In this week’s news, EU-US inspection deal expanded, EMA details Brexit impact, US IP protections in trade deals mulled and more…
Bulgaria and Cyprus added to EU-US mutual facility inspection accord
The US FDA will now accept plant inspection data from Bulgaria and Cyprus under a deal with the EU.
The agency expanded the EU-US mutual recognition deal last week, explaining that Bulgarian and Cypriot regulators’ inspection practices are consistent with its own.
The decision means the US FDA can now use drug and API plant inspection data from 24 EU member states rather than conduct its own inspections.
The EU-US mutual recognition deal was agreed in 2017. The idea is to reduce the number of inspections manufacturers must undergo. It also allows regulators to make more efficient use of resources.
The expansion may also make it easier for manufacturers in Bulgaria and Cyprus to access the US market.
Read more at the EMA website.
EMA outlines negative impact Brexit had on drug safety activities in 2018
Preparations for the UK’s withdrawal from the EU forced the EMA to halt development of 119 guideline documents.
The EMA outlined the disruption caused by Brexit in its annual report. It said efforts to expand drug safety monitoring programmes and establish comparability rules for advanced medicines were affected.
The agency wrote that development of a good pharmacovigilance practice (GVP) module specific to elderly patients, which will be a tool to monitor the benefit-risk profile of medicines in the elderly population, was suspended.
It said, “This population represents a large number of patients, yet is under-represented in clinical trials, and exhibits a variability that is best addressed by RWD [real world data] collection.”
Development of guidelines on gene therapies was also halted to allow the EMA to move from London to its new home in Amsterdam.
See the full report here.
IP protections in US trade deals may not help pharma, says study
Drug intellectual property protections negotiated in trade deals struck by the US may be less beneficial than was previously assumed.
According to a study in the New England Journal of Medicine (NEJM), such agreements have not led to more pharmaceutical manufacturing jobs or a more even distribution of drug prices.
The authors looked at the impact of previsions designed to expand regulatory data protection, patent term extension or exclusivity periods in trade deals signed by the US in recent decades.
The found that, despite these provisions, US pharmaceutical companies have continued to offshore manufacturing and shift patents to low-tax countries.#
US FDA to modernize drug reviews says CDER chief
The US FDA will “modernize” how it reviews new drug applications (NDAs) and biologic license applications (BLAs) according to Center for Drug Evaluation and Research (CDER) Director Janet Woodcock.
According to RAPS, Woodcock told delegates at the Food and Drug Law Institute’s annual conference that the changes focus on integrated reviews for marketing applications, IND management and post market safety testing.
Read the full RAPS report here.
Also in the news
According to STAT, the US FDA imposed restrictions on who can be given the vaccine over concerns it can increase infection risk in some people.
Some developments in the CDMO sector this week:
Thermo Fisher will spend $125m to expand acquisition target Brammer Bio. The firm announced its intention to up capacity at the gene therapy contractor in its most recent financial results. Read more at Bioprocess Insider.
Meanwhile, Fujifilm Diosynth has said it will up cell culture capacity at its Billingham, UK site. Samsung Biologics has signed an immunochemotherapy development contract with fellow Korean firm GI Innovation.
Blockchain technology has a lot to offer the pharmaceutical industry according to a report by specialist site, Blockchain publisher.
AstraZeneca has hired Transgene to help work on viral immunotherapies according to Reuters.
The Economic Times reported that sub-standard medicines are more of a problem than counterfeits in India.
FiercePharma reports that Merck & Co is to reorganize its drug manufacturing operations.