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Biopharma industry encouraged by EMA’s COVID-19 transparency measures

IFPMA and EFPIA welcome new transparency measures for potential treatments and vaccines

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have welcomed the European Medicines Agency’s (EMA) new COVID-19 initiative.

The initiative will be used to implement transparency measures that target regulatory activities for the review and approval of treatments and vaccines for COVID-19.

The EMA announced a number of exceptional transparency measures which are focused on expediting the publication of key documents relating to COVID-19 treatments and vaccines. This includes news announcements for rolling reviews and compassionate use options. The agency will also implement shorter timeframes for publishing public assessment reports.

Additional measures, following marketing authorisation, are set to include publication of the complete version of the risk management plan and clinical trial data used to support regulatory approval of all COVID-19 treatments and vaccines.

The biopharmaceutical industry, represented by the IFPMA and EFPIA, has called on other national regulatory authorities to follow in the steps of the EMA and implement similar measures.

“As an industry, we recognise that there are important public health benefits associated with making clinical trial results more widely available and hope that such measures will help to broaden confidence in the science and the decision-making that is guiding the development of medicines and vaccines for COVID-19,” said Thomas Cueni, director general of the IFPMA.

In September, the chief executive officers of a number of top companies working on COVID-19 vaccines issued a joint pledge promising to uphold rigorous safety and efficacy protocols during and after the clinical development of their respective candidates.

The pledge was co-signed by the CEOs of nine pharma and biotech companies, including the leaders of AstraZeneca, Johnson & Johnson, Merck, Moderna and Novavax as well as Pfizer and BioNTech, and Sanofi and GlaxoSmithKline, the companies that are leading joint vaccine projects respectively.

The pressure on companies that are developing COVID-19 treatments and vaccines is even higher currently, following a number of study pauses of potential vaccines and treatments.

This includes AstraZeneca - the company paused its Oxford University-partnered vaccine study in September following a adverse event within its UK-based phase 3 trial. Earlier this week, Johnson & Johnson also announced  that it had voluntarily paused its late-stage COVID-19 study after an unexplained patient illness occurred.

Eli Lilly also announced a study pause this week for its COVID-19 antibody treatment, after an independent data and safety monitoring board (DSMB) highlighted a potential safety issue.

Article by
Lucy Parsons

15th October 2020

From: Regulatory



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