BREXIT – No extension to the transition period

It seems that Brexit is on course for 1st January 2021….

The 30th June 2020 came and the legal deadline for agreeing to an extension of the transition period has passed with no request from the UK. Therefore the Brexit trade deal transition phase will come to an end on the 31st December 2020. At this stage there will be one of two possible outcomes:The next important dates are the 15-16th October (European Council Meeting) and 26th November (penultimate plenary session of 2020. European lawmakers have stated that a trade deal must be negotiated, checked, translated and presented to the European Parliament by this date if the transition period is to end by 31 December 2020). If the UK exits without a trade deal, trade between the UK and EU will change immediately on the 1st January 2021 (i.e. Hard Brexit).

The European Commission (EC), European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have recently reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/brexit_technicalnotice_ct_en.pdf

The UK Government launched a major new public information campaign to give everyone the facts that they will need to be ready for 1 January 2021. A straightforward checker tool at gov.uk/transition will help identify some of the specific steps any business or individual needs to take to be ready, and will allow companies to sign up for bespoke updates.

To keep up to date with all EMA advice on Brexit please refer to the following: https://www.ema.europa.eu/en/about-us/brexit-united-kingdoms-withdrawal-european-union

For more detailed information about how 2020 currently looks with regard to Brexit please see: https://ivowen.com/brexit-everything-stays-the-same-for-2020/

If you require any assistance for UK products please contact us: info@ivowen.com

Written by Emily Fletcher

Emily Flecther

 

Advanced Therapy Medicinal Product (ATMP) classification

Did you know, that pharmaceutical companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is considered an advanced therapy medicinal product (ATMP)?

In doing so, they are allowed to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP. The criteria for ATMPs are set out in Article 17 of Regulation (EC) No 1394/2007.

In order to submit an application for ATMP classification, applicants have to complete a:

  • pre-submission request form
  • ATMP-classification request form and briefing information

and return both forms to the EMA.

Applies to your company? Ivowen are here to assist you.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton

Clinical Trials Regulation EU No 536/2014 – What does this mean for you?

When the Clinical Trial Regulation (No. 536/2014) comes into effect in 2018, there will be a major change on how clinical trial applications are submitted and how clinical trials are conducted in the EU.

The goal of the new Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.

 

Below you will find a brief summary of the changes:

Directive 2001/20/EC (Current)

  • Multiple submission for one trial (1 submission per each MS)
  • Double submission with a MSC: to NCA and EC
  • Individual assessment by Each MSC with no IT collaboration tool available
  • No Single MSC decision (NCA and ECs)
  • Limited EudraCT data availability to the public

Regulation 536/2014 (New)

  • Single e-submission to all MSCs
  • Harmonised dossier for one trial and
  • e-submission of structured data and documents by MSCs
  • Specific timeline
  • Joint assessment for PART I  facilitated by collaboration tool
  • Single MSC decisions
  • Single web-based EU portal
  • Distribution of the burden among users
  • View all CT relation information

 

Transition period (3 years) Directive 2001/20/EC (current) to Regulation 573/2014

  • Starts when Regulation becomes applicable (~ Oct 2018)
  • 1st Year: Clinical Trials can be submitted under old/current (Directive) or new (Regulation) system
  • 2nd & 3rd Year: Trials authorised under old system can remain under that system, New/initial Clinical Trials should comply the Regulation System
  • All Clinical Trials to switch to the Regulation 3 years after implementation (~ Oct 2021)

 

Typical Documents to be submitted:

  • Part I: Cover letter (very important), EU AF, Protocol, IB, GMP compliance documents, IMPD, Auxiliary Medicinal Product Dossier, Scientific Advice, PIPs, and labelling, proof of payment, etc.
  • Part II: Recruitment arrangements, SI/ICF/ICF procedure, suitability of the investigator, suitability of the facilities, proof of insurance cover or indemnification, financial and other arrangement, proof of payment, etc.

 

Part I Timetable Coordinated assessment (also applies to Mono-national Clinical Trials)

  • Day 0: Validation
  • D26: Draft Part I Assessment Report made available by the RMS (reporting MS) to the CMS
  • D38: All CMS share considerations
  • D45: RMS finalises the Part Assessment Report
  • D57: Sponsor submits response (w/n 12days)
  • D69: Co-ordinated assessment between MSs (12 days)
  • D76: RMS files conclusion (7days)

 

Part II Timetable National evaluation

D0: Validation

D45: Final assessment report from each MSC submitted

D57: Sponsor submits response

D76: Final assessment by the MSC shall be performed (w/n 19 days)

Submission of Part I and II in parallel (recommended) or submission of Part I followed by Part II (not less than 2 years after Part I)


Important Notes:

  • New MSs can only be added after the notification date of the initial authorisation decision
  • Withdrawal of MS: the whole application has to be withdrawn and resubmitted

Transparency:

EU Database will be publically accessible by default, with exceptions justified on any of the following grounds

  • Protection of personal data
  • Protection of commercially confidential information in particular taking into account the MA status of the medicinal product, unless there is an overriding public interest in disclosure
  • Protecting confidential communication between Member State in relation to the preparation of the assessment report
  • Ensuing effective supervision of the conduct trial Member States

 

Where can I find more information?

Information on Clinical trials – Regulation EU No 536/2014, General information, Guideline EU

Clinical Trial Portal and Database, Transparency, Safety reporting, Clinical trials conducted outside the EU, Contact points can be found here: https://ec.europa.eu/health/human-use/clinical-trials/regulation_en

 

We can help…

Ivowen are fully equipped to submit for Clinical Trials Applications on your behalf. Please contact us for more information and for support of your dossier compilation or updates.

 

Written by: Fiona Downey