This slide cover basic aspects , regulatory body and marketing authorisation process in uk and European union.

1. Medicines and Healthcare
products Regulatory
Agency(MHRA)
By- Rishabh Agrawal
M-pharma sem-1
Roll no 19mph112
Guided by:
Dr Tejal Mehta mam

2. What are regulatory bodies
 In the present scenario, pharmaceuticals are considered as the most highly
regulated industries worldwide.
 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)

3. Continued…
 CDSCO(central drug standard control organisation) - India
 HEALTH CANADA - CANADA
 MCC(medicines control council) - South Africa
 ANVISA (Agencia national de vigilancia sanitaria) - Brazil
 EMEA (European medicines agency) - Europe
 KFDA(Korean food and drug administration) - South Korea
 MoH (Ministry of health) - Sri Lanka

4. History of MHRA
 MCA was UK licensing authority, part of the Department of Health;
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). In April 2013, 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 within the group.

5. 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

6. What MHRA is responsible for:
 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.

7. Some major role of 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

8. 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.

9. 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
patient groups or different
conditions.

10. Licensing Process
Applicat
ion of
clinical
trial
Evaluation
By
MHRA
If
satisf
ied
If not
Clini
cal
trials
Assesm
- ent
of
data
by
expert
If satisfied
market
authorization
given
If not
satisfied
license not
granted

11. Types of Market Authorization
Procedure:
 Centralized Procedure
 Decentralized Procedure
 Nationalized Procedure
 Mutual Recognition

12. Centralized Procedure:
The centralized procedure is one which allows applicants to obtain a
marketing authorization that is valid throughout the EU via single
application to EMEA.
Features:
 Results in a single authorization valid in EU.
 Application evaluated by an assigned Rapporteur.
 Timeline: EMA opinion issued within 210 days, and submitted to
European Commission for final approval.
 Required for medicine of biotechnology processes , cancer, HIV/Aids,
diabetes, orphan medicines,etc.

13. Mutual Recognition Procedure:
The Mutual Recognition procedure allows applicants to obtain a marketing
authorization in the member states(Concerned Member State) other than the member
state (Reference Member State) where the drug is previouslyapproved.
Features:
 Applicant submits identical dossier to all EU member states in which it
wants authorization, including required information.
 As soon as one Member State decides to evaluate the medicinal product
(at which point it becomes the "RMS"), it notifies this decision to other
Member States (which then become the "CMS"), to whom applications
have also been submitted.
 RMS issues a report to other states on its own findings.
 Generic industry is the major user of this type of drug approval procedure.
 This process may consume a time period of 390 days.

15. Nationalized Procedure :
 Nationalized Procedure the Nationalized procedure is one which allows
applicants to obtain a marketing authorization in one member state
only.
In order to obtain a national marketing authorization, an application must
be submitted to the competent authority of the Member State.
 New active substances which are not mandatory under Centralized
procedure can obtain marketing authorization under this procedure.
 Timeline for this procedure is 210 Days.

16. Decentralized procedure:
Using this procedure, companies may apply for authorization simultaneously in
more than one EU country for products that have not yet been authorized in any
Upcountry and essentially do not fall within the centralized procedure’s essential
drugs list.12, 13 Based on the assessment report which is prepared by the RMS &
any comments made by the CMS, MA should be granted in accordance with the
decision taken by RMS& CMS in this decentralized procedure
Features:
 Generally used for those products that has not yet received any authorization
in an EU country.
 Time require 210 days.

18. Types of application (legal basis):
 Full application - Article 8(3):
Applications for new active substances are described as 'full applications’.
 Abridged applications:
Applications for medicines containing existing active substances are described as
'abbreviated’ or ‘abridged applications’.
Existing drugs with new forms, routes and indications
Sometimes, although the drug is the same, the new product has a different
strength or pharmaceutical form or is used by a different route or for different
clinical uses.

19. Continued ..
 3) Informed consent and change of ownership applications
-10C:
 For commercial reasons companies may want to take over or duplicate a
product license held by another company. Where the first company agrees to
this 'informed consent' approach, the second company can get an exact copy
license commonly known as a 'piggy-back' license.
 Alternatively, where the ownership of the company changes hands and the
new owners need to take over the old product licenses. These applications
are called 'change of ownership' applications.

20. Renewal of license:
 New Marketing authorizations (MAs) are valid for five years and then
may be renewed on the basis of a 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.

21. Renewal of Market Approval:
Apply to
renew your
MA for 5
years
applicatio
n
submissio
n via
electronic
applicatio
n forms
(eAFs)
Re-
evaluation
by Head
of MHA
MAs for
lifetime
MAs for 5
years
It takes at least 3 months to process a renewal

22. 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 the licence, a letter should be sent
indicating the cancellation to:
 Administrative Support Team
 Medicines and Healthcare products Regulatory Agency (MHRA).
 MHRA has authority to cancel license of product if it affects public health.

23. References:
 https://www.gov.uk/guidance/renew-marketing-authorisation-for-a-human-
medicine#apply-to-renew-your-ma
 https: //www.gov.uk/topic/medicines-medical-devices-blood/marketing-
authorisations-variations-licensing
 https://www.gov.uk/topic/medicines-medical-devices-blood
 Preeti M.Singh and Vandna arora“New Drug Approval Procedure in Different
Countries: A Review”
 https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulato
ry_Agency

24. Thank You For your Kind listening