NIS Considerations
CHCUK NewsletterJanuary 2011
In this Month's Issue
France: Proposed NIS Regulations Loom Closer
Latvia: Regulation 289 (2010)
Spain: 2010 Code of Practice
EMA & ENCePP Launch E-Register
ICH: New Website
Cyprus: Code of Practice
Turkey: 2010 Code of Practice
Switzerland: 2010 Code of Practice
CHCUK: New NIS Training Slides
Advertising Opportunity: NIS Report - Europe Part 2
CHCUK: Bespoke NIS Reports




Happy New Year!

CHCUK would like to wish you a prosperous and peaceful 2011.

As you will see from this first newsletter fo 2011, this year promises to be a year of change and opportunity as the non-interventional study research environment continues to evolve and blossom.

Best wishes,
Happy New Year (2011)

Stuart McCully
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
France: Proposed NIS Regulations Loom Closer
A new Bill of Law (Recherches sur la Personne) Aims at Harmonising the Regime of Interventional and Non-Interventional Clinical Trials. 
Flag of France


 A Bill of Law entitled « Recherches sur la personne » (« Researches on person ») was filed with the French Parliament (« Assemblée Nationale ») on 6 January 2009. The French Parliament adopted the Bill on 22 January 2009.


The Bill of Law notably aims at harmonizing the regime of interventional and non-interventional clinical trials. Currently, non-interventional studies are not considered as clinical trials and are not regulated by the provisions of the French Public Health Code on clinical trials.


According to the Bill of Law, non-interventional studies will now require the information of the patients which can refuse to participate in a non-interventional study.  Moreover, the

sponsor will have to obtain the prior approval of the non-interventional clinical trial by the competent Ethic Committee. Finally, Good Clinical Practices for non-interventional clinical trials will be adopted.


Since 29 October 2009, the Bill of Law has been under discussion before the French Senate.


The new Bill of law modified by the French Senate in a second lecture was filed on 20 December 2010 and is now available (in French) since 5 January 2011.


A commission between members of the French Parliament and of the French Senate is now in charge of making proposals regarding what is still under discussion.


Acknowledgements: Paule Drouault-Gardrat, PDG Avocats, Paris

Latvia: Regulation 289 (2010)
NIS in Latvia are Now Governed by Cabinet Regulation 289 (2010)

Latvian FlagThe conduct of Non-interventional Studies in now governed by Cabinet Regulation No. 289 (2010) "Regulations on Conducting Clinical Trials and Non-interventional studies and Labelling of Investigational Medicinal Products, and Procedure for Conducting Inspections on Compliance with the Requirements of Good Clinical Practice"

Articles 128 to 135 deal specifically with Non-interventional studies

These regulations replace the Regulations on Conducting Clinical Trials and Non-interventional studies and Labelling of Investigational Medicinal Products, and Procedure for Conducting Inspections on Compliance with the Requirements of Good Clinical Practice (Regulation No.172 of 28th February 2006) which were amended in 2008.

Spain: 2010 Code of Practice
Farmaindustria Releases New Code of Practice
2010 Spanish COP
In October 2010, Farmaindutria released a new Spanish Code of Good Practices
for the Promotion of
Medicines and Interaction
with Healthcare Professionals which captures the recent changes to Spanish law (2010 Farmaindustria COP).

Section 14 specifically deals with the requirements for:
  • Clinical Trials
  • Post-Authorization Studies
  • Market Research Studies

In accordance with Section 14.2 "Post-authorization observation studies shall be those epidemiological studies that meet the conditions of being post-authorization and observational. These must be conducted in accordance with the requirements of applicable legislation, among others, submission of the documentation to the AEMPS for registration and classifi cation, submission to a Clinical Research Ethics Committee for evaluation, etc. These studies should in no case be undertaken as a procedure to promote a product or to induce prescription by healthcare professionals."

Refer to:

EMA & ENCePP Launch E-Register
European Medicines Agency and European Network if Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have Launched an Electronic Register of Studies (E-Register).


The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have launched the ENCePP E-Register of Studies. This electronic register is a publicly accessible resource for the consultation of pharmaco-epidemiological and pharmacovigilance studies conducted by academic centres and other research organisations.


The purpose of the E-Register is to increase the availability of information on the utilisation, safety and effectiveness of medicines used in clinical practice through a readily accessible database resource.


It will also contribute to reducing publication bias by handling both positive and negative study results in the same manner and promote exchange of information, thereby facilitating collaboration within the scientific community and preventing unnecessary duplication of research.


Registration of studies in the register is voluntary, except for those studies wishing to apply for the status of 'ENCePP Studies', a seal awarded to wholly or partially EU-based, benefit/risk studies that are carried out in compliance with the ENCePP Code of Conduct for independence and transparency and the ENCePP Checklist of Methodological Research Standards. Studies that potentially qualify for this seal must be entered into the E-Register before they commence.


The E-Register of studies can be accessed through the ENCePP website.


For all studies included in the E-Register, investigators are required to regularly update the information that is available in the register.


The launch of the E-Register of Studies is the latest milestone achieved by ENCePP, following the adoption of the ENCePP Code of Conduct, the launch for public consultation of the Guide on Methodological Standards for pharmacoepidemiological studies and the launch of an inventory of resources. The ENCePP project, which is led by the European Medicines Agency, is intended to enhance the way medicines are monitored once they have been approved for use in the European Union by facilitating the conduct of high quality, multi-centre, independent, post-authorisation studies.


Source: EMA Press Release (25/11/2010)  


Acknowledgements: Professor David Hutchinson of Canary Ltd and Brookwood Academy 

ICH: New Website
The ICH website has Recently Received a Face Lift
New ICH Website
The ICH website has recently received a facelift.  This is great news for all BUT it does mean that any favourites and hyperlinks you may have had to the ICH Guidelines now need to be updated as they will no longer work.

We are currently in the process of updating all of our resources so please bear with us.

Cyprus: Code of Practice
Considerations for Carrying Out NIS in Cyprus
Flag of Cyprus
According to Article 22 of Code of Practice of The Cyprus Association of Research based Companies (KEFEA COP), collaboration between the pharmaceutical industry and physicians in carrying out clinical trials, pharmaco - epidemiological and pharmaco - genetic trials are of crucial importance for the development of medicinal products, for thorough knowledge of their properties and for their best use to the interest of the patients.

In all clinical trials, the following principles must be applied:
  1. All persons participating in a clinical trial must respect the ethical and professional principles and guidelines such as the Helsinki Declaration and the ICH guidelines for Good Clinical Practice
  2. The purpose of the trial must always be the improvement of therapeutic, diagnostic methods and / or medical knowledge to the best interest of patients.
  3. A trial must not be performed in view of increasing sales or prescribing.
  4. The purpose of the trial must be declared in advance. The trial protocols must be compiled in such a way as to ensure success of the aim of the trial and that valid conclusions are drawn.
  5. All kinds of clinical trials are carried out only upon approval by the competent authorities (Drugs' Council) or / and the BIO Ethics Committee.
  6. The sponsor must be known to patients participating in the trial.
  7. The physician must not receive any remuneration or compensation for the mere inclusion of patients in clinical trials.
  8. The physician may receive remuneration for his / her work in the trial. Remuneration must be given in connection with the work provided and must be declared to the National BIO Ethics Committee the management of the organisation that he or she belongs and the Drugs' Council, who supervise the trial. Remuneration must not be connected with the expected outcome of the trial.
  9. i) Remuneration shall be effected in accordance with the applicable law.
  10. j) All data on safety and efficacy with respect to marketed products must be truthfully published on the internet irrespective of the outcome of the trial, at least in summary, within the year following the grant of the marketing authorisation. Furthermore, other important clinical results must be published in the same way.
  11. In publications, lectures and other presentations, the identity of the sponsor must be known.
  12. The physician may receive remuneration for lectures relating to the clinical trial and the results thereof.
  13. When presenting clinical trials, the physician must make known his connections with all the companies of the therapeutic area covered by his lecture.

For further information, refer to the KEFEA COP (2009)

Turkey: 2010 Code of Practice
AIFD Updated it's Code of Practice in 2010
Flag of Turkey
TheTurkish Association of Research-Based Pharmaceutical Companies (AİFD) updated it's Code of Practice in 2010.

Article 17 provides comprehensive guidance on "Non-interventional Studies of Marketed Medicines"

For more details refer to the:

Switzerland: 2010 Code of Practice
The SGCI Updated their Code of Pratice in 2010

The SGCI released a new Code of Practice in September 2010.  No changes have been made to Section 37 which deals with "Non-interventional studies using authorized medicinal products"

For further information refer to the:
  • 2010 Code of Conduct of Pharmaceutical Industry in Switzerland (Pharma Code)

CHCUK: New NIS Training Slides
CHCUK has Uploaded some Complimentary Generic NIS Training Slides
NIS Training Slides

We have uploaded some complimentary NIS Training slides which are now available for download via our website. 

The slide set is focused towards the NIS research environment in the UK and is also a reflection of the "Non-CTIMP" requirements for the UK.

CHCUK services include the development of training material, as well as the provision of training.  Feel free to contact us if this would be of interest.

Telephone: +44 1997 42 33 11

Advertising Opportunity: NIS Report - Europe Part 2
Part 2 of the NIS (Europe) Report is now being Updated
CHCUK Service Providers
Part 2 of our series of reports on NIS in Europe is now due for revision and will be provded free of charge, once revised, to any clients who have previously purchased the report.

If any clients wish to advertise their services within the report, you will be pleased to know that we are adding a new ""SERVICE PROVIDERS" section to each of the country sub-sections to aid readers in finding country-specific service providers.  Further information can be found in our "Information for Advertisers " document.

The prices listed below are inclusive of an advert placed in all 17 country-specific sections:
  • Text only entry: £75
  • Full A4 graphical advert: £250
  • Half A4 graphical Advert: £125
If you would like to take advantage of this opportunity, please note your interest by 28 February 2011.

Telephone: +44 1997 42 33 11

CHCUK: Bespoke NIS Reports
CHCUK Develops Bespoke 'NIS Considerations' Reports Based on Client Needs
Bespoke NIS Reports
You may not be aware that one of the many services we provide to clients includes the development of bespoke reports which capture the  considerations for conductingNIS in countries and continents throughout the world.

Bespoke Reports Recently Created for Clients Cover the Considerations for Conducting NIS is the Following Geograohic Areas:
  • South Africa
  • Russia
  • Latin America
If you are interested in any of these existing reports or would like to speak to us about any other areas please do not hesitate to contact me:

Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510