REGULATORY REQUIREMENTS OF MHRA

1. REGULATORY
REQUIREMENTS OF MHRA
PRESENTED BY
NIVEDITHA G
1stMpharm(pharmaceutics)
NARGUND COLLEGE OF PHARMACY

2. MHRA
MEDICINES AND HEALTH CARE PRODUCTS REGULATORY AGENCY
History of MHRA
MCA (Medicines Control Agency) was UK licensing authority, part of the
Department of Health, responsible for safeguarding public health by ensuring that
all medicines meet acceptable standards, and responsible for clinical trial.
MHRA (Medicines and Healthcare products Regulatory Agency) was formed in
2003 with the merger of the MCA (Medicines Control Agency) and the MDA
(Medical Devices Agency).

3. In April 2003, it merged with the National Institute for Biological
standards and Control (NIBSC) and was rebranded with MHRA
identity being used solely for the regulatory center with in the
group.
MHRA: The MHRA (Medicines and Healthcare Products
Regulatory 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
(MHRA) regulate medicines, medical devices and blood
components for transfusion in the UK

5. RESPONSIBILITIES OF 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.
• Promoting international standardization and harmonization to assure the
effectiveness and safety of biological medicines.

6. • Helping to educate the public and healthcare professionals about
the risks and benefits of medicines, medical devices and blood
components leading to safer and effective use.
• Supporting innovation and research development that helps for
public health.
• Influencing UK,EU and international regulatory frameworks so
that they are risk reducing and effective at protecting public
health.

7. ROLE OF MHRA
• Operate post-marketing surveillance for reporting, investigating and
monitoring of ADR to medicines and incidents with medical devices.
• Assessment and authorization of medical products for sale and supply in
UK.
• Operate a quality surveillance to sample and test medicines to address
quality defects and to monitor the safety and quality of unlicensed
medicines.
• Monitor and ensure compliance with medicines and medical devices.
• Regulate clinical trials of medicines and medical devices

8. • Undertake post marketing surveillance includes
Pharmacovigilance
Quality defect monitoring
Sampling and testing
Product recalls

9. MEMBERS OF MHRA
MHRA Governance / Membership: The Agency board is made up of
• Non-executive Chairman.
• 6- Non executive members and
• Agency’s Chief Executive officer.
• The agency’s Chief Executive officer is responsible for Service
delivery and resources.
• The Executive Board consisting of the Agency’s directors.
• The Executive Board’s primary responsibility is to ensure strategic
direction set by the Agency board is implemented and reflected in the
day operations of the Agency.

10. Functions of MHRA
I. Regulation of clinical trials.
II. Safety and efficacy monitoring.
III. Providing information to public and health professionals.
IV. Licensing
▪ Manufacture and dealer licenses.
▪ Clinical trial licenses.
▪ Parallel import licenses.

11. LICENSING PROCESS

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. Product Require Market Authorization
• New biological or chemical compounds.
• Different brands of existing medicines.
• Generics New dosage forms of existing medicines.
• New uses for existing medicines such as different
conditions.

14. Renewal of License
• New Marketing Authorizations (MAs) are valid for five years
and then may be renewed on the basis of re-evaluation of the
risk-benefit balance.
• Once renewed the marketing authorization will be valid for
an unlimited period.
• Applications for renewal should be submitted at least six
months before expiry.

16. Cancellation of License
• 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, a letter should be
sent indicating cancellation to
 Administrative support team
 MHRA has authority to cancel license of products if it
affects public health.

17. Post Marketing Surveillances and Yellow Card
Scheme
• Once the newly licensed medicine is in general use, it will be
carefully monitored for safety.
• All medicines have a Patient Information Leaflet (PIL), which gives
instruction on how the medicines should be used and on its side
effects.
• In UK, the Yellow Card Scheme is used by doctors and members of
the public to report unwanted side effects of a medicine to MHRA.
• The MHRA, the manufacturer or a medical specialist may investigate
the problem depending on how serious it is. It will be recorded to help
prevent similar incidents in future, even if it is not investigated.

18. THANK YOU