The EU Clinical Trials Directives (2001/20/EC) establishes provisions for conducting clinical trials on medicinal products in EU member states, including requirements for ethics committee approval, informed consent of subjects, and reporting of adverse events. It aims to harmonize rules across countries while maintaining patient protections. A directive requires EU states to implement its goals in their own laws but allows flexibility in how to do so. This directive regulates many aspects of clinical research in Europe.

2. EU CLINICAL TRIALS DIRECTIVES(2001/20/EC)
“Directive of the European parliament and of the council on the
approximation of the laws, regulations and administrative members
of the provision states relating to the implementation of good
clinical practice in the conduct of clinical trials on the medicinal
product of human use”

3. What is a directive?
Def: A Directive is a legal act of the European union which requires
member states to achieve a particular result without dictating the
means of achieving that result. it can be distinguished from
regulations, which are self-executing and do not require any
implementing measures.
Directives can be adopted by means of a variety of legislative procedures
depending on their subject matter.

4. ACCOUNTING &
MANAGEMENT
CONTROL
PHARMACEUTICALS
INTELLECTUAL
PROPERTY RIGHTS
FINANCE
ENERGY LIST OF EU
DIRECTIVE

5. DIRECTIVES FOR PHARMACEUTICALS
DIRECTIVE 2001/20/EC
DIRECTIVE 2001/23/EC
DIRECTIVE 2001/28/EC

6. Implementation of directive 2001/20/EC
To simplify and harmonize the administrative provisions
governing clinical trials by establishing a clear, transparent
procedure.
To facilitate the internal market of medicinal products while
at the same time maintain appropriate levels of protection for
public health.

7. Article 1: Scope
This Directive establishes specific provisions regarding the
conduct of clinical trials, including multi-centre trials, on
human subjects involving medicinal products as defined in
Article 1 of Directive 65/65/EEC, in particular relating to the
implementation of good clinical practice. This Directive
does not apply to non-interventional trials.

8. Article 2:Definitions
 clinical trial, Non intervention trial, Protocol, Subject,
Informed consent.
Article 3: Protection of clinical trials subjects
 A clinical trial may be initiated only if the Ethics Committee
and/or the competent authority comes to the conclusion that
the anticipated therapeutic and public health benefits justify
the risks and may be continued only if compliance with this
requirement is permanently monitored.

9. Article 4:Clinical trials
The informed consent of the parents or legal representative has been
obtained; consent must represent the minor's presumed will and may
be revoked at any time, without detriment to the minor;
 No incentives or financial inducements are given except
Compensation.
 Article 5:Clinical trials on incapacitated adults not able
to give informed legal consent
The person not able to give informed legal consent has received
information according to his/her capacity of understanding regarding
the trial, the risks and the benefits;

10.  Article 6:Ethics committee
 The Ethics Committee shall have a maximum of 60 days from the date
of receipt of a valid application to give its reasoned opinion to the
applicant and the competent authority in the Member State concerned.
 Article 7: Single opinion
 In case of multi centre clinical trials carried out in more than one state
single opinion shall be given for each state.
 Article 8: Detailed guidance
 Article 9: Commencement of a clinical trial
 Before commencing any clinical trial, the sponsor shall be required to
submit a valid request for authorization to the competent authority of
the Member State in which the sponsor plans to conduct the clinical
trial.

11.  Article 10:Conduct of a clinical trial
 within 90 days of the end of a clinical trial the sponsor shall notify the
competent authorities of the Member State or Member States
concerned and the Ethics Committee that the clinical trial has ended.
 Article 11:Exchange of information
 Member States in whose territory the clinical trial takes place shall
enter in a European database, accessible only to the competent
authorities of the Member States, the Agency and the Commission.
 Article 12: Suspension of the trial or infringements
 Article 13 : Manufacture and import of investigational
medicinal Products.
 Article 14 : Labelling

12.  Article 15 : Verification of compliance of investigational
medicinal products with good clinical and
manufacturing practice.
 To verify compliance with the provisions on good clinical and
manufacturing practice, Member States shall appoint inspectors to
inspect the sites concerned by any clinical trial conducted, particularly
the trial site or sites, the manufacturing site of the investigational
medicinal product, any laboratory used for analyses in the clinical trial
and/or the sponsor's premises.
 Article 16 : Notification of adverse events
 Adverse events and/or laboratory abnormalities identified in the
protocol as critical to safety evaluations shall be reported to the
sponsor according to the reporting requirements and within the time
periods specified in the protocol.

13.  Article 17: Notification of serious adverse reactions
 All other suspected serious unexpected adverse reactions shall be
reported to the competent authorities concerned and to the Ethics
Committee concerned as soon as possible but within a maximum of
fifteen days of first knowledge by the sponsor.
 Article 18 : Guidance concerning reports
 Article 19 :General provisions
 Article 20 : Adaptation to scientific and technical
progress
 Article 21 : Committee procedure
 The Commission shall be assisted by the Standing Committee on
Medicinal Products for Human Use, set up by Article 2b of Directive
75/318/EEC .

14.  Article 22 : Application
 Member States shall communicate to the Commission the text of the
provisions of national law which they adopt in the field governed by
this Directive.
 Article 23 : Entry into force
 This Directive shall enter into force on the day of its publication in the
Official Journal of the European Communities.
 Article 24 : Addressees
 This Directive is addressed to the Member States.