In this week’s news, US FDA kick off GDUFA III discussion, New guidance on Covid-19 sample media and more…
US FDA outlines GDUFA III plan
The US FDA has begun the process for reauthorizing the Generic Drug User Fee Amendments III (GDUFA).
GDUFA is a law designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry.
The Agency discussed GDUFA III last week. According to Generics Bulletin the legislation could include new provisions for complex generics – including a two-month filing review period before the user fee clock is triggered.
It may also include measures to encourage interaction between the agency and sponsor and to provide opportunities for in-depth discussions with the FDA after receipt of a complete response letter.
EMA issues new guidelines for pharmaceutical water quality
The EMA has issued updated guidelines on the quality of water used in the production of pharmaceuticals.
The guidelines – which will replace 20-year old guidelines when it comes into effect in 2021 – provide recommendations for the minimum acceptable quality of water in different applications.
The EMA said, “This document is intended to provide guidance to the industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use and should be considered for new marketing authorisation applications, as well as any relevant variation application to existing marketing authorisations.”
Specific topics include the manufacture of sterile and nonsterile products, active substances and water used for cleaning.
US FDA issues pandemic transport media guidelines
The US FDA has issued guidance designed to boost the availability of transport media for SARS-CoV-2 clinical specimens.
The guidance applies to media for molecular and antigen diagnostic tests. The FDA sets out policies for the manufacture of viral transport media.
EC issues MDR implementation advice
The European Commission has issued advice on the implementation of the Medical Device Regulation (MDR).
The Commission said, “Transparency is a key objective of the Medical Devices Regulation (MDR) aiming at providing a large access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market.”
It also issued a fact sheet explaining what information will be available to the public.
More concerns about vial glass shortage
Concerns are growing that a shortage of glass used to make vials will impact the availability of SARS-CoV-2 vaccines.
According to a report in Plastics Today demand for Topas-branded cyclic olefin copolymer (COC) – an alternative to borosilicate glass – has increased from manufacturers of syringes and containers.
A separate report by Packaging Today revealed that Italian glass packaging firm Stevanato Group will supply CEPI with 100 million glass vials to hold up to two billion doses of Coronavirus vaccine.
CEPI CEO Richard Hatchett said, “In addition to accelerating the development of COVID-19 vaccine candidates, CEPI is working with partners around the world to begin the manufacture of millions of vaccine doses so that, should a candidate be proven to be safe and effective, it will be available to those in need without delay.
“In order to achieve this aim, CEPI is supporting the procurement of critical vaccine packaging components, including glass vials. We are therefore delighted to be working with the Stevanato Group to secure high-quality pharma vials for two billion doses of vaccine, helping to maximise our efforts to advance the development of a COVID-19 vaccine and bring this pandemic to an end as soon as possible.”
Also in the news
The US government has ordered of 100 million doses of Pfizer’s candidate SARS-CoV-2 vaccine for $1.95 billion. The agreement allows it to buy up to 500 million additional doses. See press release.
US President Donald Trump is considering an executive order to lower drug prices according to The Hill.
The WHO has established a Covdi-19 law lab to gather and share legal documents from over 190 countries across the world to help states establish and implement strong legal frameworks to manage the pandemic. See press announcement.
The EU has signed a €750bn package to help member states recover from the pandemic. Read more at the Telegraph.
Pharmaintelligence looked at potential problems drug firms and CDMOs in Northern Ireland will face when the UK officially leaves the EU on December 31.
Some developments of note in the contracting sector:
Thermo Fisher saw its Q2 earning rise as a result of Covid-19 related contracting work. Read more at MassDevice
Forge Biologics wants to raise money to expand AAV manufacturing CDMO capabilities and develop a gene therapy pipeline.
Catalent plans to invest €27m in its facility in Limoges according to reports in the French press.
CMIC group has set up an API making CDMO for biologics. Read more at Contract Pharma.