In this week’s news, US FDA updates on inspections and generic office activities, EMA aligns on electronic drug product info and more

 

US FDA quality office committed to on-site inspections

The US Food and Drug Administration’s (FDA) quality office says onsite facility inspections will remain its major focus.

The Office of Pharmaceutical Qulity (OPQ) made the comments in a report this week, explaining that, although the use of remote assessment tools increased during the pandemic, it is still committed to visiting facilities.

It wrote that “The tools leveraged and refined during the public health emergency will continue to be useful in the future, though inspections will remain the irreplaceable standard,”

US FDA’s generic office focused on COVID-19 meds in 2021

The US FDA’s Office of Generic Drugs also published its annual report. 

According to the agency, its main focus was the approval of potential treatments and supportive therapies for patients with COVID-19.

It also revealed that more than 75 original ANDAs had been approved, some in record time, since the beginning of the pandemic. 

EMA adopts electronic product information standards

The EMA has adopted a common electronic product information (ePI) standard for human medicines.

The move – announced this week – is designed to “pave the way for wider dissemination of the unbiased, up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels.”

 

Also in the news

The Washington Post covered the appointment of Robert Califf as the next US FDA commissioner.

The Financial Times reported that Moderna is in talks to set up a manufacturing facility in the UK.

Endpoints wrote about the US FDA’s decision to rethink plans to correct manufacturing volume data from drug companies and CDMOs.

Mitacs looked at signs of a biomanufacturing revival in Canada. 

The Pink Sheet looked at drug and CDMO industry requests for the FDA to clarify its policy on on-site inspections.

STAT looked at lawsuits, filed by patient advocacy groups against the South Africa government, about COVID-19 vaccine manufacturing and distribution contracts.

 

CDMO trends

Some developments of note in the contracting sector:

Thermo Fisher Scientific has launched a cell and gene therapy packaging and distribution service, designed to support production from clinic to commercial launch for patients across the US and Europe.

Catalent plans to expand its facility in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China. The firm said it would increase capacity for temperature-controlled storage, distribution and secondary packaging capabilities.

Recipharm has acquired Arranta Bio, citing its capabilities in microbiome therapeutic products and mRNA clinical production as the driver. The Sweden-based CDMO has also acquired Vibalogics, a contract development and manufacturing organization (CDMO) that, like Arranta, is an Ampersand Capital Partners portfolio company.

US CDMO National Resilience – also known as Resilience – signed a manufacturing services agreement with Takeda’s Plasma-Derived Therapies Business Unit.

Moderna has announced a long-term collaboration to increase capacities for the compounding, aseptic filling, inspection, labelling and packaging of MRNA medicines with ROVI, located in Madrid, San Sebastián de los Reyes and Alcalá de Henares.