AN INTRODUCTION TO
EU/UK PHARMACEUTICAL
REGULATORY AFFAIRS
Clare Rosser MChem (Hons), PhD
Samantha Knight BSc (Hons)
Mandy Tyler-Mahon, MChem (Hons), PhD, MTOPRA
Jay Gandecha*, BSc (Hons), MRSC, MTOPRA
April 2023
*Main author of the presentation
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Regulatory Affairs in EU/UK Pharmaceuticals: An Overview, Slides of Physical Chemistry
A comprehensive introduction to regulatory affairs in the uk and eu pharmaceutical industry. It covers the history of medicines regulation, the formation of regulatory bodies, the marketing authorization process, quality standards, post-approval changes, and brexit's impact. It also discusses the roles of various regulatory authorities and their responsibilities.
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AN INTRODUCTION TO
EU/UK PHARMACEUTICAL
REGULATORY AFFAIRS
Clare Rosser MChem (Hons), PhD Samantha Knight BSc (Hons) Mandy Tyler-Mahon, MChem (Hons), PhD, MTOPRA Jay Gandecha,* BSc (Hons), MRSC, MTOPRA April 2023 *Main author of the presentation
Objectives
- (^) An interactive session to share an overview of regulatory
affairs in UK and EU such that you have a basic
understanding of this topic at the end of the session
- (^) See how patients experience the output of regulatory
affairs
- (^) Give you an idea of what it is like to work within regulatory
affairs in a large pharmaceutical company
- (^) Provide you with contacts in the pharma regulatory affairs
industry
- (^) Answer any questions you may have
Contents
- (^) Why we need to regulate medicines
- (^) History of medicines regulation in the UK
- (^) Formation of Regulatory Bodies in the UK
- (^) Regulatory agencies across Europe
- (^) Marketing Authorisation Process
- (^) The Dossier – Common Technical Document
- (^) Break
- (^) Quality Standards
- (^) Post approval changes
- (^) Brexit
Why do we need to regulate medicines?
- (^) Drugs are not ordinary consumers’ products. In most
instances, consumers are not in a position to make
decisions about when to use drugs , which drugs to use,
how to use them and to weigh potential benefits against risks
as no medicine is completely safe.
- (^) Professional advice from either prescribers or dispensers are
needed in making these decisions. However, even healthcare
professionals nowadays are not in capacity to take
informed decisions about all aspects of medicines without
special training and access to necessary information.
- (^) The production of medicines, their distribution and
dispensing also requires special knowledge and expertise
Brief history of UK medicines regulation
- (^) Before the middle of the nineteenth century there were no
effective controls over the sale of medicines , and only limited
progress was made in ensuring their safety and efficacy
- (^) A number of sudden deaths were reported following the
introduction of chloroform as an anaesthetic, as a result of which
a British Medical Association (BMA) working party suggested in
1880 the setting up of an independent body to assess drug
safety.
- (^) Before the Medicines Act of 1968 medicines were classified as
poisons.
- (^) A new category of dangerous drug introduced in 1920 and
therapeutic substances in 1925. Some legislation to control
the quality, sale and promotion of medicines existed before
then, but its impact was very limited.
The thalidomide disaster
- (^) The thalidomide disaster in 1961 was the major
watershed that transformed medicines regulation in the
UK. Thalidomide first went on sale in 1956 as a
sedative and hypnotic.
- (^) It was widely prescribed during the late 1950s and early
1960s for insomnia, because it was seen to be vastly
safer than barbiturates
- (^) following anecdotal reports of benefits in the treatment of
vomiting in early pregnancy , it was heavily promoted
for the relief of morning sickness in the first few months
of pregnancy.
The thalidomide disaster
- (^) But in 1959 reports started to appear of babies being born with malformed limbs and other associated internal malformations.
- (^) November 1961 a possible link between these serious birth defects and thalidomide was highlighted , as a result of which the drug was withdrawn. Within nine months or so the epidemic of malformations returned to background levels.
Regulatory bodies
- (^) Responsibility for this role initially lay with the
Medicines Division of the Department of Health for
human medicines. Rising demands and delays in
licensing led to the creation of the Medicines Control
Agency (MCA) in 1989
- (^) MCA then merged with the Medical Device Agency to
become the Medicines and Healthcare products
Regulatory Agency (MHRA) in 2003
Regulatory bodies
- (^) National Competent Authorities e.g. MHRA (UK)
- (^) The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
- (^) The MHRA also regulate Blood
- (^) It is the responsibility of the MHRA and the expert advisory bodies set up by the Medicines Act to ensure that the sometimes difficult balance between safety and effectiveness is achieved.
- (^) MHRA experts assess all applications for new medicines to ensure they meet the required standards. This is followed up by a system of inspection and testing which continues throughout the lifetime of the medicine.
- (^) Safety monitoring is also continuous and the MHRA also ensures that doctors and patients receive up-to-date and accurate information about their medicines. This is achieved by ensuring that product labels, leaflets, prescribing information and advertising meets the required standards laid down by the Regulations.
Regulatory Agencies
- (^) The HMA: Head of Medicines Agencies
- (^) The Heads of Medicines Agencies (HMA) is a network of the heads of
the National Competent Authorities (NCA) whose organisations are
responsible for the regulation of medicinal products for human and
veterinary use in the European Economic Area.
- (^) The HMA co-operates with the European Medicines Agency (EMA)
and the European Commission in the operation of the European
medicines regulatory network and it is a unique model for cooperation
on statutory as well as voluntary regulatory activities.
- (^) The HMA:
- (^) addresses key strategic issues for the network, such as the exchange of information, IT developments and sharing of best practices
- (^) focuses on the development, co-ordination and consistency of the European medicines regulatory system
- (^) ensures the most effective and efficient use of resources across the network. This includes developing and overseeing arrangements for work-sharing
- (^) co-ordinates the mutual recognition (MRP) and decentralised procedures (DCP).
EU Member states
Principle responsibilities of regulatory authorities
- (^) Licensing of the manufacture, import, export, distribution,
promotion and advertising of medicines
- (^) Assessing the safety, efficacy and quality of medicines, and
issuing marketing authorisation for individual products
- (^) Inspecting and surveillance of manufacturers, importers,
wholesalers and dispensers of medicines
- (^) Controlling and monitoring the quality of medicines on the
market
- (^) Controlling promotion and advertising of medicines
- (^) Monitoring safety of marketed medicines including collecting
and analysing adverse reaction reports
- (^) Providing independent information on medicines to
professionals and the public
The story so far…
Medicines regulation Regulatory Agencies National Agencies Pharmaceutical Companies