Last week’s round-up;
12 – 16 October 2020

published 19 Oct 2020

EU COVID-19 Vaccine Strategy – Labelling and packaging flexibilities

The European Commission (EC) has released a Memorandum of Understanding (MoU) with Member States on regulatory flexibility for labelling and packaging of centrally authorised COVID-19 vaccines during the pandemic.

The regulatory flexibilities described in the MoU are an essential tool to help accelerate the development, authorisation and availability of COVID-19 vaccines while still maintaining the standards for vaccine quality, safety and efficacy.

Some of the regulatory flexibilities covered in the MoU include:

• To limit the information on the immediate and outer packaging to one EU official language, preferably English.

• The acceptability of multi-dose presentations.

• The possibility of separate distribution of a print out of the package leaflets to accommodate for one patient leaflet per dose and for the accelerated availability of the vaccine.

• The omission of country specific blue box requirements and use of one Global Trade Identification Number (GTIN) for serialisation, where possible.

IGBA new policy paper on clinical biosimilar development

The International Generic and Biosimilar medicines Association (IGBA) has released a new policy paper: “Developing a Regulatory Framework Supporting Biosimilar Competition: The Opportunity for Tailored Clinical Biosimilar Development”.

Through the policy paper, the IGBA provides a guide to regulatory authorities on how they may contribute to building a conducive environment for sustained biosimilar competition, which is a critical component of more equitable access to biological medicines, especially in view of the challenges that the COVID-19 pandemic has imposed on patient access to medicines.

The paper focuses on two main areas including the streamlining of biosimilar regulatory requirements, particularly concerning clinical biosimilar development, and the pivotal role of regulators in informing and educating healthcare community stakeholders about the greater reliance on analytical data over clinical studies in biosimilar development.

Biosimilars – MHRA Draft Guidance

The MHRA has released a new draft guidance on the requirements for licensing biosimilars in the UK.

The document is based on the EMA’s biosimilar guidance, however, it also includes information on UK reference products, the lack of requirement for in vivo studies in animals, and the changes in the requirement for a comparative efficacy trial in most cases.

The draft guidance is open for public consultation until the 15th November 2020. Stakeholders may submit their comments through the response form available on the MHRA website:

Data Monitoring Committee issues Q&A Adopted

A new Q&A on Data Monitoring Committee (DMC) issues has now been adopted and published by EMA. The purpose of this document is to supplement the CHMP Data Monitoring Committee guideline (EMEA/CHMP/EWP/5872/03) by providing clarification on

1. the role and necessity for a DMC in different phases of drug development and throughout the product lifecycle and

2. The responsibilities for implementing DMC decisions.

Further details and the Q&A document can be found here: 

Pharmeuropa PaedForm Issue 2 – Furosemide 2 mg/mL Oral Solution

The EDQM has just released issue 2 of Pharmeuropa PaedForm, which includes the draft text for an ethanol-free formulation for Furosemide 2 mg/mL Oral Solution. Following public consultation the monograph will be included in the European Paediatric Formulary.

Currently authorised furosemide oral solutions contain a significant amount of ethanol, which is of concern for specific age groups. However, Furosemide 2 mg/mL Oral Solution is ethanol-free and contains other excipients and preservatives to ensure the stability of the solution throughout its shelf-life.

Pharmeuropa PaedForm Issue 2 is available for comment until the 31st December 2020.

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