Pharmaceutical Industry News Roundup: February 2020

by Staff writer

Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection from February:

EMA to support development of vaccines and treatments for novel coronavirus disease COVID-19—European Medicines Agency (EMA)

The EMA is actively supporting the development of medicinal products for the treatment and prevention of the coronavirus. The agency is currently examining potential antivirals and vaccines to treat or prevent novel coronavirus infections.

Read the full release

Providing regulatory submissions in electronic format — certain human pharmaceutical product applications and related submissions using the eCTD specifications guidance for industryU.S. Food & Drug Administration (FDA)

This new guidance from the FDA describes how sponsors must present the content they submit to the agency electronically for all submission types. This guidance applies to submissions under section 745A(a) of the Federal Food, Drug, and Cosmetic Act.

Visit the FDA website for all the latest updates

WHO outlines steps to save 7 million lives from cancer—World Health Organization (WHO)

The World Health Organization (WHO) recently warned that if current trends continue, world cancer cases will increase 60% over the next 20 years. To combat this projection, WHO outlines a wide range of interventions to prevent new cases.

Read the news release here

Health Canada begins implementing eCTD for clinical trial applications—Regulatory Focus

Health Canada will now accept certain clinical trial submissions in electronic common technical document (eCTD) format. This announcement comes after a successful pilot program.

Michael Mezher has the full story

A disclosure form for work submitted to medical journals: a proposal from the International Committee of Medical Journal EditorsThe New England Journal of Medicine

The International Committee of Medical Journal Editors (ICMJE) recently published a proposal in the New England Journal of Medicine regarding changes to the ICMJE disclosure form. The goal of the proposal is to remedy misinterpretations by both authors and readers of disclosures.

View the editorial here

Real world evidence – from safety to a potential tool for advancing innovative ways to develop new medical therapiesU.S. Food & Drug Administration (FDA)

The FDA sat down with Jacqueline Corrigan-Curay, M.D., J.D. and David Martin, M.D. of the Center for Drug Evaluation and Research (CDER) and discussed real world evidence in drug development. The interviewees provided their insights and predictions for the emerging science.

Visit the FDA newsroom for all the updates

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