EMA Management Board: Highlights of December 2019 Meeting

The European Medicines Agency (EMA) released a summary of the December Management Board meeting on 20th December 2019. Some meeting highlights are as follows:

The Board adopted EMA’s budget for 2020 and a preliminary draft programme and budget for 2021. The 2020 budget is set at EUR 358 million, a 3.3% increase on 2019.

The Agency will need to prioritise the implementation of the new legislation for veterinary medicines and medical devices.

An update was provided on the outcome of the first phase of a pilot (run from April to August 2019) on the EU SPOC (single point of contact) network for cooperation on availability of human and veterinary medicines. The SPOC system was set up as a deliverable of the joint Heads of Medicines Agencies (HMA)-EMA taskforce on the availability of authorised medicines, to improve information-sharing on important shortages of medicines between Member States, EMA and the European Commission. It also allows Member States to share information on medicines that could be used as an alternative and are available in other Member States. During the first phase, 52 notifications of shortages were circulated within the SPOC network and 24 Member States made use of the SPOC system for sharing information on shortages during phase one of the pilot. A second phase is foreseen for 2020 during which additional responsibilities of the SPOCs will be tested which are expected to improve the handling of shortages.

Update on the EU IT systems required by the Clinical Trial Regulation: The Board endorsed the outcome of the ‘audit readiness assessment’ and endorsed the proposal to commence the audit in December 2020. The assessment was carried out on the Clinical Trial Information System (CTIS) to identify critical items that still need to be fixed/developed for audit. The outcome includes an updated plan that outlines the items needed for audit to commence by end of December 2020.

Handling new information on nitrosamine presence in medicines: As part of the EMA’s ongoing review into nitrosamine presence in medicines, in September 2019, EU regulatory authorities requested companies to assess the risk that their manufactured products contain nitrosamines and test products identified. The European medicines regulatory network has agreed to reinforce the use of interim limits for the evaluation of cases where nitrosamines are identified, in line with the report issued by the Agency on the sartan review. The Board welcomes the cooperation on the issue that is already ongoing at European level and encourages continued discussion with regulators from outside the EU.

The Board agreed to the mandatory use of the ISO ICSR format based on the ICH E2B(R3) modalities for the reporting of suspected side effects of medicines in individual case safety reports (ICSRs). The use of the new international standard will become mandatory as of 30th June 2022 for all reporting to EudraVigilance, the European database of suspected side effects reported with medicines authorised in the European Economic Area (EEA).

The Board endorsed the EMA–HMA–EC key principles for electronic product information (ePI) together with the roadmap. More information and relevant documents planned to be published in quarter one of 2020.

The EMA now has an available workforce of 775 which is significantly less compared to end 2017 when EMA’s relocation plans took shape.

https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2019-meeting

https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-december-2019-meeting_en-0.pdf

New Publications by the MHRA Inspectorate Blog

On 23rd December 2019, Jennifer Martin published a summary of the annual GCP Symposium which was held by the Medicines and Healthcare products Regulatory Agency (MHRA) on 11th September 2019 in Manchester, and was focused on non-commercial organisations. The publication provides an overview of the following discussed topics1:

  • Electronic Health Records (EHRs)
  • Oversight of Investigational Medicinal Product (IMP) Management
  • Investigator Oversight
  • Source Data Collection Systems
  • Safety Reporting for Non-Commercials
  • GCP Labs

1https://mhrainspectorate.blog.gov.uk/2019/12/23/mhra-gcp-non-commercial-symposium-2019/

The MHRA will be hosting a series of events as part of the Good Practice Symposia Week between 11th to 14th February 2020 which will include events from pharmacovigilance GPvP, GCP and GLP Inspectorates2.

The GPvP event will be held on 11th February. The MHRA informs that the event will include talks highlighting current challenges in pharmacovigilance faced by industry, latest MHRA GPvP inspection metrics and an update on the GPvP inspection strategy. There also will be the chance to hear about post-marketing safety compliance metrics from the US Food Drug Administration (FDA) and the cross-agency working initiatives between the two agencies. The event will provide the opportunity to join the afternoon technical sessions in the form of smaller seminars with inspectors.

Laboratories Symposium will be held on 12th February and will provide breakdowns of current laboratory regulatory requirements and expectations from monitoring authorities, as well as give attendees an insight into hot topics and areas of focus during regulatory inspections. Presentations will cover a range of topics including equipment qualification, analytical methods, training, quality management, computerized systems, reporting etc.

GCP Symposium (Commercial) is planned for 13th and 14th February and is in partnership with the US-FDA. The full event will be two days, with interactive presentations on day one followed on day two with interactive workshops. This event will provide regulatory perspectives from both the MHRA and FDA on the importance of sponsor oversight of clinical sites and laboratories, eSource including electronic health records, protocol deviations featuring the impact on data reliability as well as subject safety and the challenges in ensuring data quality in novel clinical trial designs.

2https://mhrainspectorate.blog.gov.uk/2020/01/14/mhra-good-practice-symposia-week-11-to-14-february-2020/

Medical devices — Application of Risk Management to Medical Devices: ISO 14971:2007 replaced by the version from 2019

The requirements of the ISO 14971:2019 which replaces version the version from 2007 are applicable to all phases of the life cycle of a medical device. The process described in the document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

https://www.therqa.com/news/

https://www.iso.org/standard/72704.html

https://www.iso.org/obp/ui/#iso:std:iso:14971:ed-3:v1:en

Veeva SiteVault Free, a Free eRegulatory Application, is Available Now to Simplify Study Execution at Clinical Research Sites

It was announced on 8th January 2020 that Veeva SiteVault Free, a free eRegulatory application, is available. This application is meant to be a solution for clinical research sites and it replaces manual and paper-based regulatory processes by providing a modern cloud application to manage investigator site files in compliance with 21 CFR Part 11 and HIPAA requirements.

Veeva SiteVault Free supports an unlimited number of studies, documents, and users and comes with customer support.

The publication provides a link to the web page where clinical research sites can sign up for Veeva SiteVault Free and also where to watch an on-demand webinar about the application.

https://www.businesswire.com/news/home/20200108005197/en

EMA: Human Medicines Highlights of 2019

The EMA released their overview of main recommendations of 2019 on the authorization of new human medicines and important safety advice issued last year on 09th January 2020. Sixty-six medicines received a positive opinion, 30 of which were new active substances. Four medicines received a negative opinion in 2019. Important new safety advice issued to several medications in 2019. For example, recommendation to revoke the marketing authorisations for fenspiride medicines following a review that confirmed that these cough medicines could cause heart rhythm problems; recommendation to restrict the use of the multiple sclerosis medicine Lemtrada (alemtuzumab) due to reports of rare but serious side effects, including deaths; recommendation to restrict the use of the multiple sclerosis medicine Gilenya (fingolimod) in pregnant women and in women able to have children who are not using effective contraception (the review confirmed that the medicine can harm the unborn child) and other examples of safety advices. Full overview is available at EMA’s web page below.

https://www.ema.europa.eu/en/news/human-medicines-highlights-2019

https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2019_en.pdf

MHRA phase I Accreditation Scheme: New List of Accredited Units added

On 8th January 2020, MHRA added a new list of accredited phase I units. The list, as well as phase I accreditation scheme requirements, guidance and links to other useful information on the topic can be found following the GOV.UK web site using the link below.

https://www.gov.uk/guidance/mhra-phase-i-accreditation-scheme#history

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