Last week’s round -up;
23 -27 November 2020

published 30 Nov 2020

Updated Ph.Eur. vaccine package to support COVID-19 vaccine development

The EDQM has released an updated set of Ph.Eur. quality standards for vaccines to help support COVID-19 vaccine developers in designing appropriate analytical strategies for candidate vaccines and to ensure their quality and safety. The Ph.Eur. package now includes an additional 17 texts on analytical methods which are referenced in the recently released EDQM text on recombinant viral vectored vaccines for human use but may also be relevant for COVID-19 vaccines based on other technologies. The updated Ph. Eur. vaccines package is available for free from the EDQM website.

New and revised FDA product-specific guidances

The FDA has released 13 new and 21 revised draft product-specific guidances, which are aimed at promoting generic competition by clarifying the agency’s expectations for bioequivalence studies. Eleven of the new and revised guidances concern complex products, such as metered dose inhalers or aerosol foams, and 24 of the guidances concern products without any approved generic competition.

CMDh updates – November 2020

The CMDh has updated the following guidance related to MRP, DCP and National Procedures: · Requirements on Submissions (number and format) for New Marketing Authorisation Applications within MRP, DCP and National Procedures (with tracked changes). · Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures (with tracked changes).

Revised Lapatinib product-specific bioequivalence guidance

The EMA has revised its draft product-specific bioequivalence guidance for Lapatinib 250 mg film-coated tablets. The draft guidance was significantly revised following feedback from the first public consultation, and it is open for a second public consultation until the 31st January 2021.

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