REGULATORY BODIES IN EUROPE

8/7/2019 REGULATORY BODIES IN EUROPE

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Regulatory Body in

Europe

Rahul Khare


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Why Regulatory Bodies ???

Regulatory requirements describe what isnecessary for a new drug to be approved formarketing in any particular country.


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EU Clinical Trials Directive

The European Clinical Trials Directive 2001/20/EC (EUCTD)was introduced to establish standardisation of researchactivity 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 clinicaltrials on medicinal products for human use'', and is aimed atthe regulation of clinical trials within the European Union

and was transposed by each EU country into its own law


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The EUCTD was transposed into UK law as the Medicines for Human Use (Clinical Trials) Regulations 2004 which cameinto 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 inhumans .


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The Clinical Trials Regulations 2004include additional controls.

Establishment of ethics committees on a legal basis.

Each Clinical Trial must have an identified Sponsor whotakes responsibility for its initiation, conduct andmanagement.

Phase 1 pharmacology studies in healthy volunteers require authorisation by the Medicines and Healthcare productsRegulatory Agency (MHRA).


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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 inspectionsof the sponsor, researchers, facilities and manufacturing

organisations for GCP, GMP and pharmacovigilance to helpensure required standards are maintained.


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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 Manufa

cturing Practice (GMP).

Reporting of Serious Adverse Events (SAE's).


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Protection of clinical trial subjects

Articles 3, 4 and 5 of the directive pay special attention tothe protection of clinical trial subjects and informed consent.

The Directive requires all trial subjects, or the personse legal representativef if the subject is not able, to giveinformed consent.

Also, there is a requirement to ensure that the minor hasreceived adequate information according to his/her capabilityand understanding.


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Ethic Committees

Articles 6 and 7 of the CT Directive define the proceduresfor Ethics Committees, including a time limit for decisions.

The Ethics Committee will play a key role at the very earlystages 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 theclinical trial and the clinical trial design; the protocol; thesuitability of the investigator and supporting staff; theinvestigators brochure and the quality of facilities.


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Ethics Committee Cont...

There is a provision in the Directive that allows a MemberState to refer questions directly to the regulatory authorityresponsible for regulating clinical trials in each Member State


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Timelines

CT Directive timelines for the assessment of Clinical Trialapplications .

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 30days.

Products that require external consultation - additional 90days.

Xenogenic cell therapy - no time limit.


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Following commencement of the clinical trial the sponsor isable to make amendments to the protocol but the sponsormust 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 theregulatory body must form an opinion on the proposedamendments within a maximum of 35 days.


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It also requires the sponsor to provide a report to the MCAand Ethics Committee at the end of the trial within 90 daysof completion.

If the trial has to be terminated early this notification periodis reduced to 15 days and a reason for termination must be

provided.


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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 adverseevents reported to the MCA.

These details will go into a European database, which is

supported by the European Agency for the Evaluation ofMedicinal Products (EMEA).All CT information will be recorded to this database, allowing exchange of information between all Member in particular safety alerts and refusal ofauthorisation. This database will only be accessible to the

regulatory authorities of the States of the EU.


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GCP & GMP

Article 13 of the CT Directive states all manufacturers ofinvestigational medicinal products (IMPs), including placebosand active comparator products, require a manufacturers

license.

That is all IMPs must be manufactured to Good Manufacturi

ng Practice (GMP) . If the IMP is manufactured outside theEU it is the responsibility of the ''Qualified Person'' QP toensure the product has been manufactured according to GMP.


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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 threateningto be reported to the regulatory authority and to the EthicsCommittee within 7 days of the sponsors'' knowledge, additi

oninformation should be provided within a further 8 days.

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


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THANK YOU

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REGULATORY BODIES IN EUROPE