Regulatory Round-up - August 2023

UNITED KINGDOM

Medicines and Healthcare products Regulatory Agency (MHRA)

Use of UK plasma for the manufacture of albumins and vCJD risk

The MHRA has undertaken a further review of the safety of albumins manufactured from UK plasma with respect to vCJD. Based on current epidemiology, manufacturing process capability, expert advice and information collected for previous reviews, it was concluded that UK-sourced plasma can be used for the manufacture of albumin medicinal products, in addition to the already approved use for the manufacture of immunoglobulins.

The full report can be found here.

EUROPE

European Directorate for the Quality of Medicines (EDQM)

Elemental impurity chemical reference standards (CRS) available in the EDQM reference standards catalogue

Elemental impurity chemical reference standards (CRS) of Lead solution Cadmium solution , Mercury solution, Arsenic solution, Nickel solution, Palladium solution and, most recently, Platinum solution are now available in the EDQM RS portfolio.

The EDQM provides SI-traceable primary reference materials that support pharmaceutical manufacturers in implementing relevant public health standards, such as the ICH Q3D Guideline for Elemental Impurities. Please find further information here.

European Medicines Agency (EMA)

Strengthening life-sciences innovation across Europe: EU-Innovation Network conference

Taking place on the 21^st of November 2023, the European Innovation Network (EU-IN) is organising a conference hosted by the Health Products Regulatory Authority (HPRA) in conjunction with European incubators and technology transfer offices (TTOs) to support the translation of innovative biopharmaceutical and medical technology developments.

The objectives of the conference are to enable and support early translation of innovation by:

• Increasing awareness on EU’s scientific and regulatory advice toolbox and EU funding opportunities available to innovative developers
• Promoting the support by incubators and TTOs to innovative developers
• Identifying innovative developments in priority areas to contribute to the EU, European Medicines Agency and EU regulatory network readiness
• Facilitating dialogue and promoting collaborations between innovative developers, incubators, TTOs, funders and regulators
• Accelerating and strengthening European innovation ecosystems across the EU.

Please find further information on this event here.

CTIS newsflash – 18 August 2023

Please find key updates on CTIS and links to useful reference materials here.

Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop – Smart regulation on a rapidly evolving world

The joint HMA/EMA workshop on Artificial Intelligence (AI), which will take place on 20^th – 21^st November 2023 follows on from the 2021 workshop where stakeholders provided their views on priority AI-related topics. The Medicines Regulatory Network (EMRN) has worked on delivering on these priorities and monitoring the rapid evolution of AI tools and techniques and the developing legislative environment.

The aim of the workshop is to:

• Engage stakeholders with speakers on AI developments in technology, policy and potential applications in medicines regulation
• Provide information on the HMA/EMA activities to deliver the stakeholder’s priorities on AI
• Discuss the draft AI reflection paper with stakeholders and experts.

Please find further information on this event and how to register here.

Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS

The EMA has announced a public webinar taking place on 15^th September 2023 for pharmaceutical industry companies interested in learning more about the Regulatory Procedures for medicinal products onboarding on IRIS.

The onboarding of regulatory procedures on IRIS will lead to process simplification and standardisation for marketing authorization holders (MAHs), allowing the decommissioning of SIAMED.

Please find further information including how to register here.

European Compliance Academy (ECA)

Good Distribution Practice (GDP) Audit Check List for Road Transport Operations

The ECA Academy has compiled a question list for Road Transport Operations and Air, Road and Ocean logistics to support GDP Audit purposes. These are suggestions that organisations might find useful.

USA

Food and Drug Administration (FDA)

Clinical Trials: The Patient Experience- Workshop 13 April 2023

Slides, transcript and recording of the 13 April 2023 of the Clinical Trials: The Patient Experience workshop event are now available here.

FDA issues Draft Guidance on Post-marketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

Clinical trials should include patient populations that are historically underrepresented in clinical research and it is required by FDA regulations that sponsors present information from premarket clinical trials on the safety and effectiveness of drugs in terms of gender, age, and racial subgroups. However, if these populations are not adequately represented in the premarket clinical trials despite of the sponsors’ best effort, it may be appropriate to collect such data in the post-marketing setting. The aim of this guidance is to outline the FDA requirements and provide recommendations for obtaining safety and effectiveness information on drugs, when appropriate, in the post-marketing setting in historically underrepresented patient populations in clinical trials.

Public consultations

Medicines and Healthcare products Regulatory Agency (MHRA)

EUROPEAN MEDICINES AGENCY (EMA)

Food and Drug Administration (FDA)

International Conference on Harmonisation (ICH)

Click here to download the PDF