Regulatory Bodies in Europe

Regulatory Body in
Europe
Rahul Khare
Why Regulatory Bodies ???
 Regulatory requirements describe what is

necessary for a new drug to be approved for
marketing in any particular country.
EU Clinical Trials Directive
 The European Clinical Trials Directive 2001/20/EC (EUCTD)

was introduced to establish standardisation of research
activity in clinical trials throughout the European Community.
 In May 2001, the current EU Directive was published on the

conduct of clinical trials in Europe.
 The EU Directive (2001/20/EC) relates "to the implementation

of good clinical practice (GCP) in the conduct of clinical trials
on medicinal products for human use'', and is aimed at the
regulation of clinical trials within the European Union and
was transposed by each EU country into its own law.
 The EUCTD was transposed into UK law as the Medicines for
Human Use (Clinical Trials) Regulations 2004 which came into
force on 1st May 2004.
 The European Union Clinical Trials Directive (2001/20/EC)

provides a framework which sets out how clinical trials
investigating the safety or efficacy of a medicinal product in
humans .
The Clinical Trials Regulations 2004
include additional controls.
 Establishment of ethics committees on a legal basis.
 Each Clinical Trial must have an identified Sponsor who

takes responsibility for its initiation, conduct and
management.
 Phase 1 pharmacology studies in healthy volunteers require

authorisation by the Medicines and Healthcare products
Regulatory Agency (MHRA).
Cont...
 Investigational medicinal products (IMPs) must be

manufactured to Good Manufacturing Practice (GMP)
standards and the manufacturer must have a manufacturing
licence.
 The MHRA is empowered to carry out statutory inspections of

the sponsor, researchers, facilities and manufacturing
organisations for GCP, GMP and pharmacovigilance to help
ensure required standards are maintained.
Aims of CT Directives
 Protection of clinical trial subjects.
 Procedures for Ethics Committees.
 Exchange of information between the regulatory bodies and the European Medicines
Agency (EMA).
 Standards for Good Clinical Practice (GCP) & Good Manufacturing Practice (GMP).
 Reporting of Serious Adverse Events (SAE's).

Protection of clinical trial subjects
• Articles 3, 4 and 5 of the directive pay special attention to the

protection of clinical trial subjects and informed consent.
• The Directive requires all trial subjects, or the persons

“legal representative” if the subject is not able, to give
informed consent.
• Also, there is a requirement to ensure that the minor has

received adequate information according to his/her capability
and understanding.
Ethic Committees
• Articles 6 and 7 of the CT Directive define the procedures for

Ethics Committees, including a time limit for decisions.
• The Ethics Committee will play a key role at the very early
stages of the trial in the document evaluation process.
• The Directive states the responsibilities of the Ethics

Committees that involves the opinion on the relevance of the
clinical trial and the clinical trial design; the protocol; the
suitability of the investigator and supporting staff; the
investigators brochure and the quality of facilities.
Ethics Committee Cont...
• There is a provision in the Directive that allows a Member

State to refer questions directly to the regulatory authority
responsible for regulating clinical trials in each Member State
Timelines
CT Directive timelines for the assessment of Clinical Trial

applications .
 60 days for Medicine Control Agency (MCA) and the Ethics
Committee.
The 60 day time period can be extended in following :

 Gene therapy or somatic cell therapy or medicinal products
containing genetically modified organisms - additional 30
days.
 Products that require external consultation - additional 90
days.
 Xenogenic cell therapy - no time limit.
 Following commencement of the clinical trial the sponsor is

able to make amendments to the protocol but the sponsor
must notify the MCA of the reasons for, and the content of,
these amendments. The sponsor must also inform the Ethics
Committees concerned. The Ethics Committee and the
regulatory body must form an opinion on the proposed
amendments within a maximum of 35 days.
 It also requires the sponsor to provide a report to the MCA

and Ethics Committee at the end of the trial within 90 days of
completion.
 If the trial has to be terminated early this notification period is

reduced to 15 days and a reason for termination must be
provided.
Exchange of Information
 Article 11 of the Directive allows the exchange of clinical trial

information across Europe.
 A European safety database will be set up for all adverse

events reported to the MCA.
 These details will go into a European database, which is

supported by the European Agency for the Evaluation of
Medicinal Products (EMEA).All CT information will be
recorded to this database, allowing exchange of information
between all Member in particular safety alerts and refusal of
authorisation. This database will only be accessible to the
regulatory authorities of the States of the EU.
GCP & GMP
 Article 13 of the CT Directive states all manufacturers of

investigational medicinal products (IMPs), including placebos
and active comparator products, require a manufacturers
license.
 That is all IMPs must be manufactured to Good

Manufacturing Practice (GMP) . If the IMP is manufactured
outside the EU it is the responsibility of the ''Qualified
Person'' QP to ensure the product has been manufactured
according to GMP.
Adverse Events
 Article 17 of the Directive requires notification for all serious

adverse events.
 As per ICH guidelines, Directive requires all unexpected serious

adverse events (SAEs) that are fatal or life threatening to be
reported to the regulatory authority and to the Ethics
Committee within 7 days of the sponsors'' knowledge,
additioninformation should be provided within a further 8 days.
 Other SAEs must be reported within 15 days of the sponsors''

knowledge.
THANK YOU

Regulatory Bodies in Europe

Uploaded by

Copyright:

Available Formats

Regulatory Bodies in Europe

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Regulatory Bodies in Europe

Uploaded by

Copyright:

Available Formats

Regulatory Body in

 Regulatory requirements describe what is

 The European Clinical Trials Directive 2001/20/EC (EUCTD)

 In May 2001, the current EU Directive was published on the

 The EU Directive (2001/20/EC) relates "to the implementation

 The European Union Clinical Trials Directive (2001/20/EC)

 Establishment of ethics committees on a legal basis.

 Each Clinical Trial must have an identified Sponsor who

 Phase 1 pharmacology studies in healthy volunteers require

 Investigational medicinal products (IMPs) must be

 The MHRA is empowered to carry out statutory inspections of

 Protection of clinical trial subjects.

 Procedures for Ethics Committees.

 Reporting of Serious Adverse Events (SAE's).

• Articles 3, 4 and 5 of the directive pay special attention to the

• The Directive requires all trial subjects, or the persons

• Also, there is a requirement to ensure that the minor has

• Articles 6 and 7 of the CT Directive define the procedures for

• The Directive states the responsibilities of the Ethics

• There is a provision in the Directive that allows a Member

CT Directive timelines for the assessment of Clinical Trial

The 60 day time period can be extended in following :

 Following commencement of the clinical trial the sponsor is

 It also requires the sponsor to provide a report to the MCA

 If the trial has to be terminated early this notification period is

 Article 11 of the Directive allows the exchange of clinical trial

 A European safety database will be set up for all adverse

 These details will go into a European database, which is

 Article 13 of the CT Directive states all manufacturers of

 That is all IMPs must be manufactured to Good

 Article 17 of the Directive requires notification for all serious

 As per ICH guidelines, Directive requires all unexpected serious

 Other SAEs must be reported within 15 days of the sponsors''

You might also like

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.