In this week’s news, EU rejigs site registration rules, Commission plans environmental regs for drug industry and more!

Drug makers call on US FDA to back EPCIS ahead of DSCSA

The drug industry wants the US FDA to endorse use of Electronic Product Code Information Services (EPCIS) for tracing medicines and finalize guidance on the exchange of product information.

At a meeting this week industry urged the agency to back the EPCIS – which is a GS1 standard for creating and sharing visibility event data, both within and across enterprises.

Drug makers, CDMOs and distributors argued the move would aid the uptake of exchanging product data ahead of the Drug Supply Chain Security Act (DSCSA) November 2023 deadline.

EC plans regulations for pharmaceutical in environment

The European Commission has asked researchers to develop a concept paper proposing a regulatory framework for pharmaceuticals in the environment.

According to a Commission notice published last week, the paper will be written by a working group set up in March last year to assess the environmental impact of the pharmaceutical industry.

EMA changes site registration requirements for centrally authorised products

The EMA has asked drug firms to register new sites involved in the production of centrally authorized medicinal products before they submit any associated regulatory documents.

The change – which requires firms to register sites through the Agency’s Organisation Management Service (OMS) – is designed to streamline validation procedures.

The EMA said it would “like to emphasise the importance of these site/organisation registrations in OMS prior to pre- and post-authorisation submissions, in order to avoid any delay in the start of these procedures, as this would constitute a validation blocking issue.”

EU rejigs guidelines for trials involving human cells

The European Union has expanded its guidelines for clinical trials involving human cells. The text now covers human cells that have been genetically modified without viral vectors. See press statement.

Also in the news

DCAT looked at the expanding market for parenteral drugs –and the opportunities for the CDMO sector.

A report issued by CPhI Informa markets covered the growth of China’s CMO sector, citing recent regulatory changes as key.

The Pink Sheet reported that the US Government is looking for additional CDMOs for its pandemic preparedness programme.

The publication also examined how the US FDA is likely to use a “hybrid” approach to facility inspections.

Politico looked at how a deal struck by US 2020 election loser Donald Trump is hampering global vaccination efforts.

The Wall Street Journal reported that Johnson & Johnson plans to split into a drug business and a medical device business.

RAPS covered US President Joe Biden’s decision to nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time.

CDMO trends

Some developments of note in the contracting sector:

Sever Pharma Solutions will acquire Putnam, Connecticut-based Foster Delivery Science (FDS) to add the latter’s Long-Acting Implantable delivery system to its offering.

Jubilant HollisterStier held a ground-breaking ceremony at its campus in Spokane, Washington to mark a planned expansion. The CDMO will add a high-speed filling line and lyophilizers, which will increase sterile injectable production capacity by 50%.

And Jubilant Biosys Limited announced plans to expand its facilities to support its discovery chemistry and in-vitro ADME services.

Hoth Therapeutics has hired STA Pharmaceutical for process development and manufacturing of the API for HT-KIT, a candidate cancer drug.

Fujifilm Irvine Scientific has announced plans to expand its Armstrong R&D Center of Excellence at its headquarters in California.

Baxter Biopharma Solutions, the CDMO arm of healthcare giant Baxter, will shell out $100 million to expand its fill-finish manufacturing facility in Germany according to Fierce Pharma.