EMA and Brexit Yet Again: Part 2

Sep 05, 2018

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

EMA and Brexit Yet Again: Part 2

As I noted in my last post, the Brexit and EMA saga continues.


From the EMA  Perspective

There are two important documents to briefly look at to get an idea of where the EMA is going.


EMA Final Programming Document

The first is the “Final Programming Document 2018-2020 issued by the EMA in December 2017. It is 153 pages long. We will do a brief review of the information relevant to PV and Drug Safety.

First there is a review of the mission and goals. Next a discussion of challenges and risks which runs a dozen pages. The key challenges are:

  • Making sure the new premises are available on time and fit-for-purpose
  • Transferring and maintaining operational IT systems
  • Ensuring the necessary procurements are run and services are provided
  • The logistics of the actual move of the organisation and staff, with minimum disruption to its day-to-day activities

There are several work flows and they may be examined in the document. In each flow there are three sets of priorities: 1) highest priority-covering core scientific activities including protection of the safety of patients, inspections and IT 2) medium priority and 3) lowest.

The choices for each activity are 1) continue business as usual 2) temporary reduction either of volume or time but maintain high standards and 3) suspension of activities.


The following cutbacks may touch DS and PV:

  • Category 3: Some conferences meetings (unspecified) at EMA or elsewhere, some training, some requests for information
  • Category 2: Some PV and quality training as well as some interactions with industry will be suspended, certain interactions with industry; decrease in translations; training on certain newly rolled out system of which they site as an example “ADRs”.
  • Category 1: None


Next the ongoing projects covering the EMA are listed, along with the performance indicators and the start stop dates for projects due to end in 2019 or 2020.  Some projects will be affected, including:

  • Planned access of real world data and patient registries for novel medicines will have reduced activity in 2018 and 2019.
  • PV fees are expected to increase by about 3% through 2020.
  • Referrals for possible benefit-risk reevaluation to obtain a consensus will continue as planned for PV with 8 expected in 2018.
  • PV activities including PSUR assessment within the legal time frames, protocols and reports for non-interventional safety studies, reaction-monitoring reports and PRAC recommendations are all expected to continue at 100%
  • There will be reduced activity in in 2018 and 2019 on the development of the vaccine risk-benefit blueprint, public consultations and reports regarding safety and pregnancy/breastfeeding, pediatric population safety, geriatric safety, review of GVP Mod VII (PSURs) and XVI (Risk minimization tools and effectiveness indicators, EU network ability to do analysis of epidemiologic data, review of the scientific advice process for PASS studies.
  • There will likely be an increased amount of activity regarding PV responsibilities and MAs now held by UK based companies which must transfer to another EU member state after Brexit.
  • The number of EU PV inspections is expected to remain steady at about 14 in 2018 though due to a recent agreement with FDA there may be more inspections done by FDA and possibly other non-EU countries’ health agencies. However the plan to set up a pilot phase program with the FDA on sharing information on PV inspections which was due to end in 2018 will now not end till 2020 with reduced activity in 2018 and 2019.


In early August the EMA issued an update indicating that phase 3 will be put in place no later than October 1, 2018 and that the peak relocation activities will start in early 2019 (giving them under 3 months to relocate).  Further details on these activities will be released shortly.


Other EMA News


From the UK MHRA Perspective

Now through March 31, 2019

  • The UK remains a full member of the EU and EMA.
  • The UK Parliament voted 305-301 for the MHRA to remain a part of the EMA after Brexit. In a joint statement, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said, “Today, Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the [United Kingdom] from the [European Union] and 45 million move the other way. Therefore, it is essential that the [United Kingdom] continues to participate in the EMA after Brexit.”  
  • The MHRA explained that there will be an implementation period for the UK through December 2020 during which certain procedures and requirements in place will remain or be altered in a careful manner. This has been agreed upon in the European Council by the UK and EU. However, during this period the UK will not have any voting rights in the EMA.
  • The UK passed in 2018 the EU Withdrawal Act which, among other things, allows the transposition of already existing EU law into UK law to be called “retained EU law.”


During the Implementation Period (March 31, 2019 – December 2020)

  • The UK government has further commented on this in August 2018 in two documents:
    • 1) Implementation period: what it means for the life sciences sector
    • 2) Technical information on what the implementation period means for the life science sector

    • “Marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets.” There will still be mutual recognition of some inspections including GMP.
    • The EU is expected to implement a new clinical trials regulation (CTR) in 2020 and this will therefore apply to the UK at least through the end of 2020.
    • Article 123 of the draft Withdrawal Agreement states that “During the transition period, the United Kingdom shall not act as “leading authority” for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States… A “leading authority” conducts assessments on behalf of specific EU agencies. The UK and EU are still discussing the scope of activity that this article will cover with respect to medicines


  • PV & Regulatory Issues
    • To give businesses, organisations and citizens certainty, common rules will remain in place until the end of the implementation period. Therefore, a the qualified person for pharmacovigilance may continue to be located in the UK during the implementation period.
    • As access to one another’s markets will remain unchanged and on current terms, the pharmacovigilance master file will not need to be located in both the UK and EU during that time.
  • Other points (See the document for more detail):
    • During the implementation period, the MHRA may attend EMA and EU committees and any groups where there is a UK interest, or where relevant to the EU. The exact nature of this participation is a matter for further discussion.
    • During the implementation period, the UK will continue to respect the decisions reached by the various EU committees regarding the regulation of medicines and medical devices
    • During the implementation period industry would be able to continue to submit information to the MHRA using the existing submission routes. The UK will continue to access all EU databases and systems that we currently have today.
    • During the implementation period industry would be able to continue to submit information to the MHRA and using the existing submission routes. The UK will continue to access all EU databases and systems that we currently have today. However: The UK and EU are still discussing the scope of activity that this article will cover with respect to medicines.
    • The MHRA will also carry on discussing issues with EU counterparts and sharing information as now, including continued access to EMA and EC databases and sharing of vigilance data.
    • During the implementation period the UK will not diverge from current labeling requirements.

In my next post, I’ll go into more depth about the lack of a Brexit agreement between the UK and the EU.



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