In this week’s news, US aims to boost complex generics, EMA and FDA team up on device UDIs, Brexit planning gathers pace, and more…
US FDA aims to make complex generic development less complicated
First up this week, the US FDA says it wants to promote development of so called complex generic drugs.
‘Complex generics’ is the term applied to drugs that, as a result of their active ingredients, formulation or delivery systems, are hard to manufacture and, says the agency, less likely to be “genericized.”
“There are a number of complex drugs that are no longer protected by patents or exclusivities that would forestall generic approval, yet they continue to face no generic competition owing to the difficulty of developing generics.
“The agency has advanced many new policies to help promote generic competition to complex medicines once patents and exclusivities have lapsed, and we’re planning additional policy steps in 2019.”
These policies include draft guidance on establishing active ingredient sameness and a pledge to support the development of analytical tools and in vitro tests intended to aid firms making complex generics.
Read the full statement here.
EMA and FDA agree to co-operate on medical device tracking
Regulators on both sides of the Atlantic will make sure computers used to track device IDs – known as unique device identifiers – are compatible.
The co-operation agreement was announced last week by the EU-US executive work group on trade. The aim is to facilitate improved device tracking and to bring EU systems into line with those already established in the US.
The EU has also agreed to work towards single audit reports as are specified under a programme developed by the International Medical Device Regulators Forum (IMDRF).
According to the EU “The idea behind the Medical Devices Single Audit Programme (MDSAP) is that recognised auditing organisations can conduct a single audit of a particular medical device manufacturer that will satisfy the requirements of multiple regulatory jurisdictions as regards Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) requirements.”
EMA updates Brexit advice for drug makers
The EMA has issued guidance making clear what it expects of drug companies after the UK withdraws from the EU.
The guidance covers a range of scenarios – from the UK departing without a trade deal to the UK leaving under the currently agreed withdrawal plan.
The Agency said the guidance “aims to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines in the EU for the benefit of patients, based on the assumption that the UK will become a third country as of 30 March 2019.”
BSI tells device firms to shift CE docs to Amsterdam
In other Brexit related news, UK standards group BSI has advised medical device manufacturers to move their CE documents to a notified body (NB) it has established in the Netherlands.
The group issued the advice in a note, explaining, “Once CE certificates lose their validity post 29 March, they will not be able to be transferred or migrated to an EU NB. Products will lose market access, and a new conformity assessment will be required.”
BSI added that while it cannot mandate medical device firms to move CE certificates “very strongly recommends manufacturers migrate their existing BSI UK NB (0086) CE certificates to BSI NL NB (2797) as a matter of urgency.”
The organisation warned that failure to do so would likely prevent manufacturers from accessing the EU market.
Drug stockpiling ramps up ahead of Brexit
The final Brexit-related development this week is a report from Reuters covering the acceleration of patient and carer drug stockpiling in the UK.
Also in the news
US President Donald Trump has come up with another plan designed to reduce drug prices. The focus this time are the rebates paid to pharmacy benefit managers. Read more at Bloomberg.
US reliance on pharmaceutical products made in China could be a security risk according to military officers association group MOAA.
Sanofi CEO Oliver Brandicourt has been appointed chairman of US drug industry group PhRMA. Read more here.
Swiss CDMO Lonza has announced that COO Mark Funk will become CEO on March 1. He will replace Richard Ridinger who is retiring.