that procedures,
supplies, and quality can be closely examined, and
that prompt remedial action may be taken when
necessary.
 If clinical trials are to be carried out in the UK,
corporations and/or researchers must first submit an
application for authorization to the MHRA.The MHRA
must be convinced that severe safety requirements
have been met in order to grant clearance.

19. Authorization
 All the test results from these trials on how well
the medicine works and its side effects, plus
details of what the medicine contains, how it
works in the body, and who it is meant to treat,
are then sent to the MHRA for detailed
assessment.
 • The assessment team is made up of experts
from different relevant specialties, each of whom
has undergone additional training in medicines
assessment.
 • The length of the assessment process depends
on the type of medicine as well as the quality of
the initial information

20. Why are clinical trials are
important
 As it may directly lead to the patient safety and
efficacy so it is the major concern for the
manufacturers to make a safe and effective
product.
 A medicine/device may work well in the
laboratory, but a clinical trial will find out if it also
works well in people and is safe to use.
 • Clinical trials are phased, and may take several
years to complete.
 The last phase is one of the important phase in
clinical trials cause it includes Post marketing
survillence.

21. How to deal with faulty drug and
devices.
 The MHRA’s Defective Medicines Report Centre (DMRC)
issues alerts to healthcare professionals, hospitals, GP
surgeries, and wholesalers to tell them when a medicine is
being recalled or when there are concerns about the
quality that will affect its safety or effectiveness.
 • These alerts are graded according to the seriousness of
the threat to the public’s health: Class 1 requires
immediate recall, because the product poses a serious or
life threatening risk to health.
 Class 2 specifies a recall within 48 hours, because the
defect could harm the patient but is not life threatening.
 Class 3 requires action to be taken within 5 days because
the defect is unlikely to harm patients and is being carried
out for reasons other than patient safety.
 Class 4 alerts advise caution to be exercised when using
the product, but indicate that the product poses no threat
to patient safety. Most recalls fall into classes 2 or 3.

22. License cancellation
 If MAs holder does not file an application for
renewal within specified time, MAs expires
automatically.
 If the MAs holder does not wish to renew the
licence, a letter should be sent indicating the
cancellation to
 Administrative Support Team and Medicines and
Healthcare products Regulatory Agency (MHRA).
 MHRA has authority to cancel license of product
if it affects public health.

23. ADVERSE EVENTS LEADS
 TO Adverse events are considered serious and
might lead to
 • Death
 • Life-Threatening
 • Hospitalization (initial or prolonged)
 • Disability
 • Congenital Anomaly [birth defect]

24. THANKS
 Thank you for your attention.
 May this slide share help you for your relevant
syllabus