In this week’s news, FDA clarifies generics review process, EU relaxes rules to try and stop post Brexit disruption and more…
US FDA finalizes guidelines for “controlled correspondence” for generics
The US FDA has clarified rules on how it will handle correspondence from generics firms with drugs under review.
The US regulator made the clarification in final guidance issued last week.
It said the document “provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development.”
“Controlled correspondence” is defined as requests for information related to involve the evaluation of clinical content or the review of bioequivalence (BE) protocols for drugs that reference listed drugs.
The agency also specifies that correspondence is submitted through the CDER portal https://edm.fda.gov/.
EMA says firms with drugs that ref UK sites must prep for Brexit
A “large number” of centrally authorized products (CAPs) reference UK sites and activities that need to be removed after Brexit according to the EMA.
The agency flagged the issue in a recent webinar explaining, in addition to sites, UK-based representative listed in CAPs will need to be replaced by people based in the European Economic Area or Northern Ireland.
The EMA also said it has started to allow firms with UK authorized products to change the country code in their authorizations. The agency wants EMA wants all those containing the term “United Kingdom (Northern Ireland)” to be updated by the end of the year.
The notes from the webinar are available here.
EU outlines temporary rules to help prevent UK drug shortages
In related news, the European Union has issued plans to try and help the UK maintain drug supplies after it crashes out of the bloc on December 31.
According to a document posted this week, the EU wants to reduce the impact of Brexit on medicines supplies coming to the UK from the EU and Northern Ireland, where EU law will still apply.
The EU said it will temporarily free companies shipping to the UK of the obligation to remove safety features. It will also allow quality control testing to be carried out in the UK.
Finally, the EU said it would delay punishing transgressions caused by “the absence of manufacturing authorization holders in Northern Ireland.”
See for declaration document here.
Also in the news
The pandemic will have a lasting impact on the role US FDA inspections according to the Pink Sheet.
The Spokesman looked at Jubilant Hollistersier’s efforts to make COVID-19 vaccines. According to the article, the CDMO is able to make 500,000 doses per day at its facility in Spokane.
US vice president Mike Pence visited Catalent’s biologics manufacturing plant in Bloomington, Indiana according to Indystar.
Politico looked at failed plans to let the US develop “herd” immunity to the coronavirus.
Some developments of note in the contracting sector:
Thermo Fisher Scientific plans to build a cGMP plasmid DNA manufacturing facility in Carlsbad, California.
GT Biopharma has hired Cytovance to make three of its candidate products using its bacterial and mammalian cell lines and for GMP manufacturing services.
Vectura Group has expanded its capavity for the production of highly potent active pharmaceutical ingredients (HPAPIs) at its facility in Chippenham, UK.
Controlant has announced it is providing monitoring and Supply Chain Visibility services to Pfizer, in relation to the delivery of its COVID-19 vaccine.
Lonza will build a manufacturing plant at its facility in Visp, Switzerland for the production of voclosporin under a deal with Aurinia Pharmaceuticals.