In this week’s news, US FDA reopens drug quality metrics programme, MHRA updates Brexit prep guidelines, EMA has more advice on preventing shortages and more…
US FDA extends sign up period for drug quality metrics programme
The US Food and Drug Administration (FDA) has given drug firms more time to sign up to its manufacturing quality metrics feedback programme.
The US regulator announced the extension last month in a move prompted by requests for more information.
Plans for the programme were announced last year. At the time the agency said it was designed to encourage drug firms to seek formal meetings at which manufacturing quality metrics will be discussed.
The FDA said, “To be considered for the program, a company should submit a statement of interest for participation to OPQ-OS-QualityMetrics@fda.hhs.gov. “
EMA aims to help industry and regulators prevent drug shortages
The EMA has published advice to help drug companies and regulators prevent shortages.
The two new guidance documents, available here and here, outline what the agency expects of drug companies and national regulatory agencies if shortages occur. The documents also discuss signals that can be used to anticipate potential supply issues.
The EMA wrote, “An essential element to a harmonised approach for reporting and managing shortages is the use of a harmonised definition of a shortage. The lack of a common definition has meant that the detection and coordination of the management of shortages in the Union (EEA) has been inconsistent.
“The differences in the reporting requirements of shortages also meant that comparisons across countries were not possible. This guidance which is based on a common definition agreed by all stakeholders, gives recommendations to facilitate the detection and reporting from marketing authorisation holders to competent authorities about impending shortages.”
MHRA urges pharma firms to register in case of “no deal” Brexit
The UK MHRA has updated its guidance for drug makers, urging them to register with the agency to prevent any delays if the UK withdraws from the EU.
The UK regulator updated its information page last week.
Also in the news
Contract Pharma reported on the growth of the CMO sector in China.
European Pharmaceutical Review reported that global supplies of the blood thinner heparin are low as a result of a swine fever outbreak that has killed millions of pigs in China.
According to a Bloomberg report, a subsidiary of Fresenius SE has started limiting allocations of the drug “due to a potential shortage of raw ingredient.”
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, spoke with the LA Times about the future of medicine.
Nature reported about efforts to reset the body’s biological clock.
Developments of note in the contract development and manufacturing space.
Catalent has said it will invest $9 million in a new clinical supply facility in San Diego. The facility, which will make drug candidates for studies in the US and elsewhere, is due to open in the summer of 2020. See press release.
Lonza and Chr. Hansen have received anti-trust approval for their recently established “biotherapeutics” joint venture. The company – called BacThera – will make live biotherapeutic products for pharmaceutical customers. See press release.
Wuxi Apptec has launched a DNA encoded library service. According to a press statement the aim is to provide “cost-effective and efficient hit finding services to expedite early drug discovery and bring new medicines to patients faster.”
SK Holdings has started targeting global pharmaceutical companies according to the Korea Biomedical Review.