In this week’s news, EC wants input on safety monitoring revisions, EDQM clarifies online submission guidelines and more…
Drug maker feedback sought on planned pharmacovigilance revisions
The European Commission wants industry feedback on plans to change pharmacovigilance rules for approved drugs.
The Commission issued the call last week, giving drug makers until mid-October to contribute.
The planned revisions include requiring drug firms that subcontract pharmacovigilance activities to include “a description of the process in place to ensure third parties are in compliance.”
Companies will also have to monitor EudraVigilance “in a manner proportionate to the risk, together with other available data sources,” rather than just “to the extent that they have access” as they had been required to do previously.
Full details available here.
EDQM rejigs electronic application guidelines for CEPs
The European Directorate for the Quality of Medicines (EDQM) has updated guidelines on electronic applications for Certificates of suitability.
Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) – are issued to substances – including APIs – deemed to be safe by the EDQM.
Drug firms and CDMOs can request them online. Under the new guidance it is mandatory to include previously assessed and approved information from the “baseline (full dossier)” when switching to eCTD from another format.
Also in the news
Reuters reported that the US is to invest $3 billion in COVID-19 vaccine supply chain.
The EU is to return millions of doses of J&J’s COVID-19 vaccine imported from Africa according to the Wall Street Journal.
Efforts to increase vaccine rates in China have hit supply related hurdles according to Reuters.
The Pink Sheet reported that the EMA has outlined plans for the use of real-world evidence in clinical trials. See here (subscription required).
The publication also covered the completion of GDUFA III talks in the US. Plans for post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included.
Some developments of note in the contracting sector:
Plants owned by Catalent and Delpharm have been approved to make millions of Pfizer, Moderna COVID-19 vaccine doses by the European Union. Read more at FIercePharma.
Tech transfer to Thermo Fisher Scientific played a vital role in the production of Pfizer’s COVID-19 vaccine according to a Wall Street Journal article.
Recipharm has launched a new laboratory services business base at a new analytical laboratory at its facility in Bengaluru, India. See press release.
Lonza has announced plans to set up a drug production services unit in Guangzhou, China.
BioDuro-Sundia has agreed to buy an oral solid dose manufacturing facility in Irvine, California.
Brazil’s Eurofarma will provide fill-finish service for Pfizer/Biontech’s COVID-19 Vaccine Doses for the Latin American market under a new agreement.
Gene therapy CDMO Forge Biologics has expanded its leadership team with two key hires in process development and medical affairs. See press release.
Bioprocess Insider says WuXi Biologics is expanding bioreactor capacity at its site in Worcester, Massachusetts from 6,000 L to 24,000 L.
Quotient Sciences will invest £6.3 million-pound in its recently acquired manufacturing facility in Alnwick, UK.
Cipla and Kemwell Biopharma have signed a joint venture agreement to develop, manufacture and commercialise biosimilars for global markets. See press release.