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Nov 18, 2019

Status of ICH Guidelines implementation by ICH Regulatory Members
On 1 November 2019 a report of monitoring the adequacy of implementation and adherence to ICH guidelines available on the ICH website

ICH Guidelines are implemented in accordance with the applicable national/local/regional rules, with the stage of implementation of all ICH Guidelines also being dependent on when a Member or Observer has joined ICH.

Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus. ICH is working to understand the level of implementation and adherence to ICH Guidelines within Regulatory Member and Observer countries/regions and in 2019 conducted an ICH-driven independent third-party survey in support of this effort. Furthermore, recognising the need to have a common view on different degrees of implementation, ICH has also developed Definitions of terms in the context of the implementation of ICH Guidelines.

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EudraVigilance Release Notes v.1.22
On 4 November 2019 the EMA updated the EudraVigilance Release Notes v1.22

This document lists and briefly describes the following areas for the releases of the EudraVigilance system. This includes the EudraVigilance messaging system, the EVWEB interface and the EV post function, and the EduraVigilance registration system:

  • What's New: The enhancements and other changes released (new feature).
  • Known Issues: The issues that exist (open issue).
  • Fixed Issues: The issues that are fixed (fixed issue).
  • Points to Note: The important aspects to keep in mind (point to note).

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Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
On 7 November 2019 the FDA is establishing a public docket to collect comments on the draft document. Comments may be submitted by 6 January 2010

This document sets forth risk-based principles by which the FDA conducts ongoing postmarketing safety surveillance for human drug and biological products (biologics). The main topics this document addresses include:

  • A multidisciplinary, life-cycle approach to the management of drug and biologic safety.
  • General considerations that inform the frequency and extent of systematic drug and biologic safety monitoring.
  • Additional considerations based on specific product types and patient populations.
  • Safety signal identification based on screening and data mining of the adverse event (AE) reporting system and other data sources, including general practices for the frequency and extent of screening these data sources, as well as prioritizing identified signals.
  • A multidisciplinary, comprehensive evaluation of the identified safety signal that integrates the cumulative data gathered from all available sources.
  • An assessment of the causal association between the identified AE and the product.
  • An overview of regulatory and other actions that can be taken in response to identified safety signals.

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EMA EudraVigilance Registration Manual
On 13 November 2019 the EMA published the updated EudraVigilance registration manual

To set-up a new organisation in EudraVigilance, a series of steps need to be followed:

1. A person within the organisation needs to be chosen as being responsible for managing the organisation and its users in the EudraVigilance system. If the organisation is a marketing authorisation holder the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV).

2. Register for an EMA user account in the EMA Account Management portal if you do not already have one (see 2. User registration with EMA Account Management portal (IAM)

3. Check Organisation Management System (OMS): if your organisation is not present in OMS it will need to be registered (see 4. Create a new Organisation

4. Submit request to be registered as the responsible person for the organisation (see 3.2. EU QPPV or Responsible Person access request

5. Complete organisation registration details in the EudraVigilance restricted area (see 4.1. Finalise organisation information in EVHuman Production

6. Set up the transmission mode (see 5.1. Annex EV restricted area and transmission mode for new organisation

7. Raise Service desk ticket to set up gateway connection or a webtrader connection if you need to send XEVMPD messages

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New Organization First User QPPV/RP or Change of EU QPPV/RP
On 13 November 2019 the EMA published the updated First User or Change of EU QPPV/RP for new organization

If a change of qualified person for pharmacovigilance/responsible person for EudraVigilance (QPPV/RP), named person or legal representative within the organisation occurs, you need to notify EMA.

There are 2 possible scenarios, please choose the one relevant to your case.

A) There is still a QPPV/RP in your organisation – change of QPPV/RP

B) There is no QPPV/RP in your organisation – first user QPPV/RP of a new organisation

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EMA Regulatory Science to 2025 - Five goals
On 14 November 2019 the EMA updated its five goals for human medicine regulation

The European Medicines Agency updated the below five goals through to 2025:

  • Catalysing the integration of science and technology in medicines development
  • Driving collaborative evidence generation and improving the scientific quality of evaluations
  • Advancing patient-centred access to medicines in partnership with healthcare systems
  • Addressing emerging health threats and availability/ therapeutic challenges
  • Enabling and leveraging research and innovation in regulatory science

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Guideline on clinical investigation of medicinal products for the treatment of gout
On 14 November 2019 EMA updated the guidance to provide the evaluation of drugs for the treatment of gout. This guide will come into effect on 1 June 2020.

The main aim of the guideline is to address general guidance on the development of medicinal products for the treatment of gout. This guideline should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations.

In this document, guidance is provided on the clinical development of new urate lowering therapy and anti-inflammatory treatment options. The study design, inclusion criteria, primary endpoints and trial duration largely depend on the treatment goal and mode of action of the new drug.

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Smallpox (Variola Virus) Infection: Developing
Drugs for Treatment or Prevention Guidance for Industry

On 15 November 2019 the FDA announced the availability of the final guidance for industry to assist sponsors in the clinical development of drugs for treating or preventing smallpox (variola virus) infection.

The purpose of this guidance is to assist sponsors in the clinical development of drugs for treatment or prevention of smallpox (variola virus) infection. Clinical efficacy trials of drugs for treating or preventing smallpox are not feasible and challenge studies in healthy subjects are unethical; therefore, drugs for these indications should be developed and approved under the regulations commonly referred to as the Animal Rule (21 CFR part 314, subpart I, for drugs and 21 CFR part 601, subpart H, for biologics). This guidance serves as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public.

This guidance focuses on drugs that are expected to inhibit variola virus replication. Although antiviral drugs are the primary focus of this guidance, therapeutic proteins or monoclonal antibodies also may be eligible for evaluation under the Animal Rule. Sponsors interested in developing small molecules, therapeutic proteins, or monoclonal antibodies for use against smallpox are encouraged to discuss their approach with the FDA as early as possible in development and to communicate with the FDA through the Pre-IND Consultation Program.

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