Distribution/Supply Chain
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
Canada’s health products regulator is inviting feedback on a range of new and revised guidelines and regulatory tools that explain how drug and device companies will be able to comply with significant changes proposed to its shortages framework.
Compounding pharmacies have 60 days, and outsourcing facilities 90 days, to transition patients to branded products.
Efforts to de-risk the pharma supply chain’s reliance on China likely will not completely disappear if the BIOSECURE proposal dies.
Marketing authorization holders are being encouraged to insert their data on shortages of centrally authorized medicines in the new platform before it becomes mandatory to do so in February 2025.
Drug companies are being invited to participate in a new pilot project that the five Nordic countries will run to see if they can improve the availability of certain critical products that are used in hospitals.
More than 90% of companies have submitted new medicines packaging artwork to the UK’s drug regulator, the MHRA. The agency urges the remaining marketing authorization holders of its 31 December deadline to comply with the new Windsor Framework arrangements.
Throckmorton is known for enhancing the FDA’s drug shortage work by building bridges between the compliance and quality teams, as well as opioid oversight.
The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.
With a looming deadline of 1 January 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a “UK only” label for all packs as well as UK-based batch testing for biologicals.
As Sandoz publishes a report on US drug shortages, including a call for policy and other improvements, the firm’s North America head and AAM Chair Keren Haruvi discussed potential solutions to ongoing supply-chain failures.
The US FDA Commissioner pushed for rebalancing the US’s pharmaceutical supply chains while also stressing that US-China commerce has a role that would be risky to compromise.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate Pharma data to highlight the likely holes in pharma’s supply chain.
There are increased complexities associated with potential regulatory divergence between the UK and the EU when the Medicines and Healthcare products Regulatory Agency takes over responsibility for UK-wide new drug approvals from January 2025, writes the ABPI's Rick Greville.
With the BIOSECURE Act halfway to congressional approval, stakeholders are pushing for a financial boost to ensure the US gains the business Chinese companies will lose, but that may be a big lift.
The Democratic Republic of Congo, the country worst hit by the mpox crisis, has now received the first batch of vaccines for the disease. Meanwhile, the World Health Organization is expected to complete its review for emergency use listing of mpox vaccines soon.
The World Health Organization says its new 98-page guidance dealing with wastewater and solid waste management for antibiotic manufacturing is a first of its kind and addresses an important but neglected issue.
AI has the potential to save vast amounts of time and money by optimizing pharma supply chain processes, but companies must think about legal risk and liability from all angles, Ewan Townsend, partner at law firm Arnold & Porter, tells the Pink Sheet.
The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.