In this week’s news, FDA stresses focus on quality of generic imports, WHO says GMP key to superbug fight, Health Canada plans fee hike and more…
US FDA commits to policing quality of generic imports
The US FDA has moved to address concerns about the efficacy, quality and safety of imported generics.
Center for Drug Evaluation and Research director, Janet Woodcock, wrote about the subject last week. She said agency efforts to increase access to generics include quality oversight.
“The success of the FDA’s generic drug program…has often been described in terms of our ability to efficiently determine the safety and efficacy of generic drugs under review for approval and how many new generics we subsequently approve as a result.
“However, these metrics for efficiency and quantity would not be relevant if we cannot also ensure that our review and approval process meets the highest standards, and that once approved, these drugs, no matter where they are made, are manufactured under conditions that maintain good quality.”
Sartan quality concerns
Woodcock’s comments coincide with an FDA report on drug quality. They also come amid renewed concerns about generic valsartan – a heart drug – made outside the US.
A 2018 study suggested some imported sartans – including valsartan – may contain cancer-causing impurities.
According to RAPS, FDA teams are inspecting facilities and processes at overseas manufacturers.
Health Canada to rejig fees for drug manufacturers
Selling drugs in Canada will cost more under a plan outlined by the country’s regulator.
The plan will increase drug and medical device firms fees for agency services – product reviews, licenses etc – and reduce taxpayer contributions. The changes comes into effect in 2020.
Health Canada said, “The globalization of drug and medical device industries means that many products follow complex pathways through multi-step supply chains prior to reaching Canada.
“These new realities have changed the environment for regulating these products, increasing the complexity of regulatory work and creating new regulatory challenges for Health Canada.”
At present, Health Canada recovers 43% of its costs from industry fees. The rest of its activities paid for using public funds.
GMP vital to fighting superbugs says WHO
The World Health Organisation (WHO) says GMP is key to halting the spread of antibiotic resistant superbugs.
The WHO set out its position last week. The aim is to help regulators and drug firms consider environmental aspects of GMP in decision making.
The management of water used in antimicrobial production is a major focus.
According to the WHO, “Poor control of waste and wastewater, such as that encountered in some of the countries who are major global producers of APIs and FPPs, can often lead to the entry of antibiotics into waters that are contaminated with pathogenic bacteria from untreated sewage. This increases the risk of the development of antimicrobial resistance.”
EC says Korea-made drug ingredients meet quality standards
The European Commission has confirmed that South Korean regulations applying to API production are equivalent to those in EU.
The decision makes it easier for drug firms and contract manufacturing organisations (CMO) to source APIs from Korean suppliers.
South Korea joins Australia, Brazil, Israel, Japan, Switzerland and the US on the list of non-EU countries deemed to have regulatory systems that are equal to those in the EU.
Also in the news
PMLive looked at rare disease research. Clinical development is a considerable challenge according to experts quizzed for the article.
The Medicine Maker has published its “power list” of pharmaceutical industry movers and shakers. Included this year are leading scientists, regulators and top industry execs.
Bioprocess Insider reported FDA backing for innovation in field of cell and gene therapy production.
Some developments in the CDMO space:
Catalent’s acquisition of Paragon Bioservices is a further indication of its shift towards biologics according to BPI; Thermo Fisher is to buy an API making site in Ireland from GSK; and Lonza has partnered with biologics production platform developer Synpromics.