Posted on 07 Sep 2021

Regulatory News September

Awarded Paper: Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities. 

At the recently concluded DIA2021 Global, Novartis' David Lewis and Roche’s Fraser McCallum received the 2021 DIA Global Inspire Award for Author of the Year for their IAO Foundation Paper in DIA’s Therapeutic Innovation & Regulatory Science journal. Their paper entitled “Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities” is available here.

EMA’s consideration on core requirements for PSURs of COVID-19 vaccines - corePSUR19 guidance.

Introduction / Background
This guidance reflects the EMA recommendations on PSURs for COVID-19 vaccines based on current knowledge and experience. As the pandemic situation evolves and further evidence on the benefits and risks becomes available for the vaccines, the Marketing authorisation holders (MAHs) should take into account current guidance and experience communicated by EMA , in the form of updated guidelines or through the scientific assessments already completed (e.g. PSUR assessment reports, monthly summary safety reports assessment reports). MAHs are reminded that the Monthly Summary Safety Reports (MSSRs) are not meant to replace the PSURs. Therefore, all relevant information (safety signals evaluations, regulatory requests…) in scope of the reporting period should be provided in the PSURs. However, all those safety evaluations or regulatory requests that have been closed during the reporting period in the context of another regulatory procedure should provide a cross reference to the corresponding procedure.

This corePSUR19 document addresses the planning for post-marketing safety surveillance for COVID[1]19 vaccines in the context of periodic safety update reports.

To provide guidance and highlight requirements when drafting the PSURs of COVID-19 vaccines.

CorePSUR19 requirements and guidance
This guidance should be read in conjunction with existing relevant EMA guidance (including Good Pharmacovigilance practices (GVP)- Module VII- Periodic Safety update Reports, Explanatory Note to GVP Module VII , Guideline on good pharmacovigilance practices (GVP) Module IX – Signal management (Rev 1) Product-or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases, Product- or Population-Specific Considerations III: Pregnant and breastfeeding women, Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data. coreRMP19 guidance Good practice guide on recording, coding, reporting and assessment of medication errors, Detailed guidance on ICSRs in the context of COVID-19 Validity and coding of ICSRs) published on the EMA website; the requirements and guidance provided should be read and applied in the context of pandemic use of COVID-19 vaccines. This guidance will be updated once vaccines with multiple or different strains are authorized to provide guidance on how to best present the data, if considered necessary.

Explanatory Note to GVP Module VII Rev. 3 dated 19 April 2021 (EMA/670256/2017 ).

Rev. 3 of the Explanatory Note to GVP Module VII is available at this link: Explanatory Note to GVP - update Feb 2021 .(

EMA’s post-authorisation procedural advice for users of the centralised procedure - 23 Jul 2021

EMA's post-authorisation procedural advice document provides a printable overview in Q&A format of EMA's position on issues typically addressed with marketing authorisation holders. EMA regularly updates the Q&A to reflect new developments, additional guidance and the implementation of new European legislation. A track-changes version shows the latest updates. New or revised Q&As are labelled 'New' or 'Rev' respectively together with the relevant date.

EMA consultation: Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells. 

The European Medicines Agency has published for public consultation a “Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells”. This guideline describes the information to be included in the Summary of Products Characteristics (SmPC), Labelling and Package Leaflet for Advanced Therapy Medicinal Products (ATMPs) containing genetically modified cells. The purpose of this core SmPC, Labelling and Package Leaflet (hereby referred to as core SmPC) is to provide applicants and regulators with harmonised guidance on the information to be included in the Product Information (PI) of ATMPs containing genetically modified cells.
This core SmPC only covers medicinal products containing genetically modified cells, allogeneic or autologous, including viral vector modified and genome edited cells.
Comments should be provided using this template and sent to by 31 October 2021.

EMA’s public consultation on draft EU Common Standard for electronic product information (ePI)

EMA, national competent authorities and the European Commission are conducting an electronic product information (ePI) set-up project throughout 2021. ePI is authorised, statutory product information for medicines (the summary of product  characteristics [SmPC, intended for healthcare professionals], labelling [outer and inner packaging information] and package leaflet [PL, for patients / consumers]) in a semi-structured format created using the EU Common Standard. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print. An EU Common Standard for ePI refers to the technical features of ePI to be agreed by regulators and stakeholders. The documentation for the draft EU Common Standard is the subject of this consultation. It consists of 1. A FHIR xml template based on the Quality Review of Documents (QRD) template for human medicines. 2. ePI API Specification (PDF) and the associated ePI API service list (Excel) 3. An instance of an ePI sample message is provided in XML and HTML, along with a sample XSL transformation. Consultation feedback is collected via this survey (open in Chrome) and deadline for submission is 31 July 2021. The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.

EMA’s annual report 2020

The European Medicines Agency’s annual report 2020 is now available on the Agency’s website. The digital report outlines the most important highlights of the evaluation and monitoring of human and veterinary medicines, the European medicines regulatory network’s rapid response to COVID-19, and a high-level overview of key figures. The narrative is complemented by an interactive timeline of EMA’s main activities in 2020 that allows you to explore each topic in more depth, for example through additional audio-visual materials, infographics, videos and documents.

In 2020, EMA and its partners within the European medicines regulatory network had to adapt processes to ensure a rapid response to the COVID-19 pandemic whilst maintaining core regulatory activities to protect public and animal health in the European Union (EU). The report details EMA’s work during the pandemic and highlights key lessons learnt in 2020.

Additional topics covered by the report include the Agency’s response to other public health challenges, such as antimicrobial resistance, and also EMA’s relocation to a new permanent headquarters in Amsterdam, and the preparations for Brexit. The report also describes how the Agency marked its 25th anniversary and explains the steps EMA took to ensure that it is fit to tackle future scientific and technological challenges and take on new responsibilities.

As usual, the second chapter of the report contains core statistics that illustrate the main outcomes of the Agency's regulatory activities, as well as interesting trends and changes observed in recent years. More detailed statistical information about EMA can be found in a traditional print-ready PDF version that is published alongside the digital annual report.

EMA’s monthly Newsletter 

(which includes decisions by Scientific Committees and updates on medicines safety): you can access the Newsletter by clicking here. Previous editions can also be found on this page. It includes topics related to the COVID-19 vaccines.

EMA’s updates on COVID-19 vaccines:

  • COVID-19: latest updates
  • Treatments and vaccines for COVID-19
  • Guidance for medicine developers and other stakeholders on COVID-19
  • Availability of medicines during COVID-19 pandemic
  • Public-health advice during COVID-19 pandemic
  • EMA’s governance during COVID-19 pandemic

All the latest updates on COVID-19 vaccines and treatments are available by clicking here.

MHRA-Canada guidance on DSURs. 

The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have jointly published new guidance to improve the safety of patients in clinical trials through improved quality of the periodic safety reports known as Development Safety Update Reports (DSURs). The guidance applies to both marketed and non-marketed medicines that are undergoing clinical trials. DSURs review the safety of medicinal products used in clinical trials and are produced every year. At present, even though trial sponsors will have conducted assessments regarding safety concerns, these detailed safety assessments are not always included in the DSUR. This makes it difficult for some regulators to find out if all safety concerns have been thoroughly investigated and whether appropriate measures have been taken to mitigate the risks associated with the use of the investigational medicinal products during a trial. This guidance will improve transparency and ask sponsors to explain in the region-specific information section how they assessed the data included in the DSUR. The guidance builds on relevant existing international standards, including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance E2F, the Council for International Organizations of Medical Sciences (CIOMS) Working Group VII as well as each country’s relevant clinical trial legislation.

FDA - Global Regulations Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines. 

Concerned about the dearth of information available on the safety and effectiveness of medical products for pregnant and breastfeeding women, the U.S. Food and Drug Administration and many of its regulatory counterparts around the world say it is time to address inadequacies in research through a paradigm shift in the approach to studying medical products in these populations. The FDA kicked off efforts to improve information on the safe use of medicines in pregnancy and during breastfeeding with the Pregnancy and Lactation Labeling Rule (/drugs/labelinginformation-drug-products/pregnancy-and-lactation-labeling-drugs-final-rule), finalized in2014, requiring companies to keep product labeling up to date with any data relevant to these populations. The rule stops short, though, of requiring collection of such data through clinical trials or studies. In response, the FDA has been involved in many activities to address this, too numerous to list here, but highlights include issuance of three draft guidance documents and one final guidance document to help encourage the inclusion of pregnant and breastfeeding women in clinical trials.

A major paradigm shift is necessary from the systemic exclusion to the inclusion of pregnant and breastfeeding women in clinical studies. This is essential to ensure the availability of information that is critical for informed decision-making when patients who are pregnant or breastfeeding an infant need medicines. Developing a roadmap for change, through international cooperation and harmonization, will take much care, consideration, and communication between all stakeholders. Despite persistent challenges, there is strong interest from the international regulatory community to continue the momentum in this important area of women’s health. The FDA intends to display leadership in such efforts with women, healthcare professionals, industry, and public health experts.

Good Pharmacovigilance Practice in China. 

On 13 May 2021, the National Medical Products Administration (NMPA) issued the Good Pharmacovigilance Practice (GVP) (Chinese language), effective from 1 December 2021. According to the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, NMPA has organized to formulate the Good Pharmacovigilance Practice to standardize and guide drug marketing authorization holders and drug registration applicants to conduct pharmacovigilance activities, which has issued on May 7. The issues related to the implementation of the Good Pharmacovigilance Practice are hereby announced as follows:
I. The Good Pharmacovigilance Practice will come into force as of 01 Dec 2021.
II. Drug marketing authorization holders and drug registration applicants shall actively prepare for the implementation of the Good Pharmacovigilance Practice, establish and continuously improve the pharmacovigilance system and conduct pharmacovigilance activities in a standardized manner.
III. Drug marketing authorization holders shall complete information registration at the National ADR Monitoring System within 60 days upon issuance of this Announcement.
IV. All the provincial medical products administration shall supervise and urge the drug marketing authorization holders within their respective administrative areas to actively make preparations, cooperate with relevant publicity and interpretation, supervise and guide drug marketing authorization holders to implement the Good Pharmacovigilance Practice as required by strengthening routine inspection and other activities, and in a timely manner collect and feedback relevant questions and comments.
V. The National Center for ADR Monitoring shall organize and coordinate the publicity, training and technical guidance for the Good Pharmacovigilance Practice in a unified manner and set a special column of the Good Pharmacovigilance Practice on its official website to reply to questions and comments in a timely manner.