In this week’s news, US talks up EMA partnership, pharma slow to sign up to EU anti fakes system, FDA cuts fees for generics applications and more…
US FDA stresses benefits of EMA collaboration
The US FDA lauded its mutual recognition agreement (MRA) with the EMA this week, suggesting it would help both agencies make best use of resources.
The US regulator made the comments in an FDA Voices blog post, explaining it hopes the agreement will see it conduct fewer overseas plant inspections.
It wrote, “Before the MRA was implemented, the EU and the FDA sometimes would inspect the same facilities in the same year, even if the facility had a strong record of compliance.
“We expect the MRA will reduce this duplication, allowing the FDA and the EU to reallocate their resources towards inspection of drug manufacturing facilities that have potentially higher public health risks.”
The FDA said it will also use EMA data to inform its risk-based site selection model for inspections.
Earlier this month Slovakia joined the accord after its regulators were deemed to be up to standard.
US FDA cuts fees
In other news, the US FDA announced its revised fee structure for drug firms seeking approval through GDUFA II.
According to the PinkSheet generic drug applications will be cheaper as a result of the changes, which come into force on October 1.
The PBOA – the contract manufacturing sector’s industry group – shared a similar view in an article on ContractPharma.
Pharma slow to connect with EU anti-fakes system
Not enough drugmakers have connected with the European Medicines Verification Organisation (EMVO) according to the organisation that runs it.
The EMVO is designed to safeguard medicine supply chains in Europe, with the main focus being to stop fake drugs getting to pharmacies.
The system – which was introduced in February – uses a 2D data matrix (barcode) to track every pack of medicines in Europe. The codes are scanned at all stages of the supply chain, from manufacturing plant to pharmacy.
However, only around 60% of pharmaceutical firms that supply the EU have signed up.
The lack of full engagement could hamper efforts to stop fakes getting into the legitimate supply chain according to EMVO, the organisation that runs the database.
It wrote, “The system can only fully work as intended if all actors are connected to it. ‘Stabilization periods’ allow currently connected supply chain actors to ‘use & learn’ the system in each market.
“Squandering this opportunity means that technical, IT, procedural problems will lead to an actual impact on patient access to medicines. Liability is also engaged for actors who do not use the system at all.”
Also in the news
CDMOs have work to do if they want the ‘full service’ model to succeed according to experts who took part in a DCAT panel.
STAT looked at quality issues facing manufacturers in India.
Pharmabiz reported a surge in ANDAs and tentative approvals for Indian companies in the first half of 2019.
The US FDA’s Center for Drug Evaluation and Research (CDER) Director Janet Woodcock says the National Institutes of Health (NIH) should not be in the business of developing new drugs according to RAPS
The Medicine Maker looked at Merck’s “perpetual preparedness” approach. The firm cites Brexit as a major concern.
The LA Times examined how drugs are named and spoke with the two people who come up with nearly all the generic monikers used in the US.
The US Senate has advanced a Bill designed to reduce drug prices. Read the full story at RAPS.
Some developments of note in the contract development and manufacturing sector:
BIA Separations is working with Novartis’ AveXis unit to advance purification processes used in the production of gene therapies.
The collaboration will initially focus on Zolgensma (onasemnogene abeparvovec-xioi), the spinal muscular atrophy therapy that was recently approved by the US FDA. See press release.
The news comes a week after Catalent set up a dedicated Zolgensma manufacturing space at a facility operated by its Paragon Gene Therapy division. See press release.
WuXi AppTec’s API subsidiary STA Pharmaceutical has passed a US FDA inspection. The regulator visited an analytical service unit in Shanghai and API and manufacturing plants in Changzhou. See press release.
Italian API firm Olon S.p.A. is building a GMP manufacturing plant at its facility in Capua. See press release.