CHCUK

May 2014
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In this Month's Issue
CHCUK: Why Wait for NIS News When You Can Get it Live?!.
EU: EMA Releases Guidance on Parallel Advice with HTAs
EU: Revision 3 of EMA Guideline on Good Pharmacovigilance Practices (GVP): Annex I
U: Revision 1 of EMA GVP Module XVI Published on 25 April 2014
EU: Revision 1 of EMA GVP Module V Published on 25 April 2014
U: Regulation Regarding Post-Authorisation Efficacy Studies
CHCUK: 2014 Update to the NIS Considerations - Australia
CHCUK: 2014 Update to NIS Considerations - France
UK: MHRA Guidance on Medical Device Stand-Alone Software - Including Apps
EU: EMA Launches Pilot Early Access Program
EU: European Medicines Agency Publishes First Summary of a Risk-Management Plan
Russia: New Requirements for HCOs who Conduct Clinical Trials
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Summary of NIS Requirements for Europe
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CHCUK: Free NIS Resources
  Greetings!

I often talk about the 'complex simplicity' of non-international studies.  What do I mean by this?  By design, these are relatively simple studies, but operationalising them is complicated by the lack of legislative harmonisation across the globe.  Every country regulates the conduct of non-interventional studies differently.

Non-Interventional Study or "Low-Intervention Clinical Trial"?

The implementation of the revised pharmacovigilance legislation in Europe in July 2012 has had a significant impact on the conduct on NIS.  Have you considered what impact the new European Clinical Trials Regulations will have on NIS when the come into force in 2016?

Article 1 of the new regulation states that "It shall not apply to non-interventional studies", which is inline with Directive 2001/20/EC that it repeals in 2016.

However, from 2016, a non-interventional study will be defined as a "clinical study other than a clinical trial" and a 'Low-intervention clinical trial' is defined as a "clinical trial which fulfils all of the following criteria
  1. The investigational medicinal products are authoirsed
  2. according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of their marketing authorisation or their use is a standard treatment in any of the member states concerned
  3. The additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in an Member states
So, under these proposed definitions would your current NIS still be defined as an 'NIS' or a 'Low-intervention clinical trial'?  Food for thought!

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Best wishes,

Stuart McCully
CHCUK
 
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CHCUK: Why Wait for NIS News When You Can Get it Live?!
CHCUK Introduces a new free 'NIS Considerations" app for all platforms

It seemed mad to wait 2 months for our 'NIS Considerations' newsletter, so we've developed a new FREE app for all smartphone that provides you with live NIS news updates (from our updated website).

Just search for "NIS Considerations" on the applicable app store.

The 'NIS Considerations' app is live on the Android and iPhone stores and have been submitted to the Windows and Blackberry stores, so should be live for the latter two platforms any time soon.
 
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EU: EMA Releases Best Practice Guidance on Parallel Scientific Advice with Health-Technology-Assessment Bodies
Guidance to facilitate early dialogue between regulators, health-technology-assessment bodies and medicines developers
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The European Medicines Agency (EMA) has published today for public consultation best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies.

 

The document is a key outcome of the EMA-HTA workshop on parallel scientific advice, which took place in November 2013 and brought together over 280 representatives from, among others, the European Commission, European regulators, HTA bodies, the European Network for Health Technology Assessment (EUnetHTA), the pharmaceutical industry, payers, patients and healthcare professionals. The report of the workshop was also published on the 14th May 2014.

 

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EU: Revision 3 of EMA Guideline on Good Pharmacovigilance Practices (GVP): Annex I - Definitions Updated on 25 April 2014

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Revision 3 of EMA Guideline on Good Pharmacovigilance Practices (GVP): Annex I - Definitions was updated on the 25 April 2014
Revision 3 includes the following:
  • Amendments of definitions of Missing information (including its explanatory note) and Risk minimisation activity in accordance with revision 1 of GVP Module V
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EU: Revision 1 of EMA GVP Module XVI Published on 25 April 2014

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Revision 1 of EMA GVP Module XVI on risk minimisation measures was published on 25 April 2014.

Revision 1 includes the following: Amendment on page 3 to update the definition of Risk minimisation measure in accordance with revision 1 of GVP Module V   on risk management system.

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EU: Revision 1 of EMA GVP Module V Published on 25 April 2014

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Revision 1 of EMA GVP Module V on risk management system was published on 25 April 2014, mainly to amend the requirements of part VI of the RMP as published already in the updated RMP templates, to introduce amendments in line with the new requirements for variation applications and to align the definitions of Missing information and Safety concern and their explanatory notes with legal requirements, as well as to amend the definition for Risk minimisation activity.

 

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EU: Regulation Regarding Post-Authorisation Efficacy Studies

Delegated Regulation EU/357/2014 of 3 February 2014  was published in the official journal on the 10 April 2014 and will become effective on the 30 April 2014 

  

Delegated Regulation EU/357/2014 of 3 February 2014 Supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as Regards Situations in Which Post-Authorisation Efficacy Studies May be Required. Commission Delegated Regulation (EU) was published in the official journal on the 10 April 2014 and will become effective on the 30 April 2014 

 

The new pharmacovigilance legislation refers to the possibility of requesting a marketing authorisation holder to conduct post-authorisation efficacy studies (PAESs), complementing efficacy data available at the time of the initial authorisation5. To determine situations in which such studies may be required, the Commission is authorised to adopt, by means of a delegated act, measures supplementing the provisions of Directive 2001/83/EC and Regulation (EC) No 726/2004.

 

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CHCUK: 2014 Update to the NIS Considerations - Australia
2014 Update to the NIS Considerations for Australia Now Available

Both the elearning module and the detailed country-specific report for the Australian NIS considerations have been updated.  So what's changed? 

 

Medicines Australia Code of Conduct Guidelines Updated in Feb 2014

 

The Code of Conduct Guidelines now reflect and provide guidance on the 17th Edition of the Medicines Australia Code of Conduct, which became effective in January 2013

 

HCP Consultant Reports to be Submitted by 30 April 2014

 

Member companies are required to report all consultancies with healthcare professionals as defined in Section 9.8 of the Code. Set out below are examples of the consultancies which must be reported. This list is not exhaustive.

  • Developing and/or presenting a submission to PBAC or PBS.
  • Developing a continuing education program.
  • Writing or reviewing a scientific paper, promotional or educational material.
  • Expert opinion provided by one or more healthcare professionals on an ad hoc basis.
  • Independent grant review committee.
  • Market research where the company has selected the healthcare professionals participating in the research.

 

The first annual report of healthcare professional consultants must be submitted to Medicines Australia by 30 April 2014 and cover activities commenced on or after 1 January 2013 or ongoing on that date. Thereafter, the report must be provided to Medicines Australia on an annual basis by 30 April each year covering the previous calendar year.


NIS Considerations - Australia (2014)

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CHCUK: 2014 Update to NIS Considerations - France
2014 Update to the NIS Considerations for France Now Available

Both the  elearning module and the detailed country-specific report for the NIS considerations have been updated.  So what's changed? 

 

Updated Pharmacovigilance Legislation

Decree No 2012-1244 of November 8, 2012 relating to the strengthening of the safety provisions of medicinal products for human use subject to market authorization and pharmacovigilance

 

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Transparency of Relations Between Life Science Industry/ Manufacturers of Products Intended for Human Use and Health Professionals 

According to the provisions of  article L.1453-1 CSP, pharmaceutical companies must now disclose the existence of agreements that they concluded with:

  • Healthcare professionals, Associations of healthcare professionals, Students in medicine and odontology, Associations of patients, Health establishments, Foundations, Press organs for health professionals for all media (press, radio, TV or online communication), Medical prescription and deliverance software editors, Learned societies.
  • Each company must disclose the information for each agreement concluded.
  • Above a limit of 10 euros all taxes includes, the obligation of disclosure also applies to the advantages in nature or in money granted directly or indirectly by pharmaceutical companies to the above listed recipients. Consequently, all advantages granted to persons listed above that are above 10 euros will have to be disclosed.
  • The said information will be disclosed in French on a unique public website held by an authority to be created by an order of the Ministry of Health.

 

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Requirements Regarding the Summary of Product Characteristics (SmPC)

The summary of product characteristics (SmPC) should now (as per Decree No. 2012-1244):

  • Feature standard text, expressly asking patients to report suspected adverse reactions to their physician, pharmacist or other healthcare professional or directly to the Regional Pharmacovigilance Centre, and detailing the different modes of communication at their disposal
  • Include a statement for drugs on the list referred to in Article 23 of Regulation (EC) No 726/2004 of European Parliament and of the Council of 31 March 2004, the notice must, in addition to the information mentioned above, include the statement that,
    • "This medicinal product is subject to additional monitoring"
    • This statement is to preceded by a black symbol referred to. Article 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 and followed by an explanatory sentence determined by the European Commission.

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LEEM HCP Code Updated in Jan 2014

The LEEM Healthcare Professional (HCP) Code has been updated.  The new code is effective from 1 January 2014.

 

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UK: MHRA Guidance on Medical Device Stand-Alone Software - Including Apps


Many manufacturers, software developer, academics, clinicians and organisations are using software for both healthcare and social care needs. 

 

This guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this seen to be part of the device, eg software that controls a CT scanner.

 

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EU: EMA Launches Pilot Early Access Program

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The European Medicines Agency (EMA) is inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases.

 

A framework to guide discussions of individual pilot studies has been published.

 

The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is part of the Agency's efforts to improve timely access for patients to new medicines. It is a prospectively planned process, starting with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.


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EU: European Medicines Agency Publishes First Summary of a Risk-Management Plan for a Medicine

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The European Medicines Agency has published the first summary for the public of the risk-management plan (RMP) of a newly authorised medicine. This RMP summary, which concerns the medicine Neuraceq, describes what is known and not known about the medicine's safety and states what measures will be taken to prevent or minimise its risks.  

 

The Agency will pilot the publishing of RMP summaries for all newly centrally authorised medicines during 2014 and at a later stage will start producing RMP summaries for previously authorised medicines.

 

This new type of publication is a further step towards increased transparency and public access to relevant information on medicines and is one of the requirements of the new European pharmacovigilance legislation. The RMP summaries complement the public-friendly information already available in the Agency's summaries of the European public assessment report (also known as EPAR summaries).

 

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Russia: New Requirements for HCOs who Conduct Clinical Trials

On 14 February 2014, Rossiyskaya Gazeta, the official edition of the Russian Government, published Order No. 300n of the Russian Ministry of Healthcare dated 16 May 2013 "On approving the requirements for healthcare organisations which conduct clinical trials of medical products, and the procedure for establishing whether the healthcare organisations comply with these requirements" (the "Order"). This order entered into effect on the 25th of February. 

 

Summary of the main changes

The Order sets out several requirements for healthcare organisations which conduct clinical trials of medical products and clinical trials for in vitro diagnostics. In addition, the instrument also determines the procedure for establishing whether a healthcare organisation complies with these requirements for the purposes of being officially declared competent and authorised to conduct clinical trials of medical products within the class of medical aid offered.

 

The Order actually introduces an additional licensing procedure, along with the existing procedures for licensing healthcare activities. Now, a healthcare organisation which conducts clinical trials of medical products must possess, in addition to a licence, a permit for clinical trials...

 

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