The document summarizes the regulatory requirements of the European Union (EU) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The EU established the European Medicines Agency (EMA) which is responsible for scientific evaluation and safety monitoring of medicines. EMA grants marketing authorization after assessment and plays an important role in regulating medicines across EU. The MHRA regulates medicines and medical devices in the UK to ensure safety, quality and efficacy. It oversees clinical trials, manufacturing licensing, and post-marketing surveillance.

1. REGULATORY REQUIREMENTS OF
EU & MHRA
Presented by :
Trilok D. Shahare
M.Pharm 1st Semester
Dept. of Pharmaceutics
D.B.C.O.P. Besa, Nagpur
Guided by :
Miss. Shilpa A. Pise
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2. European Union : (EU)
 A regulation is a legal act of the European Union that become
immediately enforceable as law in all member states
simultaneously.
 The role of regulatory authorities is to ensure the quality,
safety, and efficacy of all medicines in circulation in their
Country.
 It not only includes the process of regulating and monitoring the
drug but also the process of manufacturing, distribution, and
promotion of it.
 Established under the name in 1992 by the treaty on European
Union (the Maastricht union).
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3. European Medicines Agency (EMA) is a decentralized agency of the
European union.
EMA protects public and animal health by ensuring that all medicines
available on the EU market are safe, effective and of high quality.
The agency is responsible for the scientific evaluation, supervision and
safety monitoring of the medicines developed by pharmaceutical
companies for the use in EU.
EMA and the member states cooperate and share expertise in the
assessment of new medicines and of new safety information.
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4. Market Authorization :
 To protect public health and ensure the availability of high
quality, safe and effective medicines for European citizens, all
medicines must be authorized before they can be place in the
market in EU.
 The agency’s Committee for medicinal product for Human use
(CHMP) or Committee for medicinal product for veterinary use
(CVMP) carries out a scientific assessment of the application and
give a recommendation to the European Commission on whether or
not to grant a marketing authorization.
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5. EMA play an imp. Role in regulation of medicines in the EU. On the basis of
scientific assessments carried out, it grants or refuse, changes or suspends
marketing authorization for medicines that have been submitted via the
centralized procedure.
The European commission can also take action concerning other aspects of
medicine regulation.
 Right of initiative : it can propose new or amended legislation for the
pharmaceutical sector.
 Implementation : it can adopt implementing measures as well as oversee the
correct application of EU law on pharmaceutical.
 Global outreach : it ensures appropriate collaboration with relevant
international partners and promotes the EU regulatory system globally.
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6. Guidelines And Scientific Advice :
 EMA prepares scientific guidelines in cooperation with experts from its
scientific committee and working groups.
 These guideline reflect the latest thinking on developments in
biomedical science.
 They are available to guide the development programmes of all
medicine developers who wise to submit an application for a marketing
authorisation in the EU, and to ensure that medicines are developed
consistently and to the highest quality.
 EMA also gives product-specific scientific advice to companies for the
development of medicines.
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7. Authorization And Supervision Of
Manufacturers :
 Manufacturers, importers and distributors of medicines in the EU must be
Licensed before they can carry out those activities.
 The regulatory authorities of each Member State are responsible for
granting licences for such activities taking place within their respective
territories.
 Manufacturers listed in the application of a medicines to be marketed in the
EU are inspected by an EU competent authority.
 Inspection out come can be accessed by all Member States and are made
publicly available across the EU through EudraGMDP.
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8. Safety Monitoring Of Medicines
 The European regulatory system for medicines monitors the safety of all
medicines that are available on the European market throughout their
life span.
 All suspected side effects that are reported by patients and healthcare
professional must be entered into EudraVigilance, the EU web-based
information system operated by EMA that collects, manages and
analysis reports of suspected side effects of medicines.
 These data are continuously monitored by EMA and the Member
States in order to identify any new safety information.
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9. MHRA :
 What is MHRA ?
The Medicines and Healthcare products Regulatory Agency (MHRA) is an
executive agency of the Department of health of United Kingdom.
The MHRA was set up in April 2003 to bring together the functions of the
Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The MHRA is responsible for ensuring that medicines and medical devices
work, and are acceptably safe.
MCA
MDA
MHRA
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10. Function of MHRA
The MHRA has no interest in these early stage of drug development.
 Performulation and laboratory tests.
 Drug discovery
 Mechanism of action
MHRA comes in play when the company wants to start clinical trials in
patients.
 Clinical trials
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11. Function of MHRA :
 Regulation of clinical trials
 Safety and efficacy monitoring
 Providing information to public and health professionals
 Enforcement of law
 Licensing
 Manufacturer and dealer licenses
 Clinical trial licenses
 Parallel import licenses
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12. Aims of MHRA :
 Protection – public health through regulation, with
acceptable benefit-risk profiles for medicines and devices.
 Promoting – public health by helping people who use
these products to understanding their risks and benefits.
 Improving – public health by encouraging and facilitating
developments in products that will benefit people.
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13. Objectives of MHRA :
 Safeguard public health through MHRA’s primary role in ensuring
that products MHRA regulate meet required standards, that they work
and are acceptable safe.
 Carry out communication role through the provision of accurate,
timely and authoritative information to healthcare professionals,
patients and the public.
 Support research, ensuring through the application of Better
Regulation principle that regulation does not stifle innovation.
 Influence the shape of the future regulatory framework through use of
our effective European and International relationship.
 Run an organisation with a skilled and equipped workforce that is fit
for the future.
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14. The MHRA’s activity :
 Assessing the safety, quality and efficacy of medicines, and
authorising their sale or supply in the UK for human use.
 Overseeing the UK Notified Bodies that audit medical device
manufacturers.
 Operating post-marketing surveillance and other system for
reporting, investigating and monitoring adverse reactions to medicines
and adverse incidents involving medical devices.
 Regulating clinical trails of medicines and medical devices.
 Monitoring and ensuring medicines and medical devices.
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15.  Promoting good practice in the safe use of medicines and
medical devices.
 Managing the General Practice Research Database (GPRD) and
the British Pharmacopoeia (BP) and contributing to the
development of performance standards for medical devices.
 Offering scientific, technical and regulatory advices on medicines
and medical devices.
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16. What MHRA regulates ?
 Medicine
 Licencing medicines
 Medicines for children
 Inspection and Standards
 Importing and exporting medicines
 Best practice guidance on labelling and packaging
of medicines
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17. The role of MHRA :
 Assess application for marketing medicinal products.
 Assess application to undertaken clinical trials.
 Inspect the manufacturers and wholesalers of medicines-
licensing.
 Undertaken post-marketing surveillance including :
 Pharmacovigilance
 Quality defect monitoring
 Sampling and testing
 Product recalls
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18. References :
• http://www.mhra.gov.uk
• http://www.Europa.eu/European-union/index en
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